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WU-KONG28 Trial

The first multinational Phase 3 trial of oral sunvozertinib (Zegfrovy) vs platinum-pemetrexed chemotherapy in treatment-naïve EGFR exon20-insertion NSCLC. Presented at ASCO 2026 (LBA8500), published simultaneously in NEJM.

ASCO 2026 · LBA8500 · NEJMEGFR Exon20ins NSCLC1st-LinePhase 3Sunvozertinib (Zegfrovy) · Dizal

KOL Leaders Discussing WU-KONG28

Masahiro TORASAWA, MD. PhD.
Masahiro TORASAWA, MD. PhD.
@M_Torasawa
4,757 impressions
Eric K. Singhi, MD
Eric K. Singhi, MD
@lungoncdoc
4,537 impressions
Dr Amol Akhade
Dr Amol Akhade
@SuyogCancer
3,761 impressions
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
3,436 impressions
Dr. Estela Rodriguez
Dr. Estela Rodriguez
@Latinamd
2,042 impressions
Uğur Özkerim
Uğur Özkerim
@UOzkerim
1,996 impressions
Yakup Ergün
Yakup Ergün
@dr_yakupergun
1,223 impressions
Rami Manochakian MD, FASCO Cancer Education
Rami Manochakian MD, FASCO Cancer Education
@RManochakian
1,036 impressions

