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YL202 / BNT326 Trial

EGFR-mutant NSCLC (post-3rd gen TKI + platinum chemo) and HR+/HER2- breast cancer (post-CDK4/6i) — MediLink Therapeutics (Suzhou, China) + BioNTech (co-development license Oct 2023)

EGFR-mutant NSCLC (post-3rd gen TKI + platinum chemo) and HR+/HER2- breast cancer (post-CDK4/6i)ASCO 2024
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Top KOLs Discussing YL202 / BNT326

Hiroshi Horinouchi
Hiroshi Horinouchi
@HHorinouchi
2K impressions
d.planchard
d.planchard
@dplanchard
1.7K impressions
Mario Balsa
Mario Balsa
@MarioBalsaMD
1.5K impressions
Dr Rishabh Jain
Dr Rishabh Jain
@DrRishabhOnco
1.1K impressions

YL202 / BNT326 Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASCO 2024. Click any image to expand.

Hiroshi Horinouchi
Hiroshi Horinouchi @HHorinouchi
YL202 / BNT326 Data
2K impressions · 3 likes · Mar 21, 2026
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[Slide 1] Background YL202/BNT326 is an investigational HER3-targeting ADC conjugated to ~8 molecules (DAR 8) of a novel topoisomerase I inhibitor payload via a tripeptide linker. Targeting HER3 has shown promising clinical activity in NSCLC. We report the first clinical efficacy data of YL202/BNT326 monotherapy in pts with NSCLC (EGFRm, actionable genomic alterations [AGA]+/-) from an ongoing phase II trial. Methods Pts with NSCLC who progressed on standard of care received 2.0, 2.5, or 3.0 mg/kg YL202/BNT326 Q3W. Primary endpoints: investigator-assessed objective response rate (ORR) and recommended dose. Secondary endpoints include safety, and progression-free survival. Results As of October 27, 2025, 152 NSCLC pts had received ≥1 dose of YL202/BNT326. Median age: 59 years; all pts were Chinese, and 85.5% had ECOG 1. Efficacy was analyzed separately in patients with EGFRm NSCLC (n=96), AGA-negative non-squamous NSCLC (n=27), squamous NSCLC (n=22). With a median follow-up of 7.8 m, ORR was 41.7% in EGFRm, 48.1% in AGA- non-squamous, and 22.7% in squamous NSCLC (Table). Treatment-related adverse events (TRAEs) occurred in 148 pts (97.4%), 61 (total: 40.1%, 2 mg/kg: 26.4%, 3 mg/kg: 55.8%) had Grade >3, 8 pts (5.3%) discontinued treatment due to TRAEs, and one 1 pt died from pneumonia (2.0 mg/kg). Common TRAEs: anemia (67.8%), nausea (44.7%), and decreased appetite (43.4%). Grade ≥3 TRAEs: decreased lymphocyte count (13.2%), anemia (10.5%), decreased neutrophil count (8.6%) and white blood cell count (7.9%). 1 pt had interstitial lung disease (ILD). Table: 11MO 3L+ EGFRm NSCLC (prior TKI & non-squamous NSCLC AGA squamous platinum-based chemotherapy) negative NSCLC 2.0 2.5 3.0 2.0 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg Total Total Total mg/kg mg/kg mg/kg mg/kg N=33 N=30 N=33 N=96 N=27 N=22 N=15 N=3 N=9 N=22 Unconfirmed ORR by investigator 40 13 5 n (%) 11 (33.3) 12 (40.0) 17 (51.5) 7 (46.7) 1 (33.3) 5 (55.6) 5 (22.7) (41.7) (48.1) (22.7) 31.7, 21.3, 21.2, 28.7, 7.8, 95% CI 18.0, 51.822.7, 59.433.5, 69.2 0.8, 90.6 7.8, 45.4 52.2 73.4 86.3 68.1 45.4 PFS by investigator, months Median 6.9 6.0 8.2 7.2 5.6 2.8 10.0 5.6 4.4 4.4 95% CI 4.8, 8.2 4.2, NC 6.7, 9.9 5.8, 8.2 5.4, NC 1.8, NC 1.2, NC 5.4, 8.34.2, NC 4.2, NC Conclusions The HER3 ADC YL202/BNT326 shows encouraging efficacy with a manageable safety profile (low neutropenia and ILD rates) in 2L+ non-sq/squamous NSCLC pts without AGA and confirms activity in EGFR-mutated pts. Based on these results, YL202/BNT326 is being evaluated in combination with pumitamig (BNT327), an investigational anti-PD-L1xVEGF-A bispecific antibody, in NSCLC (NCT07111520).