Key Slides & Data

Dr Amol Akhade
Dr Amol Akhade @SuyogCancer
#ASCO26 · May 29, 2026
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Abstract LBA8500 X Sunvozertinib monotherapy versus platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR exon20ins: Primary analysis of a multinational phase 3 randomized study (WU-KONG28). Snangnai, China Background: Sunvozertinib has been granted accelerated approval in the US and China for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor exon 20 insertion mutations (EGFR exon20ins) who failed platinum-based chemotherapy, based on results from two phase 2 single arm pivotal studies (WU-KONG1B [NCT03974022] and WU- KONG6 [NCT05712902]). WU-KONG28 (NCT05668988) is a multinational randomized confirmatory phase 3 study to compare sunvozertinib versus platinum-based chemotherapy as first-line treatment in advanced NSCLC patients with EGFR exon20ins. Here we reported the primary analysis of WU-KONG28 study results. --- Methods: Eligible patients were randomized in a 1:1 ratio, stratified by baseline brain metastasis status, to receive either sunvozertinib 300 mg once daily or chemotherapy (carboplatin [AUC5] and pemetrexed [500 mg/m²]) once every 3 weeks for up to 6 cycles, followed by pemetrexed maintenance therapy until disease progression or other discontinuation criteria were met. Patients in the chemotherapy arm could cross over to receive sunvozertinib upon confirmed progressive disease by the blinded independent central review (BICR). The primary endpoint was progression free survival (PFS) assessed by BICR per RECIST 1.1. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DoR), and safety profile. PFS and os were analyzed using log-rank test and Cox proportional hazards model. The data cutoff date was Jan 16, 2026. --- Results: A total of 324 patients were randomized to receive sunvozertinib (N=163) or chemotherapy (N=161). Baseline characteristics were generally balanced between the two arms. PFS by BICR was significantly longer with sunvozertinib than chemotherapy (median: 10.3 vs 7.5 months; hazard ratio [HR]: 0.65, 95% confidence interval [CI]: 0.50, 0.85, p=0.0008). The PFS benefit was consistent in trends across subgroups. In the chemotherapy arm, 90.2% of patients with BICR-confirmed disease progression crossed over to receive sunvozertinib. The os data were immature. Patients in the sunvozertinib arm showed higher confirmed ORR (58.9% vs 31.1%) and longer median DoR (11.2 vs 7.1 months). Safety profile of sunvozertinib was similar to what was previously reported. Drug-related treatment emergent adverse events (TEAEs) leading to treatment discontinuation occurred in 7.4% of patients. No drug-related TEAE leading to fatal outcome was reported. --- Conclusion: Sunvozertinib demonstrated significantly superior antitumor efficacy than chemotherapy with a manageable safety profile. These results support sunvozertinib as a first-line treatment for advanced NSCLC harboring EGFR exon20ins.
Yakup Ergün
Yakup Ergün @dr_yakupergun
#ASCO26 · May 29, 2026
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The NEW ENGLAND JOURNAL of MEDICINE ORIGINAL ARTICLE f X in x First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations Authors: Caicun Zhou, M.D., Ph.D., Laurent Greillier, M.D., Ph.D., Geoffrey Liu, M.D., Thomas John, M.B., B.S., Ph.D., Ligang Xing, M.D., Ph.D., Dariusz Kowalski, M.D., Ph.D., Regan M. Memmott, M.D., Ph.D., +23 , for the WU-KONG28 Investigators* Author Info & Affiliations Published May 29, 2026 --- 100 Median 90 Progression-free Survival 80 (95% CI) 70 mo Percentage of Patients 60 Sunvozertinib 10.3 (8.3-14.0) Chemotherapy 7.5 (6.7-8.5) 50 46.1 Hazard ratio for disease 40 33.2 progression or death, 30 0.65 (95% CI, 0.50-0.85) Sunvozertinib P<0.001 20 26.7 Chemotherapy 10 17.1 0 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization No. at Risk Sunvozertinib 163 143 108 74 60 48 34 26 18 9 3 0 Chemotherapy 161 128 84 51 28 22 14 7 6 2 1 0 --- Progressive Stable Partial Not evaluable disease disease response A Best Change in Tumor Size in the Sunvozertinib Group 100 80 60 Percentage Change from Baseline 40 20 0 -20 -40 -60 -80 -100 Patients B Best Change in Tumor Size in the Chemotherapy Group 100 80 60 Percentage Change from Baseline 40 20 0 -20 -40 -60 -80 -100 Patients C Duration of Response 100 80 Percentage of Patients with Response 60 40 Sunvozertinib 20 Chemotherapy 0 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization No. at Risk Sunvozertinib 96 91 64 48 36 28 22 17 9 4 2 0 Chemotherapy 50 44 29 13 9 5 1 1 1 0 0 0
Rami Manochakian MD, FASCO Cancer Education
#ASCO26 · May 29, 2026
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MEDICINE OF 1926 1812 NEW NOR ENGLAND The NEW ENGLAND JOURNAL JOURNAL of MEDICINE ORIGINAL ARTICLE f X in x First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations Authors: Caicun Zhou, M.D., Ph.D., Laurent Greillier, M.D., Ph.D., Geoffrey Liu, M.D., Thomas John, M.B., B.S., Ph.D., Ligang Xing, M.D., Ph.D., Dariusz Kowalski, M.D., Ph.D., Regan M. Memmott, M.D., Ph.D., +23 , for the WU-KONG28 Investigators* Author Info & Affiliations Published May 29, 2026
Jordi Remon
Jordi Remon @JordiRemon
#ASCO26 · May 29, 2026
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100 Median 90 Progression-free Survival 80 (95% CI) 70 mo Percentage of Patients 60 Sunvozertinib 10.3 (8.3-14.0) Chemotherapy 7.5 (6.7-8.5) 50 46.1 Hazard ratio for disease 40 33.2 progression or death, 30 0.65 (95% CI, 0.50-0.85) Sunvozertinib P<0.001 20 26.7 Chemotherapy 10 17.1 0 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization No. at Risk Sunvozertinib 163 143 108 74 60 48 34 26 18 9 3 0 Chemotherapy 161 128 84 51 28 22 14 7 6 2 1 0 --- Table 2. Key Efficacy End Points.* Sunvozertinib Chemotherapy Treatment Effect End Point (N=163) (N=161) (95% CI)T P Value Progression-free survival Median (95% CI) - mo 10.3 (8.3-14.0) 7.5 (6.7-8.5) 0.65 (0.50-0.85) <0.001 Percentage of patients (95% CI) At 12 mo 46.1 (37.9-53.9) 26.7 (19.3-34.6) NA NA At 18 mo 33.2 (25.3-41.3) 17.1 (10.7-24.7) NA NA At 24 mo 23.0 (15.8-31.0) 10.3 (5.1-17.6) NA NA Objective response:- Percentage of patients (95% CI) 58.9 (50.9-66.5) 31.1 (24.0-38.8) 3.2 (2.0-5.0) NA Duration of response Median (95% CI) - mo 11.2 (8.2-13.9) 7.1 (6.9-11.1) NA NA Overall survival Median (95% CI) — mo 29.8 (21.8-NE) 28.8 (20.7-NE) 0.99 (0.70-1.40) 0.48 Percentage of patients (95% CI) At 18 mo 65.5 (56.9-72.9) 67.2 (58.4-74.5) NA NA At 24 mo 57.4 (48.3-65.4) 56.2 (46.9-64.5) NA NA At 30 mo 50.0 (39.4-59.6) 49.1 (39.4-58.1) NA NA * The efficacy population included all the patients who had undergone randomization. NA denotes not applicable, and NE could not be estimated. t The treatment effect is shown as a hazard ratio for progression-free survival and overall survival and as an odds ratio for objective response. # Progression-free survival and objective response were assessed by blinded independent central review. --- Drug Sponsor Study ID Treatment regimen Enrollment Primary Status endpoint Scope Furmonertinib 240 mg (oral) FURVENT / Furmonertinib R Recruitment Allist NCT05607550 N=375 Furmonertinib 160 mg (oral) 375 PFS 1:1:1 completed International Platinum-based chemotherapy (IV) WU-KONG 28 / Sunvozertinib (oral) Dizal R Primary readout Sunvozertinib N=320 320 PFS NCT05668988 International 1:1 expected in 2026 Platinum-based chemotherapy (IV) PLB1004 (oral) Andamertinib Avistone NCT06281964 N=327 R 327 PFS Active, recruiting China only (PLB1004) 1:1 Platinum-based chemotherapy (IV) ± sintilimab (IV) Zipalertinib (oral) + Taiho / R Platinum-based chemotherapy (IV) Zipalertinib NCT05973773 N=260 260 PFS Active, recruiting International Cullinan 1:1 Chemotherapy (IV) YK-029A (oral) Suzhou CTR20230490/ R N=350 350 PFS YK-029A Recruiting China only Puhe NCT05767892 1:1 Platinum-based chemotherapy (IV) JMT101 (oral) + osimertinib (oral) Shanghai CTR20241252/ R JMT101 N=398 398 PFS Active, recruiting China only JMT-Bio NCT06380348 1:1 Cisplatin (IV) + pemetrexed (IV) Experimental arm Control arm IV: Intravenous PFS: Progression-free survival R Randomization --- Sequential treatment in the future? Chemotherapy + Amivantamab EGFR ex20ins TKI ADC +/- EGFR ex20ins TKI EGFR ex20ins TKI Chemotherapy + ADC +/- EGFR ex20ins TKI Amivantamab EGFR ex20ins TKI + Amivantamab ADC +/- EGFR ex20ins TKI Chemotherapy Amivantamab + Chemotherapy +/- EGFR ADC +/- EGFR ex20ins TKI EGFR ex20ins TKI ??? ex20ins TKI
Hidehito HORINOUCHI
Hidehito HORINOUCHI @HHorinouchi
#ASCO26 · May 29, 2026