d.planchard
d.planchard @dplanchard
YL202 / BNT326 Data
1.7K impressions · 33 likes · Mar 27, 2026
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[Slide 1] Summary of studies in 2L and beyond EGFR-mutant mNSCLC with sensitizing mutations MARIPOSA-2 OptiTROP- LBA4 MO9 MO10 MO11 Ami+chemo Lung04 Sac-TMT TQB2922 SHRA2009 YL202/BNT326 2L 2L 3L 2L ≥2L 3L ORR % 64% 61% 45% 24%/65% 43% 34% DOR, months 6.9 8.3 7.0 5.6/6.9 9.7 7.0 PFS, months 6.3 8.3 7.9 /8.1 8.1/14.4 7.5 OS, months or 17.7 20.0 rate,% 18-mo 50% 18-mo 66% 18-mo 55% 12-mo 80% Comparison or vs P-chemo vs P-chemo VS docet mono or combo with mono arm HR=0.73 HR=0.6 HR=0.45 combo with 3rd TKI Aumol P-chemo 21 sur 23 Invited discutant K.Oselin --- [Slide 2] LBA4 elcc European Lung Cancer Congress 2026 Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC): final overall survival (OS) analysis from the randomized OptiTROP-Lung03 study Wenfeng Fang¹, Xingya Li², Qiming Wang3.4 Xiangjiao Meng⁵, Wei Zheng⁶, Longhua Sun', Wenxiu Yao8, Wu Zhuang9, Yun Fan¹⁰, Minglei Zhuo¹¹, Yongzhong Luo¹², Zhiye Zhang¹³, Xia Song¹⁴, Runxiang Yang¹⁵, Jiacheng Yang¹⁶, Yina Diao¹⁶, Junyou Ge¹⁶, 17 Li Zhang¹, Yunpeng Yang¹ 'Sun Yat sen University Cancer Center, Guangzhou China, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China Institute of Cancer Research Henan Academy of Innovations in Medical Science, Zhengzhou, China; Shandong Cancer Hospital and Institute, Shandong First Medical University Jinan, China, Shenging Hospital of China Medical University, Shenyang. China The First Affiliated Hospital of Nanchang University, Nanchang, China, Sichuan Cancer Hospital, Chengdu, China, Fujian Cancer Hospital, Fuzhou, China "Zhejiang Cancer Hospital, Hangzhou, China, "Beijing Cancer Hospital, Beijing, China, Hunan Cancer Hospital, Changsha, China The First Affiliated Hospital of Henan University of Science and Technology, Luoyang China, "Shanxi Cancer Hospital, Tayuan, China 15Yunnan Cancer Hospital, Kunming, China; "Sichuan Kelun Biotech Biopharmaceutical Co., Ltd., Chengdu, China: "National Engineering Research Center of Targeted Biologics, Chengdu China Presenter: Yunpeng Yang Sun Yat-sen University Cancer Center, Guangzhou, China 25-28 March 2026 --- [Slide 3] LBA4 Overall Survival Adjusted for Crossover In the docetaxel group, 41.3% (19/46) of pts received sac-TMT as subsequent anti-cancer therapy. After using RPSFT model adjusted for crossover, sac-TMT significantly improved OS over docetaxel with 55% lower risk of death. Sac-TMT Docetaxel 100 (n=91) (n = 46) OS events, n (%) 51 (56.0) 30 (65.2) 80 Median OS, months (95% CI) 20.0 (14.8, NE) 11.2 (8.0, 16.1) 18-month OS rate, % (95% CI) 54.7 (43.9, 64.3) 9.1 (0.7, 31.7) Derail 2 60 54.7% HR: 0.45 (95% Cl: 0.28, 0.73) Progression-Free Survival by Investigator 40 20 Sac-TMT 9.1% Docetased 100 Consomed 0 0 3 6 9 12 15 18 21 24 27 so Time (Months) No