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WU-KONG28 Study Design 202 ANN Sunvozertinib (300 mg, once daily, orally) Key Eligibility Criteria Cytologically/histogicall confirmed locally advanced or Randomized at 1:1 metastatic non-sq NSCLC Stratified by baseline Documented EGFR exon20ins brain metastasis (Y/N) Newly diagnosed or treatment naïve Platinum-based Chemotherapy ECOG: 0 or 1 (Carboplatin, AUC5 + pemetrexed, 500 Sunvozertinib PD mg/m2, Q3W up to 6 cycles, followed by (300 mg, once Primary Endpoint: pemetrexed maintenance therapy). daily, orally) PFS assessed by BICR a intravenous infusion Secondary Endpoints: OS (Key secondary) Crossover to sunvozertinib was allowed PFS assessed by investigator upon BICR-confirmed progressive disease ORR, DCR, DoR, and tumor size change Safety, Pharmacokinetics Exploratory Endpoints: PFS2 etc. for analysis: January 16, 2026; Abbreviation: AUC, Area Under Curve; BICR, Blinded Independent Central Non-small Review; Cell DCR, Lung Disease Cancer; Contral ORR, Objective Rate; DoR, Response Duration of Rate: Response; OS, Overall ECOG, Survival; Eastern PFS, Co- Data cut-off date primary EGFR, Epidermal Growth Factor Receptor; Exon20ins, Exon 20 Insertion Mutations; PFS2 is NSCLC, defined as the time from randomization to objective tumor progression on next line therapy based on operative Progression Oncology Free Survival; Group; PFS2, Second Progression Free Survival; QD, Once Daily; Q3W, Every 3 Weeks; I investigator Tumor assessment was conducted per RECIST 1.1 every 6 weeks in the first year and 12 weeks thereafter. assessment or death from any cause, whichever comes first. 4 0 OS follow-up was conducted every 3 months. ASCO - - PRESENTED BY: Dr. John V. Heymach, MD, PhD KNOWLEDGE CONQUERS CANCER ASCO #ASCO26 Presentation 5 property of the author and ASCO Permission required for revse, contact permissions@asong AL MEETING 2026ASCO ANNUAL MEETING ASCO ASCO --- Primary Endpoint: BICR-assessed PFS 202 ANN 100 Median Hazard Ratio P Value 90 (95% CI) (95% CI) 80 Sunvozertinib 10.3 (8.3, 14.0) 0.65 (0.50, 0.85) 0.0008 Chemotherapy 7.5 (6.7,8.5) Percentage of Patients 70 60 46.1% 50 33.2% 40 Sunvozertinib 30 26.7% 20 17.1% Chemotherapy 10 0 18 21 24 27 30 33 0 3 6 9 12 15 Months since Randomization Number At Risk: 26 18 9 3 0 48 34 74 60 108 7 6 2 1 0 Sunvozertinib 163 143 28 22 14 84 51 Chemotherapy 161 128 6 Median follow-up time: 24.0 months in the sunvozertinib arm and 18.0 months in the chemotherapy arm. KNOWLEDGE ASCO CONQUERS CANCER - CINCA $400,000 2026 ASCO #ASCO26 PRESENTED Presentation is property of the author and ASCO. Permission required for neuse, contact permissions@asce.org BT: Dr. John V. Heymach, MD, PhD AL MEETING 2026ASCO ASCO ANNUAL MEETING ASCO ASCO O --- BICR-assessed Tumor Response 2020 100 80 Sunvozertinib Armª Partial Response 100 ANN Stable Disease Partal Persponse Progressive Deease 80 Chemotherapy Arm State Doease 60 Not Evaluable Progressive Doease 60 Not Evaluable Best Tumor Change from Baseline (%) 40 40 20 20 0 0 -20 -20 40 40 -60 -60 -80 cORR: 58.9% -80 CORR: 31.1% Median tumor size shrinkage: 42.1% -100 -100 Median tumor size shrinkage: 24.7% Sunvozertinib (N=163) Chemotherapy (N=161) Best Objective Response Rate, % (95% CI) 68.1 (60.4,75.2) 35.4 (28.0,43,3) Confirmed Objective Response Rate, % (95% CI) 58.9(50.9,66.5) 31.1 (24.0, 38.8) Odds Ratio (95% CI); P value 3.2 (2.0, 5.0); P<0.0001 Disease Control Rate, % (95% CI) 94.5 (89.8,97.4) 85.7 (79.3,90.7) Calculated in patients with measurable target lesions at baseline assessed by BICR, including 158 patients in the sunvozertinib arm and 154 patients in the chemotherapy am. 8 2026 ASCO PRE SENTED BY: Dr. John V. Heymach, MD, PhD #ASCO26 ASCO CINICAL ONCOLOGY AL MEETING Presentation is property of the author and ASCO. Permission required for чи, contact permissions@asco org KNOWLEDGE CONQUERS CANCER --- Second Progression Free Survival (PFS2) 2026ASC ANNUAL MEET 100 Median Hazard Ratio P Value 90 (95% CI) (95% CI) 80 Sunvozertinib 21.7 (16.1, 24.3) 0.70 (0.52, 0.95) 0.0111 73.6% Chemotherapy 15.5 (13.4, 18.6) 70 Percentage of Patients 67.8% 60 55.8% First subsequent systemic therapy 50 Sunvozertinib arm 40 44.0% Sunvozertinib 46.6% (76/163) started subsequent therapy 30 72.4% (55/76) received chemotherapy 20 Chemotherapy Chemotherapy arm 10 72.0% (116/161) started subsequent therapy 0 91.4% (106ª/116) received sunvozertinib 0 3 6 9 12 15 18 21 24 27 30 33 36 (90.2% through in-study crossover) Months since Randomization Number At Risk: 157 142 116 95 77 60 49 31 16 11 2 0 Sunvozertinib 163 153 142 117 83 60 46 31 24 13 6 1 0 Chemotherapy 161 time: 23.6 months in the sunvozertinib arm and 24.1 months in the chemotherapy arm. Median follow-up defined as the time from the date of randomization to the time of second disease progression or death, whichever comes outside first, of after the the study first subsequent anti-cancer therapy. 10 PFS2 a Including is 101 patients (90.2%) who received sunvozertinib via in-study crossover and 5 patients who received sunvozertinib ASCO MOIOR CINCE INCOLOGY PRE SENTED BY: Dr. John V. Heymach, MD, PhD 2026 ASCO ENOWLEDGE CONQUERS CANCER #ASCO26 Presentation property of he author and ASCO. Permission required for reuse, contact permissions@asco.org AL MEETING 2026ASCO ANNUAL MEETING ASCO ASCO
UT MD Anderson
UT MD Anderson @UTMDAnderson
#ASCO26 · May 29, 2026
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O 2026 ASCO NG ANNUAL MEETING Sunvozertinib Monotherapy versus Platinum-based Chemotherapy as First-line Treatment for Advanced NSCLC with EGFR Exon20ins: Primary Analysis of A Multinational Phase 3 Randomized Study (WU-KONG28) John V. Heymach1, Geoffrey Liu², Ligang Xing³, Laurent Greiller', John Thomas⁵, Ozan Yazic/5, Meil Sun Yun Fan*, Chengzhi Zhou Mengzhao Wang Regan M Memmott Dariusz Kowalski¹, Catherine Shu¹³, Elaine Shum14, Elvire Pons-Tostivint Federica Bertolini Gonzalo Fernandez Hinojan Lorenzo Antonuzzo¹⁸, Yiman Wang", Calcun Zhou Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, the USA Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada; Department of Radution Ononiogy, Shandong Cancer Hospital and institute, Jhan, China, "Department of Multidisciplinary Oncology and Therapeutic Innovations, Assistance Publique-Höpitaux de Marselle, Ax Marseile University, Marseille, France, Department of Medical Oncology, Peter MacCalium Cancer Centre, Melbourne, Australia; Department of Medical Oncology, Gazi University Hospital, Arkara, Turkey, Department of Oncology, Jinan Central Hospital, Shandong University, Jhan, China, Department of Thoracic Medical Oncology, Zhejang Cancer Hospital, Hangzhou, China; Department of Oncology, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, "Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Beijing, China; "Department of Internal Medicine, The Ohio State University James Comprehensive Cancer Center, Columbus, OM, the USA Department USA; Division of Medical Oncology and Hematology, Perimuter Cancer Center, NYU Langone Health, New York, NY, the USA, "Department of Medical Oncology, Nantes University Hospital, Nantes, France of Lung Cancer and Thoracic Tumors, Maria Sklodowska-Curie National Research institute of Onoology, Warsaw, Poland, "Department of Medicine, Columbia University inving Medical Center, New York, NY, the "Division of Oncology, Department of Oncology and Hematology, Modena University Hospital, Modena, Italy, "Department of Medical Onoology, Clinica Universidad de Navama, Madrid, Spain; "Department of of Experimental and Clinical Medicine, University of Florence, and the Medical Oncology Unit Careggi University Hospital, Florence, italy, "Dizal (Jangsu) Pharmaceutical Co. Ltd. Shanghai, China POepartment Oncology, Shanghai Pulmonary Hospital; Shanghai East Hospital, Shanghai, China PAL SENTED BY: Dr. John V. Heymach, MD, PhD ASCO 2026 ASCO #ASCO26 KNOWLEDGE COMQUARA CANCER ANNUAL MEETING I importy author and ASCO Person 2026ASCO A ANNUAL MEETING A ASCO ASCO ASCO ASCO ASCO ASCO ASCO A ASCO ASCO ASCO ASCO ASCO ASCO ASCO A ASCO ASC ASCO ASCO ASCO ASCO --- CO Key Takeaways EETING EFFICACY SAFETY Sunvozertinib vs Chemotherapy Sunvozertinib WU-KONG28 met its primary endpoint: statistically significant Safety profile similar to previous and clinically meaningful PFS improvement with sunvozertinib reports and manageable Improved ORR and prolonged DoR with sunvozertinib No new safety signals 2 2026 ASCO ASCO26 PRESENTED BY Dr. John V. Heymach, MD, PhD ASCO ANNUAL MEETING - - - and ABOD - - - ENGWLEDGE CONDUERS CANCER 2026ASCO ANNUAL MEETING ASCO ASCO ASCO ASCO ASCO ASCO ASCO ASCO ASCO ASCO AS A ASCO ASCO ASCO ASCO ASCO
ilyas sahin, MD
ilyas sahin, MD @ilyassahinMD
#ASCO26 · May 29, 2026
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100 Median 90 Progression-free Survival 80 (95% CI) 70 mo Percentage of Patients 60 Sunvozertinib 10.3 (8.3-14.0) Chemotherapy 7.5 (6.7-8.5) 50 46.1 Hazard ratio for disease 40 33.2 progression or death, 30 0.65 (95% CI, 0.50-0.85) Sunvozertinib P<0.001 20 26.7 Chemotherapy 10 17.1 0 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization No. at Risk Sunvozertinib 163 143 108 74 60 48 34 26 18 9 3 0 Chemotherapy 161 128 84 51 28 22 14 7 6 2 1 0
Ana I. Velázquez Mañana, MD, MSc, FASCO
#ASCO26 · May 29, 2026
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The NEW ENGLAND JOURNAL of MEDICINE ORIGINAL ARTICLE First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations Caicun Zhou,¹ L. Greillier,² G. Liu,³ T. John,⁴ L. Xing,⁵ D. Kowalski,6 R.M. Memmott,⁷ O. Yazici,⁸ M. Sun,⁹ C. Shu, 10 E. Pons-Tostivint, 11 Y. Fan, 12 G. Fernandez-Hinojal, 13 E. Shum,¹ 14 M. Wang, 15 F. Bertolini, 16 D.R. Camidge,¹⁷ Chengzhi Zhou, 18 L. Doucet, 19 Q. Hong, J. Fang,²¹ D. Huang, 22 B. Jin, Y. Yu, 24 L. Antonuzzo,²⁵ D. Moro-Sibilot, J. Bennouna, 27 G. de Castro, Jr., 28 L. Zheng,²⁹ and J.V. Heymach,30 for the WU-KONG28 Investigators* 100 Median 90 Progression-free Survival 80 (95% CI) 70 mo Percentage of Patients 60 Sunvozertinib 10.3 (8.3-14.0) Chemotherapy 7.5 (6.7-8.5) 50 46.1 Hazard ratio for disease 40 33.2 progression or death, 30 0.65 (95% CI, 0.50-0.85) Sunvozertinib P<0.001 20 26.7 Chemotherapy 10 17.1 0 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization No. at Risk Sunvozertinib 163 143 108 74 60 48 34 26 18 9 3 0 Chemotherapy 161 128 84 51 28 22 14 7 6 2 1 0 Figure 1. Progression-free Survival. Shown are Kaplan-Meier estimates of progression-free survival as assessed by blinded independent central review in the efficacy population, which included all the patients who had undergone randomization. The tick marks indi- cate censoring of data.
Dr. Antonio Calles 🫁🚭
#ASCO26 · May 29, 2026
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WU-KONG28 Study Design Sunvozertinib (300 mg, once daily, orally) Key Eligibility Criteria Cytologically/histologically confirmed locally advanced or Randomized at 1:1 metastatic non-sq NSCLC Stratified by baseline Documented EGFR exon20ins brain metastasis (Y/N) Newly diagnosed or treatment naïve Platinum-based Chemotherapy ECOG: 0 or 1 (Carboplatin, AUC5 + pemetrexed, 500 Sunvozertinib PD mg/m2, Q3W up to 6 cycles, followed by (300 mg, once Primary Endpoint: pemetrexed maintenance therapy), daily, orally) PFS assessed by BICR a intravenous infusion Secondary Endpoints: OS (Key secondary) Crossover to sunvozertinib was allowed PFS assessed by investigator a upon BICR-confirmed progressive disease ORR, DCR, DoR, and tumor size change Safety, Pharmacokinetics Exploratory Endpoints: PFS2 etc. Data cut-off date for primary analysis: January 16, 2026; Abbreviation: AUC, Area Under Curve; BICR, Blinded Independent Central Review; DCR, Disease Contral Rate; DoR, Duration of Response; ECOG, Eastern Co- operative Oncology Group; EGFR, Epidermal Growth Factor Receptor; Exon20ins, Exon 20 Insertion Mutations; NSCLC, Non-small Cell Lung Cancer; ORR, Objective Response Rate; OS, Overall Survival; PFS, Progression Free Survival; PFS2, Second Progression Free Survival; QD, Once Daily; Q3W, Every 3 Weeks; PFS2 is defined as the time from randomization to objective tumor progression on next line therapy based on Investigator assessment or death from any cause, whichever comes first. a Tumor assessment was conducted per RECIST 1.1 every 6 weeks In the first year and 12 weeks thereafter. 4 b OS follow-up was conducted every 3 months. 2026 ASCO PRESENTED BY: Dr. John V. Heymach, MD, PhD #ASCO26 ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse; contact permissions@asco.org KNOWLEDGE CONQUERS CANCER --- Primary Endpoint: BICR-assessed PFS 100 Median Hazard Ratio P Value 90 (95% CI) (95% CI) 80 Sunvozertinib 10.3 (8.3, 14.0) 0.65 (0.50, 0.85) 0.0008 Percentage of Patients 70 Chemotherapy 7.5 (6.7, 8.5) 60 50 46.1% 40 33.2% 30 Sunvozertinib 20 26.7% 10 17.1% 0 Chemotherapy 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization Number At Risk: Sunvozertinib 163 143 108 74 60 48 34 26 18 9 3 0 Chemotherapy 161 128 84 51 28 22 14 7 6 2 1 0 Median follow-up time: 24.0 months in the sunvozertinib arm and 18.0 months In the chemotherapy arm. 6 2026 ASCO PRESENTED BY: Dr. John V. Heymach, MD, PhD #ASCO26 ASCO AMERICAN SOCIETY OF ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse; contact permissions@asco.or CLINICAL ONCOLOGY KNOWLEDGE CONQUERS CANCER --- Subgroup Analysis of BICR-assessed PFS Subgroup No. of Events/Patients Hazard Ratio(95%CI) Sunvozertinib Chemotherapy Overall 111/163 115/161 0.65 (0.50, 0.85) Age Group <65 years 66/89 71/93 0.62 (0.44, 0.87) >65 years 45/74 44/68 0.71 (0.46, 1.07) Sex Female 54/87 70/105 0.68 (0.48, 0.97) Male 57/76 45/56 0.58 (0.39,0.85) Race Asian 77/102 79/102 0.56 (0.41, 0.77) Non-Asian 34/61 36/59 0.93 (0.58,1.48) Region North America EU 27/50 33/52 0.78 (0.47, 1.30) Others 84/113 82/109 0.62 (0.45,0.84) Smoking History Never 64/101 74/107 0.61 (0.43,0.85) Ever 47/62 41/54 0.73 (0.48,1.11) Baseline ECOG 0 28/46 26/43 0.77 (0.45,1.31) >1 83/117 89/118 0.62 (0.46,0.84) Brain Metastasis at Baseline With 14/21 12/20 0.96 (0.44, 2.08) Without 97/142 103/141 0.62 (0.47,0.83) EGFR Exon20ins Subtype 769 ASV 34/51 39/52 0.46 (0.29,0.73) 770_SVD 15/21 19/32 Other/Unknown 62/91 57/77 0.77 (0.53,1.10) EGFR Exon20ins Region Near loop 77/111 79/109 0.59(0.43,0.82) Far loop 28/41 30/43 0.83 (0.49, 1.38) C-helix/Unknown 6/11 6/9 Disease Related Surgery With 21/34 19/31 0.55 (0.29, 1.02) Without 90/129 96/130 0.69 (0.51,0.92) 0.2 1 2 4.5 Favors Sunvozertinib Favors Chemotherapy 7 2026 ASCO PRE SENTED BY: Dr. John V. Heymach, MD, PhD #ASCO26 ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse: contact permissions@asco.or KNOWLEDGE CONQUERS CANCER --- Interim Analysis of Overall Survival 100 Median 90 (95% CI) Sunvozertinib 29.8 (21.8, NE) 80 Chemotherapy 28.8 (20.7, NE) 70 Percentage of Patients 60 Sunvozertinib os data maturity 50 38.9% (126/324) 40 Chemotherapy 38.0% (62/163) in the sunvozertinib arm 30 39.8% (64/161) in the chemotherapy arm 20 In-study crossover 10 90.2% (101/112) patients with BICR- 0 confirmed progressive disease crossed 0 3 6 9 12 15 18 21 24 27 30 33 36 39 over to receive sunvozertinib treatment Months since Randomization Number At Risk: Sunvozertinib 163 158 149 132 108 92 76 67 60 40 21 8 2 0 Chemotherapy 161 154 147 134 113 97 79 62 55 40 24 10 2 0 Median follow-up time: 26.1 months in the sunvozertinib arm and 26.7 months in the chemotherapy arm. 11 2026 ASCO PRE SENTED BY: Dr. John V. Heymach, MD, PhD #ASCO26 ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco.org KNOWLEDGE CONQUERS CANCER
Chul Kim
Chul Kim @chulkimMD
#ASCO26 · May 29, 2026
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Primary Endpoint: BICR-assessed PFS 100 Median Hazard Ratio P Value 90 (95% CI) (95% CI) 80 Sunvozertinib 10.3 (8.3, 14.0) 0.65 (0.50, 0.85) 0.0008 Percentage of Patients 70 Chemotherapy 7.5 (6.7, 8.5) 60 50 46.1% 40 33.2% 30 Sunvozertinlb 20 26.7% 17.1% 10 Chemotherapy 0 0 3 6 9 12 15 18 21 24 27 30 33 Months since Randomization Number At Risk: Sunvozertinib 163 143 108 74 60 48 34 26 18 9 3 0 Chemotherapy 161 128 84 51 28 22 14 7 6 2 1 0 Median follow-up time: 24.0 months in the sunvozertinib arm and 18.0 months in the chemotherapy arm. 6 2026 ASCO PRE SENTED BY: Dr. John V. Heymach, MD, PhD #ASCO26 ASCO AMERICAN SOCIETY OF CUNICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse, contact permissions@asco.org org. KNOWLEDGE CONQUERS CANCER --- BICR-assessed Tumor Response Partial Response 100 Stable Disease Partial Response Chemotherapy Armᵃ Progressive Disease 100 Stable Disease 80 Not Evaluable Sunvozertinib Armᵃ Progressive Disease 80 Not Evaluable 60 60 40 Best Tumor Change from Baseline (%) 40 20 20 0 0 -20 -20 -40 -40 -60 -60 cORR: 31.1% cORR: 58.9% -80 -80 Median tumor size shrinkage: 24.7% Median tumor size shrinkage: 42.1% -100 -100 Sunvozertinib (N=163) Chemotherapy (N=161) Best Objective Response Rate, % (95% CI) 68.1 (60.4, 75.2) 35.4 (28.0, 43.3) Confirmed Objective Response Rate, % (95% CI) 58.9 (50.9, 66.5) 31.1 (24.0, 38.8) Odds Ratio (95% CI); P value 3.2 (2.0, 5.0); P<0.0001 Disease Control Rate, % (95% CI) 94.5 (89.8, 97.4) 85.7 (79.3, 90.7) Calculated in patients with measurable target lesions at baseline assessed by BICR, including 158 patients in the sunvozertinib arm and 154 patients in the chemotherapy arm. 8 ASCO #ASCO26 PRE SENTED BT: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY --- Second Progression Free Survival (PFS2) 100 Median Hazard Ratio P Value 90 (95% CI) (95% CI) 80 Sunvozertinib 21.7 (16.1, 24.3) 0.70 (0.52, 0.95) 0.0111 73.6% Chemotherapy 15.5 (13.4, 18.6) 70 Percentage of Patients 67.8% 60 55.8% First subsequent systemic therapy 50 Sunvozertinib arm 40 44.0% Sunvozertinib 46.6% (76/163) started subsequent therapy 30 72.4% (55/76) received chemotherapy 20 Chemotherapy Chemotherapy arm 10 72.0% (116/161) started subsequent therapy 0 0 3 6 9 12 15 18 21 24 27 30 33 36 91.4% (106a/116) received sunvozertinib (90.2% through in-study crossover) Months since Randomization Number At Risk: Sunvozertinib 163 157 142 116 95 77 60 49 31 16 11 2 0 Chemotherapy 161 153 142 117 83 60 46 31 24 13 6 1 0 Median follow-up time: 23.6 months in the sunvozertinib arm and 24.1 months in the chemotherapy arm. PFS2 is defined as the time from the date of randomization to the time of second disease progression or death, whichever comes first, after the first subsequent anti-cancer therapy. a Including 101 patients (90.2%) who received sunvozertinib via in-study crossover and 5 patients who received sunvozertinib outside of the study 10 2026 ASCO #ASCO26 PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse; contact permissions@asco.org. KNOWLEDGE CONQUERS CANCER --- Subsequent Treatment Sunvozertinib Arm Chemotherapy Arm 100 100 90 90 80 80 70 57.8 63.9 64.5 70 1 line 73.0 With 1 line 60 Discontinued 60 84.5 85.3 Patients (%) 50 Patients (%) Discontinued With 50 40 40 30 30 23.3 2 lines 25.0 20 36.1 2 lines 20 27.0 Without 10 Ongoing 10 15.5 10.5 14.7 19.0 Ongoing Without >3 lines 23 lines 0 0 Sunvozertinib Subsequent Therapy Lines of Subsequent Therapy Chemotherapy Subsequent Therapy Lines of Subsequent Therapy (N=163) (N=119) (N=76) (N=161) (N=136) (N=116) Types of subsequent therapies included amivantamab, antiangiogenic therapy, chemotherapy, immunotherapy, targeted therapy (e.g., sunvozertinib and other EGFR TKI) and Other 12 2026 ASCO #ASCO26 PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY OF ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse, contact permissions@asco.org org. CLINICAL ONCOLOGY KNOWLEDGE CONQUERS CANCER
Dr Rishabh Jain
Dr Rishabh Jain @DrRishabhOnco
#ASCO26 · May 29, 2026
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Therapeutic advances in EGFR ex20 ins mutations EXCLAIM EXCLAIM-2 Accelerated approval Mobocertinib vs mobocertinib Chemo Structural basis PFS:9.6v9.6m resistance to 1G Tmi (months) EGFR TKI in Ex20 CHRYSALIS insertions Accelerated approval Roubichoux et al. WU-KONG 1B Yasuda STM 2013 - amivantamab Structural-functional Accelerated approval (monotherapy) basis classification Sunvozertinib 200 mg 2013 2015 2017 2019 2021 2023 2024 2025 2026 Yang et al. Role of Osimertinib 160 mg OM PAPILLON FAVOUR WU-KONG 28 afatinib in uncommon POSITION20 SoC chemo- Firmonertinib Phase III mutations (LUX-2, ORR 28% mPFS 6.8 m amivantamab ORR 78.6% Sunvozertinib 300 mg LUX-3, LUX-6) ECOG ACRIN EA5162 mDoR 15.2 m vs chemo - 3 cohorts: Exon 20 ins/atypicals/ T790M ORR 24%, mPFS 9.6 m Limited efficacy for / - afatinib in exon 20 ins 2026 ASCO #ASCO26 PRESENTED BY: Daniel SW Tan. National Cancer Centre Singapore ASCO AMERICAN SOCIETY O CUNICAL ONCOLOGY ANNUAL MEETING Presentation property of the author and ASCO Permission required for num KNOWLEDGE CONQUERS CANCER