Risk Sac-TMT 91 ISS 83 73 63 54 49 41 16 0 Progresion Survival 60 Docetaxel 46 41 35 28 21 9 I I 0 40 30.2% 20 Sac-TMT Docutaxel 2.2% Careoned 0 0 3 6 9 12 15 is 21 24 Sac-TMT Docetaxel Time (Months) No. at Risk (n 91) (n 46) Sac-TMT 91 68 50 12 24 14 11 9 0 PFS events, n (%) 72 (79.1) 46 (100) Docetased 46 20 5 2 I 0 Median PFS, months (95% CI) 7.9 (6.2,9.5) 2.8 (1.5, 3.8) 12-month PFS rate, % (95% CI) 30.2 (20.6, 40.4) 2.2 (0.2, 10.0) HR: 0.23 (95% Cl: 0.15, 0.35) Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. --- [Slide 4] Summary of studies in 2L and beyond EGFR-mutant mNSCLC with sensitizing mutations MARIPOSA-2 OptiTROP- LBA4 MO9 MO10 MO11 Ami+chemo Lung04 Sac-TMT TQB2922 SHRA2009 YL202/BNT326 2L 2L 3L 2L ≥2L 3L ORR % 64% 61% 45% 24%/65% 43% 34% DOR, months 6.9 8.3 7.0 5.6/6.9 9.7 7.0 PFS, months 6.3 8.3 7.9 /8.1 8.1/14.4 7.5 OS, months or 17.7 20.0 rate,% 18-mo 50% 18-mo 66% 18-mo 55% 12-mo 80% Comparison or vs P-chemo vs P-chemo VS docet mono or combo with mono arm HR=0.73 HR=0.6 HR=0.45 combo with 3rd TKI Aumol P-chemo 21 sur 23 Invited discutant K.Oselin
Dr Rishabh Jain
Dr Rishabh Jain @DrRishabhOnco
YL202 / BNT326 Data
1.1K impressions · 9 likes · Mar 27, 2026
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[Slide 1] HER3 ADC enters the NSCLC space @DrRishabhOnco # ELCC26 First efficacy data of YL202/BNT326 in heavily pretreated NSCLC Study Population Drug 3L NSCLC post TKI + HER3 ADC with topo-1 platinum payload (DAR 8) EGFRm (n=96) 2.0-3.0mg/kg Q3W AGA-non-sq (n=27) Squamous (n=22) Efficacy Objective Response Rate (ORR) EGFRm: 41.7% AGA- non-sq: 48.1% Squamous: 22.7% Squamous: 22.7% ! Safety Grade ≥3 TRAEs in 40% Low ILD risk (1 pt) 5.3% discontinued due to TRAEs
Mario Balsa
Mario Balsa @MarioBalsaMD
YL202 / BNT326 Data
813 impressions · 10 likes · Mar 27, 2026
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[Slide 1] Study Design (NCT06092268) Part A1 (≥2L setting) Part A2 (1L setting) Dose exploration Efficacy expansion RP2D phase 1b phase 1b (phase 1b) (phase 2) SHR-A2009 (8 mg/kg) + A (110 mg)1 Part A1: SHR-A2009+A in >2L EGFRm NSCLC post EGFR-TKI* R1: SHR-A2009 (6 mg/kg) + A (110 mg) SMC continuously Part A2: SHR-A2009+A in 1L EGFRm NSCLC* SHR-A2009 (6 mg/kg) + A (110 mg) R Part A3: SHR-A2009+3 G EGFR-TKI (INV's choice) in 1L EGFRm NSCLC* 1:1 SHR-A2009 (8 mg/kg) + A (55 mg) R2: SHR-A2009 (6 mg/kg) + A (110 mg) Part B: SHR-A2009+Ade in AGA- NSCLC 4-8 cycles + A (110 mg) maintenance SHR-A2009 (6 mg/kg) + A (55 mg) Part C1: SHR-A2009+Bev in >2L EGFRm NSCLC* All regimens SHR-A2009 (IV, Q3W) A(PO, QD) n 3-wk cycles, N up to -30 patients per regimen Part C2: SHR-A2009+Ade+Bev in >2L EGFRm NSCLC* Primary objectives: safety, tolerability, RP2D Part C3: SHR-A2009+Bev in other advanced solid tumors Secondary objectives: PK profile, immunogenicity, preliminary efficacy As of datacutoff (Nov. 20, 