Balazs Halmos
Balazs Halmos @BalazsHalmosMD
#ASCO26 · May 29, 2026
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WU-KONG28 Study Design Sunvozertinib Key Eligibility Criteria (300 mg, once daily, orally) Cytologically/histogicall confirmed locally advanced or Randomized at 1:1 metastatic non-sq NSCLC Stratified by baseline Documented EGFR exon20ins brain metastasis (Y/N) Newly diagnosed or treatment naive ECOG: 0 or 1 Platinum-based Chemotherapy (Carboplatin, AUC5 + pemetrexed, 500 Sunvozertinib PD mg/m2, Q3W up to 6 cycles, followed by Primary Endpoint: (300 mg, once PFS assessed by BICR a pemetrexed maintenance therapy). daily, orally) intravenous infusion Secondary Endpoints: OS (Key secondary) b Crossover to sunvozertinib was allowed PFS assessed by investigator ᵃ upon BICR-confirmed progressive disease ORR, DCR, DoR, and tumor size change Safety, Pharmacokinetics Exploratory Endpoints: PFS2 etc. Data cut-off date for primary analysis: January 16, 2026; Abbreviation: AUC, Area Under Curve; BICR, Blinded Independent Central Review; DCR, Disease Contral Rate; DoR, Duration of Response; ECOG, Eastern Co- operative Oncology Group; EGFR, Epidermal Growth Factor Receptor; Exon20ins, Exon 20 Insertion Mutations; NSCLC, Non-small Cell Lung Cancer; ORR, Objective Response Rate; os, Overall Survival; PFS, Progression Free Survival; PFS2, Second Progression Free Survival; QD, Once Daily; Q3W, Every 3 Weeks; PFS2 is defined as the time from randomization to objective tumor progression on next line therapy based on investigator assessment or death from any cause, whichever comes first. a Tumor assessment was conducted per RECIST 1.1 every 6 weeks in the first year and 12 weeks thereafter. b OS follow-up was conducted every 3 months. PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN CUNICAL 2026 ASCO #ASCO26 KNOWLEDGE CONQUERS NNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco.org --- Second Progression Free Survival (PFS2) 100 Median Hazard Ratio P Value 90 (95% CI) (95% CI) 80 Sunvozertinib 21.7 (16.1, 24.3) 0.70 (0.52, 0.95) 0.0111 73.6% Chemotherapy 15.5 (13.4, 18.6) 70 Percentage of Patients 67.8% 60 55.8% First subsequent systemic therapy 50 Sunvozertinib arm 40 44.0% Sunvozertinib 46.6% (76/163) started subsequent therapy 30 72.4% (55/76) received chemotherapy 20 Chemotherapy Chemotherapy arm 10 72.0% (116/161) started subsequent therapy 0 9 12 15 18 21 24 27 30 33 36 91.4% (106a/116) received sunvozertinib 0 3 6 (90.2% through in-study crossover) Months since Randomization Number At Risk: Sunvozertinib 163 157 142 116 95 77 60 49 31 16 11 2 0 Chemotherapy 161 153 142 117 83 60 46 31 24 13 6 1 0 Median follow-up time: 23.6 months in the sunvozertinib arm and 24.1 months in the chemotherapy arm. PFS2 is defined as the time from the date of randomization to the time of second disease progression or death, whichever comes first, after the first subsequent anti-cancer therapy 10 a Including 101 patients (90.2%) who received sunvozertinib via in-study crossover and 5 patients who received sunvozertinib outside of the study 2026 ASCO PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY of CUMICAL OHCOLOGY #ASCO26 ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse, contact permissions@asco.org. KNOWLEDGE CONQUERS CANCER --- Overview of Safety Sunvozertinib Chemotherapy (N=163)ᵃ (N=150)ᵃ Participants with Any TRAE 163 (100.0) 146 (97.3) Any TRAE with Grade ≥3 100 (61.3) 74 (49.3) Any Treatment-related SAE 30 (18.4) 19 (12.7) Any TRAE Leading to Dose Interruption 74 (45.4) 41 (27.3) Any TRAE Leading to Dose Reduction 66 (40.5) 36 (24.0) Any TRAE Leading to Treatment Discontinuation 12 (7.4) 17 (11.3) Any TRAE with Fatal Outcome 0 (0.0) 1 (0.7)b In the sunvozertinib arm, the top TRAEs leading to dose interruption and reduction included blood CPK increased and diarrhea, which did not lead to treatment discontinuation. Abbreviation: SAE, Serious Adverse Event; TRAE, Treatment-related Adverse Event. TRAEs included any events considered as related to the randomized treatment. a only included patients who received randomized treatment; b The drug-related TEAE with fatal outcome in the chemotherapy arm was pneumonia. 13 2026 ASCO #ASCO26 PRESENTED BY: Dr. John V. Heymach, MD, PhD ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse, contact permissions@asco.org ASCO AMERICAN GOCETY OF CLINICAL CHICOLOGE KNOWLEDGE CONQUERS CANCER
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
#ASCO26 · May 29, 2026
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Overview of Safety Sunvozertinib Chemotherapy (N=163)ᵃ (N=150)a Participants with Any TRAE 163 (100.0) 146 (97.3) Any TRAE with Grade ≥3 100 (61.3) 74 (49.3) Any Treatment-related SAE 30 (18.4) 19 (12.7) Any TRAE Leading to Dose Interruption 74 (45.4) 41 (27.3) Any TRAE Leading to Dose Reduction 66 (40.5) 36 (24.0) Any TRAE Leading to Treatment Discontinuation 12 (7.4) 17 (11.3) Any TRAE with Fatal Outcome 0 (0.0) 1 (0.7)b In the sunvozertinib arm, the top TRAEs leading to dose interruption and reduction included blood CPK increased and diarrhea, which did not lead to treatment discontinuation. Abbreviation: SAE, Serious Adverse Event; TRAE, Treatment-related Adverse Event. TRAEs included any events considered as related to the randomized treatment. 13 a only included patients who received randomized treatment; b The drug-related TEAE with fatal outcome in the chemotherapy arm was pneumonia. 2026 ASCO #ASCO26 PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY OF CUNICAL ONCOLOGY ANNUAL MEETING Presentation KNOWL EDGE CONQUERS ANCER --- Common Treatment-related Adverse Events (≥ 20%) Sunvozertinib (N=163) Chemotherapy (N=150) All Grade ≥ Grade 3 All Grade ≥ Grade 3 Participants with Any TRAE 163 (100.0) 100 (61.3) 146 (97.3) 74 (49.3) Diarrhea 137 (84.0) 22 (13.5) 15 (10.0) 0 (0.0) Blood creatine phosphokinase increased 90 (55.2) 33 (20.2) 5 (3.3) 1 (0.7) Rash 84 (51.5) 1 (0.6) 8 (5.3) 0 (0.0) Paronychia 79 (48.5) 6 (3.7) 0 (0.0) 0 (0.0) Anemia 75 (46.0) 10 (6.1) 91 (60.7) 15 (10.0) Weight decreased 56 (34.4) 5 (3.1) 15 (10.0) 1 (0.7) Decreased appetite 52 (31.9) 1 (0.6) 39 (26.0) 2 (1.3) Blood creatinine increased 50 (30.7) 1 (0.6) 12 (8.0) 0 (0.0) Vomiting 40 (24.5) 3 (1.8) 32 (21.3) 3 (2.0) Nausea 38 (23.3) 3 (1.8) 66 (44.0) 2 (1.3) Aspartate aminotransferase increased 35 (21.5) 3 (1.8) 52 (34.7) 1 (0.7) Lipase increased 35 (21.5) 9 (5.5) 8 (5.3) 1 (0.7) Amylase increased 34 (20.9) 2 (1.2) 11 (7.3) 0 (0.0) Alanine aminotransferase increased 25 (15.3) 2 (1.2) 50 (33.3) 2 (1.3) Neutrophil count decreased 22 (13.5) 4 (2.5) 68 (45.3) 28 (18.7) White blood cell count decreased 20 (12.3) 1 (0.6) 58 (38.7) 10 (6.7) Platelet count decreased 11 (6.7) 2 (1.2) 32 (21.3) 10 (6.7) Constipation 4 (2.5) 0 (0.0) 30 (20.0) 0 (0.0) 14 2026 ASCO #ASCO26 PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco.org KNOWLEDGE CONQUERS CANCER --- Conclusion In the primary analysis of WU-KONG28 study, sunvozertinib demonstrated significantly superior anti- tumor efficacy than platinum-containing chemo doublet in 1L advanced NSCLC patients with EGFR exon20ins: Statistically significant and clinically meaningful improvement in PFS (mPFS: 10.3 VS 7.5 months; HR: 0.65; P=0.0008) Higher ORR (58.9% VS 31.1%) and DCR (94.5% VS 85.7%), and longer DoR (11.2 VS 7.1 months) The OS data were immature (38.9% maturity). The PFS2 suggested a long-term survival benefit with sunvozertinib (21.7 months VS 15.5 months) The common TRAEs of sunvozertinib were related to wild-type EGFR inhibition and clinically manageable These results support sunvozertinib as first-line treatment for NSCLC patients with EGFR exon20ins, with the advantage of a single oral agent 15 2026 ASCO PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCIETY OF #ASCO26 CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissiona@asco.org KNOWLEDGE CONQUERS CANCER
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
#ASCO26 · May 29, 2026
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Interim Analysis of Overall Survival 100 Median 90 (95% CI) Sunvozertinib 29.8 (21.8, NE) 80 Chemotherapy 28.8 (20.7, NE) 70 Percentage of Patients 60 Sunvozertinib OS data maturity 50 38.9% (126/324) 40 Chemotherapy 38.0% (62/163) in the sunvozertinib arm 30 39.8% (64/161) in the chemotherapy arm 20 In-study crossover 10 90.2% (101/112) patients with BICR- 0 confirmed progressive disease crossed 0 3 6 9 12 15 18 21 24 27 30 33 36 39 over to receive sunvozertinib treatment Months since Randomization Number At Risk: Sunvozerfinib 163 158 149 132 106 92 76 67 60 40 21 a 2 0 Chemotherapy 161 154 147 134 113 97 TO 62 55 40 24 10 2 0 Median follow-up time 26.1 months in the sunvozertinib arm and 26.7 months in the chemotherapy arm. 11 2026 ASCO #ASCO26 PRE SENTED BY: Dr. John V. Heymach, MD, PhD ASCO - OF CLARKEAL - ANNUAL MEETING Possentation - property of - - and ACCO Person required - - contact - KNOWLEDGE CONQUERS CANCER --- Subsequent Treatment Sunvozertinib Arm Chemotherapy Arm 100 100 90 90 80 80 57.8 70 63.9 64.5 70 1 line 73.0 With 1 line 60 Discontinued 60 84.5 85.3 Patients (%) Patients (%) Discontinued With 50 50 40 40 23.3 30 30 2 lines 25.0 20 36.1 2 lines 20 27.0 Without 10 Ongoing 10 19.0 15.5 14.7 10.5 Ongoing 23 lines Without >3 lines 0 0 Sunvozertinib Subsequent Therapy Lines of Subsequent Therapy Chemotherapy Subsequent Therapy Lines of Subsequent Therapy (N=163) (N=119) (N=76) (N=161) (N=136) (N=116) Types of subsequent therapies included amivantamab, antiangiogenic therapy, chemotherapy, immunotherapy, targeted therapy (e.g., sunvozertinib and other EGFR TKI) and Other 12 2026 ASCO #ASCO26 PRESENTED BY: Dr. John V. Heymach, MD, PhD ASCO AMERICAN SOCH CUNICAL ONCOL

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Eric K. Singhi, MD
Eric K. Singhi, MD @lungoncdoc
‼️ Phase 3 WU-KONG28: 1L Sunvozertinib v Chemotherapy in EGFR exon20 NSCLC ▫️mPFS 10.3 v 7.5 mos (HR 0.65) ▫️ORR ~60% v 30% Keep in mind, 1L PAPILLON (Amivantamab + chemo) is currently our SOC (mPFS 11.4 mos, ORR of 73%) #ASCO26 @ASCO https://t.co/oCkiYgrSuH
4,520 views 39 likes 23 RT 2026-05-29
Hidehito HORINOUCHI
Hidehito HORINOUCHI @hhorinouchi
🆙 @OncoAlert #ASCO26 #LCSM 🔝🔟Abstracts Leads: @HHorinouchi @UOzkerim @WeOncologists 1 HARMONi-6 2 LIBRETTO-432 3 WU-KONG28 4 OptiTROP-Lung05 5 TRITON 6 CROWN 7yr 7 LORIN 8 AcceleRET-Lung 9 Silevertinib 10 Concurrent CRT + durvalumab in ES-SCLC @ASCO @Larvol https://t.co/JUNcBp39Vo
2,823 views 45 likes 19 RT 2026-05-27
Masahiro TORASAWA, MD. PhD.
Masahiro TORASAWA, MD. PhD. @M_Torasawa
🫁 #ASCO26 prep ❶ #️⃣LBA8500 | WU-KONG28 (Ph3, multinational) ✨ First multinational Ph3 RCT of sunvozertinib (oral EGFR exon20 ins–selective TKI) vs platinum-based chemotherapy as 1L in advanced NSCLC with EGFR exon 20 ins mutations 📊 Primary analysis to be presented as LBA https://t.co/fuOYAPBW4q
2,580 views 10 likes 4 RT 2026-05-28
Dr Amol Akhade
Dr Amol Akhade @SuyogCancer
LBA8500: WU-KONG28 delivers a positive phase 3 result in EGFR exon20ins NSCLC. Sunvozertinib monotherapy improved PFS vs platinum/pemetrexed: • mPFS 10.3 vs 7.5 months • HR 0.65 (p=0.0008) • ORR 58.9% vs 31.1% • DoR 11.2 vs 7.1 months • 90% crossover to sunvozertinib after https://t.co/n45lBiaIsz
2,412 views 20 likes 10 RT 2026-05-29
Dr. Estela Rodriguez
Dr. Estela Rodriguez @Latinamd
And the concomitant #ASCO26 publications are out: #WU-KONG28 Ph3 trial of 1L #Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations ➡️ mPFS 10.3 vs 7.5 mos ⬆️ ORR 58.9% vs 31.1% ⚠️ AEs renal, GI, anemia 👎 FDA approved in July 2025 but not yet available in the US for https://t.co/gLoBx6Fpz6
2,042 views 19 likes 9 RT 2026-05-29
Dr Amol Akhade
Dr Amol Akhade @suyogcancer
Three ASCO 2026 Day 1 LBAs to watch closely: ( only 3 of them in adult solid tumors -too low for Day 1 ? ) @dr_yakupergun 1 - WU-KONG28: Sunvozertinib vs platinum chemotherapy in frontline EGFR exon20ins NSCLC. Sunvozertinib is a next-generation oral EGFR TKI designed https://t.co/0MbCtbsg6G
1,349 views 16 likes 4 RT 2026-05-28
Yakup Ergün
Yakup Ergün @dr_yakupergun
WU-KONG28 was published in @NEJM simultaneously with #ASCO26 In 1L EGFR exon20ins NSCLC, oral sunvozertinib showed: PFS 10.3 vs 7.5 mos HR 0.65 12-month PFS: 46.1% vs 26.7% ORR 58.9% vs 31.1% In PAPILLON, 12-month PFS with ami-chemo was approximately 48%. Sunvozertinib seems https://t.co/G5YegzzCqV
1,223 views 25 likes 10 RT 2026-05-29
Rami Manochakian MD, FASCO Cancer Education
Rami Manochakian MD, FASCO Cancer Education @RManochakian
🔥🚨@OncoAlert Hot off the press. Just published @NEJM in conjunction with presentation @ASCO #ASCO26 ⭐️Results of #WUKONG28 trial of: ✅#Sunvozertinib Vs #Chemotherapy For #1st line Tx of advanced #NSCLC with #EGFR #Exon20 insertion mutations. 👇🏻 https://t.co/2MSWJNq3DM https://t.co/7DbXMT4WMz
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Uğur Özkerim
Uğur Özkerim @UOzkerim
🧬✨ASCO26 starts tomorrow and the lung cancer🫁 program really looks packed this year📢 From HARMONi-6 and LIBRETTO-432 to WU-KONG28, perioperative ALK strategies and KRAS/STK11-focused IO approaches, there’s a lot of potentially impactful thoracic oncology data ahead. https://t.co/dVOYd3vctx
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Jordi Remon
Jordi Remon @JordiRemon
WUKONG28: 1st line sunvozertinib (300 mg) improved PFS vs CT in mNSCLC & EGFRex20ins. First positive trial. Qx🧐 -dose:200 or 300? FDA approved 200 in 2L. Toxicity! -TKI alone or TKI+CT specially for EGFR20ins far-loop? -Other trials ongoing, crowded space -Best sequence? #ASCO26 https://t.co/ai0i00vj5y
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Hidehito HORINOUCHI
Hidehito HORINOUCHI @HHorinouchi
🆙 #ASCO26 #LCSM Oral Abstract Session 🔥WU-KONG28: Sunvozertinib Monotherapy vs Platinum-Based Chemotherapy as First-Line Treatment for Advanced NSCLC with EGFR Exon20ins 🎙️Dr. John V. Heymach 🔢LBA8500 ☑️NCT05668988 🔗 https://t.co/xakJ6JI2Nk @OncoAlert @Larvol @ASCO @IASLC https://t.co/Xx6rJtGaT6
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UT MD Anderson
UT MD Anderson @UTMDAnderson
Phase 3 data presented by Dr. John Heymach at #ASCO26 show sunvozertinib significantly improved progression-free survival and response rates compared with chemotherapy as a first-line treatment for advanced NSCLC with EGFR exon20ins mutations. The findings support sunvozertinib https://t.co/pgYqAukvkj
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ilyas sahin, MD
ilyas sahin, MD @ilyassahinMD
WU-KONG28 in @NEJM and #ASCO26: First-line sunvozertinib beat chemo in advanced NSCLC with EGFR exon 20 insertions. PFS 10.3 vs 7.5 months (HR 0.65) Response rate 59% vs 31% (meaningful tumor shrinkage) Duration of response 11.2 vs 7.1 months An oral, chemo-free option for a https://t.co/qw0dWUAx1s
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Ana I. Velázquez Mañana, MD, MSc, FASCO
Ana I. Velázquez Mañana, MD, MSc, FASCO @AnaVManana
🫁 #ASCO26 #LungCancer WU-KONG28: 1L Sunvozertinib in EGFR exon20ins NSCLC Compared to carbo/pemetrexed, sunvozertinib improved: 🔹mPFS 10.3 vs 7.5 mo (HR 0.65; 95% CI, 0.50 to 0.85) 🔹12mo PFS: 46.1% vs 26.7% 🔹ORR: 58.9% vs 31.1% 🔹mDOR 11.2 vs 7.1 mo ⬆️G3 or higher https://t.co/bPSBDsFeQ9
496 views 8 likes 2 RT 2026-05-29
Dr. Antonio Calles 🫁🚭
Dr. Antonio Calles 🫁🚭 @Tony_Calles
💊 Sunvozertinib is the first single oral agent to improve PFS over chemotherapy in 1L Exon 20 EGFRmut NSCLC although there were differences by subgroups that needs to be acknowledged. Simultaneous publication @NEJM Already approved by FDA for 2nd line. #ASCO26 #LCSM @Exon20Group https://t.co/HVOaI3wGAK
492 views 13 likes 6 RT 2026-05-29