2025) Patients enrolled and received assigned treatment: n=79 in Part A1; n=61 in Part A2 Median follow-up: 11.3 mo in Part A1; 16.7 mo in Part A2 "Mutation status was determined by tumor tissue or blood based testing Initial starting dose was SHR-A2009 9 mg/kg A 110 mg, which was subsequently revised via a protocol amendment G, generation, Ade, adebrelimab; AGA actionable genomic alteration, Bev. bevacizumab; INV, investigator, R1/2 regimen 1/2 RP20, recommended phase 2 dose, SMC safety monitoring committee Yi-Long Wu, Guangdong Lung Cancer Institute, China Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use INTERNATIONAL ESMO IASLC ESTRO h ETOP-IBCSG LINE CANCER --- [Slide 2] Safety Profile Summary Common TRAEs⁺ 2L setting 1L setting >2L setting 1L setting All patients (n=79) All patients (n=61) Any AE 79 (100.0) 61 (100.0) Anaemia 16.5 82.3 Anaemia 3.3 67.2 Grade >3 55 (69.6) 26 (42.6) Neutrophil count decreased 29.1 74.7 Nausea 4.9 63.9 Any TRAE 79 (100.0) 61 (100.0) WBC count decreased 12.7 62.1 Decreased appetite 3.3 55.8 Grade >3 47 (59.5) 19 (31.1) Nausea 5.1 62.1 Decreased appetite 5.1 55.7 Neutrophil count decreased 1.6 54.1 TRAE leading to dose reduction AST increased 1.3 41.8 Vomiting 1.6 54.1 SHR-A2009 18 (22.8) 7 (11.5) Vomiting 2.5 39.2 Blood CPK increased 6.6 45.9 A 2 (2.5) 1 (1.6) ALT increased 0.0 36.7 WBC count decreased 0.0 44.3 Platelet count decreased 10.1 29.1 TRAE leading to dose Blood CPK increased 5.1 27.9 ALT increased 3.3 41.0 discontinuation GGT increased 5.1 26.6 Any agent 6 (7.6)* 9 (14.8) Stomatitis 1.6 37.7 SHR-A2009 Asthenia 2.5 25.3 6 (7.6)* 8 (13.1) Blood creatinine increased 0.0 32.8 Alopecia 0.0 22.8 A 6 (7.6)* 3 (4.9) Weight decreased 1.6 22.9 Proteinuria 0.0 20.3 Serious TRAE 26 (32.9) 12 (19.7) Lymphocyte count 7.6 17.7 Platelet count decreased 0.0 21.3 TRAE leading to death 0 1 (1.6) decreased ILD 6 (7.6) 3 (4.9) 0 20 40 60 80 100 0 20 40 60 80 100 Grade >3 3 (3.8) 1 (1.6) Incidence (%) Incidence (%) Grade 1-2 Grade 23 Grade 1-2 Grade >3 Data are n (%). '4 8% (3/62) at SHR-A2009 6 mg/kg A 110 mg/SHR-A2009 8 mg/kg A55 mg All TRAEs of any grade reported in >20% of patients and of grade >3 in >5% are listed AE. adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; GGT, garma-glutamy/transferase ILD, interstitial lung disease; TRAE. treatment-related adverse event; WBC. white blood cell Yi-Long Wu., Guangdong Lung Cancer Institute, China Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASLC INTERNATIONAL ENDY ESTRO CANCER h ETOP-IBCSG --- [Slide 3] Tumor Response (≥2L Setting) SHR-A2009 9 mg/kg + A 110 mg SHR-A2009 8 mg/kg + A 110 mg SHR-A2009 6 mg/kg + A 110 mg SHR-A2009 8 mg/kg + A 55 mg SHR-A2009 6 mg/kg + A 55 mg PRt SD . PD NE Treatment ongoing 40 20 Best percentage change from baseline 0 in target lesion (%) -20 -40 -60 -80 -100 0 2 4 6 8 10 12 14 16 18 20 Duration on SHR-A2009 (mo) SHR-A2009 6 mg/kg + A 110 mg (n=32) SHR-A2009 8 mg/kg + A 55 mg (n=30) All patients (n=79) Confirmed ORR* (n/N; 95% CI), % 43.8 (14/32; 26.4-62.3) 51.7 (15/29; 32.5-70.6) 42.9 (33/77; 31.6-54.6) DCR* (n/N; 95% CI), % 90.6 (29/32; 75.0-98.0) 96.6 (28/29; 82.2-99.9) 93.5 (72/77; 85.5-97.9) Median DoR (95% CI), mo 13.5 (4.3-NR) 9.7 (5.9-NR) 9.7 (5.7-NR) Ongoing response, % (n/N) 57.1 (8/14) 60.0 (9/15) 51.5 (17/33) . Based on efficacy evaluable set; other outcomes based on full analysis set Tinclude unconfirmed responses (n=2) DCR, disease control rate; DoR, duration of response; NE, not evaluable; NR, not reached; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease Yi-Long Wu, Guangdong Lung Cancer Institute, China Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use a ESMO IASLC ESTRO L ETOP-IBCSG D4 CANCER PARTNERS FOUNDATION --- [Slide 4] Tumor Response (1L Setting) SHR-A2009 6 mg/kg + A 110 mg R1 SHR-A2009 6 mg/kg + A 110 mg R2 PR* SD PD Treatment ongoing 20 R1: SHR-A2009 0 continous dosing Best percentage change from baseline -20 in target lesion (%) -40 -60 R2: SHR-A2009 for the first 4-8 cycles -80 -100 0 2 4 6 8 10 12 14 16 18 20 22 Duration on SHR-A2009 (mo) SHR-A2009 6 mg/kg SHR-A2009 6 mg/kg All patients + A 110 mg R1 (n=31) + A 110 mg R2 (n=30) (n=61) Confirmed ORR (n/N; 95% CI), % 77.4 (24/31; 58.9-90.4) 66.7 (20/30; 47.2-82.7) 72.1 (44/61; 59.2-82.9) DCR (n/N; 95% CI), % 96.8 (30/31; 83.3-99.9) 90.0 (27/30; 73.5-97.9) 93.4 (57/61; 84.1-98.2) Median DoR (95% CI), mo NR (NR-NR) 15.7 (NR-NR) 15.7 (NR-NR) Ongoing response, % (n/N) 79.2 (19/24) 75.0 (15/20) 77.3 (34/44) 1 All confirmed. DCR, disease control rate, DoR, duration of response, NE, not evaluable NR, not reached ORR, objective response rate, PD. progressive disease PR partial response, SD, stable disease Yi-Long Wu., Guangdong Lung Cancer Institute, China Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASLC ESTRO CANCER L ETOP-IBCSG
Mario Balsa
Mario Balsa @MarioBalsaMD
YL202 / BNT326 Data
706 impressions · 10 likes · Mar 27, 2026
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[Slide 1] YL202-CN-201-01 trial design (NCT06107686) A multicenter, open-label, Phase 2 study to evaluate the efficacy, safety, and pharmacokinetics of YL202/BNT326 (investigational HER3 ADC) in patients with advanced solid tumors: We report efficacy and safety from 152 patients with NSCLC Number of Select cohorts Doses patients* Treatment N=102 2.0 mg/kg, 2.5 mg/kg, 3.0 mg/kg until PD, Cohort A2: NSCLC with EGFRm with prior TKI and PBC IV Q3W intolerable toxicity, or Cohort E1: Squamous NSCLC with 1-2 prior lines withdrawal N=23 2.0 mg/kg IV Q3W (must include PD-(L)1 + chemotherapy) of informed Cohort E2: Non-squamous, AGA-negative NSCLC with 1-2 prior N=27 2.0 mg/kg, 2.5 mg/kg, 3.0 mg/kg consent lines (must include PD-(L)1 + chemotherapy) IV Q3W "All cohorts completed