WU-KONG28 Overview

WU-KONG28 (NCT05668988) is the first multinational, confirmatory Phase 3 randomized trial evaluating oral sunvozertinib monotherapy against platinum-pemetrexed chemotherapy as first-line treatment for advanced non-squamous NSCLC harboring EGFR exon 20 insertion mutations — a population historically underserved by classical EGFR TKIs. At ASCO 2026 (abstract LBA8500), the trial met its primary endpoint of blinded independent central review–assessed progression-free survival, with results published simultaneously in the New England Journal of Medicine. Sunvozertinib already holds FDA accelerated approval for previously treated EGFR exon20ins NSCLC and FDA Breakthrough Therapy Designation in the first-line setting; WU-KONG28 is the confirmatory study supporting potential first-line use.

Population

Treatment-naïve stage IIIB/IIIC/IV non-squamous NSCLC with confirmed EGFR exon 20 insertion mutations.

Intervention

Oral sunvozertinib 300 mg once daily vs carboplatin/pemetrexed with optional pemetrexed maintenance.

Primary Endpoint

Progression-free survival by blinded independent central review (RECIST 1.1).

Key Secondary

Overall survival, objective response rate (ORR), and duration of response (DOR).

Reported Results

Progression-Free Survival (Primary Endpoint)

Sunvozertinib significantly improved median PFS to 10.3 months vs 7.5 months for chemotherapy (HR 0.65; 95% CI, 0.50–0.85; p=0.0008). The 12-month PFS rate was 46.1% vs 26.7%.

Median PFS 10.3 vs 7.5 mo · HR 0.65Source: NEJM (LBA8500, ASCO 2026)

PFS2 (Exploratory Endpoint)

PFS2 — time from randomization to second progression or death — was a prespecified exploratory endpoint (not a secondary endpoint). In the ASCO oral presentation (LBA8500), median PFS2 was 21.7 months (95% CI, 16.1–24.3) with sunvozertinib vs 15.5 months (13.4–18.6) with chemotherapy (HR 0.70; 95% CI, 0.52–0.95; p=0.0111), suggesting the first-line benefit persists beyond initial progression — relevant context given that crossover to sunvozertinib was permitted, which dilutes the overall-survival comparison.

Exploratory · PFS2 21.7 vs 15.5 mo · HR 0.70Source: ASCO 2026 oral presentation (LBA8500), PFS2 slide

Objective Response Rate

Confirmed ORR was 58.9% with sunvozertinib vs 31.1% with chemotherapy, with responses observed across exon 20 insertion variant subtypes.

ORR 58.9% vs 31.1%Source: NEJM (LBA8500, ASCO 2026)

Overall Survival (Interim — Key Secondary)

At the interim analysis (38.9% maturity), median OS was 29.8 months (95% CI, 21.8–NE) with sunvozertinib vs 28.8 months (20.7–NE) with chemotherapy — HR 0.99 (95% CI, 0.70–1.40; p=0.48), i.e. no separation yet. This is expected: 90.2% of chemotherapy patients with confirmed progression crossed over to sunvozertinib, which heavily confounds the OS comparison. OS remains immature and follow-up is ongoing.

Interim OS HR 0.99 · 90.2% crossoverSource: ASCO 2026 presentation (LBA8500), interim OS slide

Safety & Tolerability

Sunvozertinib was administered as an all-oral, chemotherapy-free regimen. Full adverse-event profiles from the Phase 3 dataset are reported in the NEJM publication; diarrhea and skin-related events are the class-typical EGFR-TKI toxicities discussed by KOLs. CNS coverage in monotherapy was raised as an open question (@TejasPatilMD).

Source: NEJM (LBA8500, ASCO 2026)

FDA & Approval Status

STATUSSunvozertinib (Zegfrovy): approved in 2nd-line, investigational in 1st-line

Sunvozertinib holds FDA accelerated approval for adults with locally advanced or metastatic EGFR exon 20 insertion–positive NSCLC whose disease progressed on or after platinum-based chemotherapy (previously-treated setting). For the first-line setting evaluated in WU-KONG28, sunvozertinib has FDA Breakthrough Therapy Designation but is not yet approved — WU-KONG28 is the confirmatory Phase 3 trial supporting a potential first-line indication.

Source: FDA / Dizal (NDA 219839)

Media Coverage

What KOLs Are Saying

KOLCommentSentiment
Eric K. Singhi, MD
#ASCO26 · May 29, 2026
‼️ Phase 3 WU-KONG28: 1L Sunvozertinib v Chemotherapy in EGFR exon20 NSCLC ▫️mPFS 10.3 v 7.5 mos (HR 0.65) ▫️ORR ~60% v 30% Keep in mind, 1L PAPILLON (Amivantamab + chemo) is currently our SOC (mPFS 11.4 mos, ORR of 73%) #ASCO26 @ASCO ht Neutral
Hidehito HORINOUCHI
#ASCO26 · May 27, 2026
🆙 @OncoAlert #ASCO26 #LCSM 🔝🔟Abstracts Leads: @HHorinouchi @UOzkerim @WeOncologists 1 HARMONi-6 2 LIBRETTO-432 3 WU-KONG28 4 OptiTROP-Lung05 5 TRITON 6 CROWN 7yr 7 LORIN 8 AcceleRET-Lung 9 Silevertinib 10 Concurrent CRT + durvalumab in ES-S Neutral
Masahiro TORASAWA, MD. PhD.
#ASCO26 · May 28, 2026
🫁 #ASCO26 prep ❶ #️⃣LBA8500 | WU-KONG28 (Ph3, multinational) ✨ First multinational Ph3 RCT of sunvozertinib (oral EGFR exon20 ins–selective TKI) vs platinum-based chemotherapy as 1L in advanced NSCLC with EGFR exon 20 ins mutations 📊 Pri Neutral
Dr Amol Akhade
#ASCO26 · May 29, 2026
LBA8500: WU-KONG28 delivers a positive phase 3 result in EGFR exon20ins NSCLC. Sunvozertinib monotherapy improved PFS vs platinum/pemetrexed: • mPFS 10.3 vs 7.5 months • HR 0.65 (p=0.0008) • ORR 58.9% vs 31.1% • DoR 11.2 vs 7.1 months • 90 Neutral
Dr. Estela Rodriguez
#ASCO26 · May 29, 2026
And the concomitant #ASCO26 publications are out: #WU-KONG28 Ph3 trial of 1L #Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations ➡️ mPFS 10.3 vs 7.5 mos ⬆️ ORR 58.9% vs 31.1% ⚠️ AEs renal, GI, anemia 👎 FDA approved in July 2025 Neutral
Dr Amol Akhade
#ASCO26 · May 28, 2026
Three ASCO 2026 Day 1 LBAs to watch closely: ( only 3 of them in adult solid tumors -too low for Day 1 ? ) @dr_yakupergun 1 - WU-KONG28: Sunvozertinib vs platinum chemotherapy in frontline EGFR exon20ins NSCLC. Sunvozertinib is a next-gen Neutral
Yakup Ergün
#ASCO26 · May 29, 2026
WU-KONG28 was published in @NEJM simultaneously with #ASCO26 In 1L EGFR exon20ins NSCLC, oral sunvozertinib showed: PFS 10.3 vs 7.5 mos HR 0.65 12-month PFS: 46.1% vs 26.7% ORR 58.9% vs 31.1% In PAPILLON, 12-month PFS with ami-chemo was Neutral
Rami Manochakian MD, FASCO Cancer Education
#ASCO26 · May 29, 2026
🔥🚨@OncoAlert Hot off the press. Just published @NEJM in conjunction with presentation @ASCO #ASCO26 ⭐️Results of #WUKONG28 trial of: ✅#Sunvozertinib Vs #Chemotherapy For #1st line Tx of advanced #NSCLC with #EGFR #Exon20 insertion mutat Positive
Uğur Özkerim
#ASCO26 · May 28, 2026
🧬✨ASCO26 starts tomorrow and the lung cancer🫁 program really looks packed this year📢 From HARMONi-6 and LIBRETTO-432 to WU-KONG28, perioperative ALK strategies and KRAS/STK11-focused IO approaches, there’s a lot of potentially impactful t Neutral
Jordi Remon
#ASCO26 · May 29, 2026
WUKONG28: 1st line sunvozertinib (300 mg) improved PFS vs CT in mNSCLC & EGFRex20ins. First positive trial. Qx🧐 -dose:200 or 300? FDA approved 200 in 2L. Toxicity! -TKI alone or TKI+CT specially for EGFR20ins far-loop? -Other trials ongoing Neutral
Hidehito HORINOUCHI
#ASCO26 · May 29, 2026
🆙 #ASCO26 #LCSM Oral Abstract Session 🔥WU-KONG28: Sunvozertinib Monotherapy vs Platinum-Based Chemotherapy as First-Line Treatment for Advanced NSCLC with EGFR Exon20ins 🎙️Dr. John V. Heymach 🔢LBA8500 ☑️NCT05668988 🔗 https://t.co/xakJ6JI2Nk Positive
UT MD Anderson
#ASCO26 · May 29, 2026
Phase 3 data presented by Dr. John Heymach at #ASCO26 show sunvozertinib significantly improved progression-free survival and response rates compared with chemotherapy as a first-line treatment for advanced NSCLC with EGFR exon20ins mutatio Neutral
ilyas sahin, MD
#ASCO26 · May 29, 2026
WU-KONG28 in @NEJM and #ASCO26: First-line sunvozertinib beat chemo in advanced NSCLC with EGFR exon 20 insertions. PFS 10.3 vs 7.5 months (HR 0.65) Response rate 59% vs 31% (meaningful tumor shrinkage) Duration of response 11.2 vs 7.1 m Neutral
Ana I. Velázquez Mañana, MD, MSc, FASCO
#ASCO26 · May 29, 2026
🫁 #ASCO26 #LungCancer WU-KONG28: 1L Sunvozertinib in EGFR exon20ins NSCLC Compared to carbo/pemetrexed, sunvozertinib improved: 🔹mPFS 10.3 vs 7.5 mo (HR 0.65; 95% CI, 0.50 to 0.85) 🔹12mo PFS: 46.1% vs 26.7% 🔹ORR: 58.9% vs 31.1% 🔹mDOR Neutral
Dr. Antonio Calles 🫁🚭
#ASCO26 · May 29, 2026
💊 Sunvozertinib is the first single oral agent to improve PFS over chemotherapy in 1L Exon 20 EGFRmut NSCLC although there were differences by subgroups that needs to be acknowledged. Simultaneous publication @NEJM Already approved by FDA f Neutral
Chul Kim
#ASCO26 · May 29, 2026
Sunvozertinib improved PFS (10.3 vs 7.5 months; HR 0.65), ORR (58.9% vs 31.1%), and PFS2 (21.7 vs 15.5 months; HR 0.70) versus platinum doublet chemotherapy in EGFR exon20ins NSCLC. This will become an important treatment option in this spa Neutral
Dr Rishabh Jain
#ASCO26 · May 29, 2026
#ASCO26 EGFR exon 20 ins NSCLC has gone from “TKI-resistant niche mutation” to one of the fastest-moving spaces in thoracic oncology From limited activity with afatinib → high-dose osimertinib → dual-targeting with amivantamab → now next- Neutral
gilberto lopes
#ASCO26 · May 29, 2026
Block 1 - EGFR. •LBA8500 — Sunvozertinib monotherapy vs platinum chemo, first-line EGFR exon20ins NSCLC (WU-KONG28), multinational phase 3. Heymach, MD Anderson. The headline of the block: an oral exon20ins TKI challenging chemo in the fi Neutral
Tejas Patil
#ASCO26 · May 29, 2026
I think you will need chemotherapy, given FLAURA2 and PAPILLON. Same principles apply. I also worry about CNS coverage with sunvozertinib monotherapy. Neutral
Balazs Halmos
#ASCO26 · May 29, 2026
Sun-vozertinib rose over the frontline horizon today showing improved PFS over doublet chenotherapy for pts w advanced EGFR exon 20insertion mutation positive pts and w an oral option could be a fair 1st line option along w PAPILLON But no Neutral
Stephen V Liu, MD
#ASCO26 · May 29, 2026
Safety includes expected EGFR related toxicities such as diarrhea in 84% and rash in 52%, mostly low grade but some G3. CPK elevation with unclear significance clinically. Will sunvozertinib challenge PAPILLON? Awaiting clinical availabilit Neutral
Stephen V Liu, MD
#ASCO26 · May 29, 2026
#ASCO26 No survival difference noted in WU-KONG28 between sunvozertinib vs chemo: 29.8 vs 28.8 - immature and high crossover but no real signal in early part of the curve. https://t.co/Kc5jpC44sO Neutral
Manuel Dómine, MD, PhD
#ASCO26 · May 29, 2026
Sunvozertinib monotherapy versus platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR exon20ins: Primary analysis of a multinational phase 3 randomized study (WU-KONG28) oral session ASCO26# @Hospital_FJD @UAM_Ma Neutral
Jennifer A. Marks, MD
#ASCO26 · May 29, 2026
WU-KONG28 (1L sunvozertunib vs chemo) showed improved PFS2 of 21.7 vs 15m (OS immature) with prolonged DoR (11.2 v 7mo). CPK elevation seen in 20%. @ASCO #lcsm #lcsm #ASCO26 https://t.co/EKLoTPPntj Neutral
Yago Garitaonaindía
#ASCO26 · May 29, 2026
🔵 New in @NEJM & at #ASCO26: Sunvozertinib vs chemo, 1L EGFR exon 20 NSCLC (WU-KONG28) mPFS 10.3 vs 7.5 mo | HR 0.65 (0.50-0.85) ORR 58.9% vs 31.1% | mDOR 11.2 vs 7.1 mo First oral TKI to beat chemo 1L in exon 20. OS still immature. #L Neutral