enrollment Enrollment for this cohort began later, therefore, only the 20 mg/kg dose level was evaluated Primary endpoints: Secondary endpoints include: Investigator-assessed ORR (per RECIST v1.1) and recommended dose of YL202/BNT326 for the pivotal study PFS, DCR, DoR, safety Data cutoff January 27, 2026 AGA, actionable genomic alteration; DCR, disease control rate; DoR, duration of response; EGFR, epidermal growth factor receptor-EGFRm activating EGFR mutation; IV, intravenous; NSCLC. non small cell lung cancer; ORR, objective response rate; PBC, platinum based chemotherapy; PD, progressive disease, PD-(L)1, programmed death-(ligand) 1: PFS, progression-free survival; Q3W, every 3 weeks; RECIST v1.1, Response Evaluation Critena in Solid Tumors version 1.1; TKI, fyrosine kinase inhibitor Organisers Partners Presented by Haifeng Liu Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASLC ESTRO h ETOP-IBCSG CANCER --- [Slide 2] Clinical activity in 3L+ treatment of NSCLC with EGFRm Clinical activity was observed across dose levels 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg Total (n=33) (n=30) (n=33) (N=96) 100 Median follow-up 10.7 9.1 16.3 10.1 80 duration, months Confirmed ORR, n (%) 9 (27.3) 8 (26.7) 16 (48.5) 33 (34.4) 60 95% CI (13.3,45.5) (12.3,45.9) (30.8,66.5) (25.0, 44.8) 40 Unconfirmed ORR, n (%) 11 (33.3) 12 (40.0) 17 (51.5) 40 (41.7) 95% CI (18.0,51.8) (22.7,59.4) (33.5,69.2) (31.7, 52.2) Confirmed DCR, n (%) 30 (90.9) 25 (83.3) 31 (93.9) 86 (89.6) 95% CI (75.7,98.1) (65.3,94.4) (79.8,99.3) (81.7,94.9) 6.9 6.8 Best percentage change from baseline in target lesion sum of longest diameters 20 0 -20 Median DoR, months 8.4 7.0 95% CI (4.40, NC) (7.49, NC) (3.91,7.62) (6.74,8.84) -40 Median PFS, months 8.1 7.1 8.2 7.5 -60 95% CI (4.83,8.94) (4.21,9.86) (5.75, 9.69) (5.91, 8.84) -80 80.9 76.7 90.2 82.7 3 months -100 PFS, % (62.3,90.9) (57.2,88.1) (72.4,96.8) (73.3, 89.0) 95% CI 54.3 58.9 65.9 59.6 6 months 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg (35.2, 69.9) (39.0,74.3) (44.3,80.7) (48.4,69.2) Efficacy data are available for 96/102 patients with EGFRm NSCLC Data cutoff January 27, 2026. Organisers Partners 3L+, third or later line; CI, confidence interval, NC, not calculable ESMO IASLC INTERNATIONAL Presented by Haifeng Liu Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESTRO L ETOP-IBCSG LUNG CANCER PARTNERS FOUNDATION --- [Slide 3] Clinical activity in 2L+ treatment of squamous NSCLC Encouraging preliminary antitumor activity in patients with squamous NSCLC who received 2.0 mg/kg YL202/BNT326* 2.0 mg/kg (N=22) 100 Median follow-up 10.6 80 duration, months Confirmed ORR, n (%) 2 (9.1) 60 95% CI (1.1, 29.2) 40 Unconfirmed ORR, n (%) 5 (22.7) 95% CI (7.8, 45.4) Confirmed DCR, n (%) 18 (81.8) 95% CI (59.7, 94.8) Best percentage change from baseline in target lesion sum of longest diameters 20 0 -20 Median DoR, months 4.8 95% CI (4.11, NC) -40 Median PFS, months 5.5 -60 95% CI (4.21, 9.69) -80 80.0 3 months PFS, % (54.9, 92.0) -100 95% CI 43.3 6 months 2.0 mg/kg (20.0, 64.7) Efficacy data are available for 22/23 patients with squamous NSCLC Data cutoff January 27, 2026 "Enrollment for this cohort began later, therefore, only the 2 0-mg/kg dose level was evaluated Organisers Partners 2L+, second or later Ine. Presented by Haifeng Liu Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASLC ESTRO L ETOP-IBCSG CARCER --- [Slide 4] Clinical activity in 2L+ treatment of non-squamous, AGA-neg NSCLC Encouraging preliminary antitumor activity in patients with non-squamous, AGA-neg NSCLC 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg Total (n=15) (n=3) (n=9) (N=27) 100 Median follow-up 10.74 3.71 19.78 11.47 80 duration, months Confirmed ORR, n (%) 7 (46.7) 0 3 (33.3) 10 (37.0) 60 95% CI (21.3,73.4) (0.0, 70.8) (7.5,70.1) (19.4, 57.6) 40 Unconfirmed ORR, n (%) 7 (46.7) 1 (33.3) 5 (55.6) 13 (48.1) 95% CI (21.3,73.4) (0.8,90.6) (21.2,86.3) (28.7, 68.1) Confirmed DCR, n (%) 15 (100) 3 (100) 6 (66.7) 24 (88.9) 95% CI (78.2, 100) (29.2, 100) (29.9,92.5) (70.8, 97.6) Best percentage change from baseline in target lesion sum of longest diameters 20 0 -20 Median DoR, months 7.0 NA 9.4 7.0 95% CI (4.17, NC) (5.36, NC) (4.40, NC) -40 Median PFS, months 5.6 2.8 8.2 5.6 -60 95% CI (5.49, NC) (1.81, NC) (1.22, NC) (5.39, 8.34) -80 93.3 50.0 76.2 83.6 3 months PFS, % (61.3,99.0) (0.6,91.0) (33.2,93.5) (61.9, 93.6) -100 95% CI 46.7 0.0 76.2 48.4 6 months 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg (21.2, 68.7) (NC, NC) (33.2, 93.5) (27.3, 66.7) Efficacy data are available for all 27 patients with non-squamous NSCLC without AGA Organisers Partners Data cutoff: January 27, 2026. ESMO IASLC Presented by Haifeng Liu Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESTRO L ETOP-IBCSG CANCER PARTNERS FOUNDATION

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About the YL202 / BNT326 Trial

YL202/BNT326 is MediLink Therapeutics' (China) + BioNTech's HER3-directed ADC, structurally analogous to Daiichi Sankyo's patritumab deruxtecan (HER3-DXd). Phase 1 first-in-human (N=52): encouraging ORR 41% in DL3-5 (54.5% in heavily pretreated HR+/HER2- BC), DCR 93.5% across all, low ILD rate (1 case after COVID). Directly competes with HER3-DXd which HERTHENA-Lung01 failed to achieve FDA approval in EGFR NSCLC (Daiichi withdrew application 2024) — YL202/BNT326 may face similar regulatory headwinds in this line/biomarker context. Clinical value depends on Phase 2/3 confirmation.

Trial Methodology & Results

Safety, Tolerability, DLTs, AEs (Phase 1 FIH) — Primary Endpoints

All evaluable (N=46) rate: 37.0% (ORR %) vs. 93.5% (DCR %) vs. 8.4% (mDOR months) vs. 61.6% (6-mo PFS %). DL3-DL5 dose range (N=39) rate: 41.0% (ORR %) vs. 25.6-57.9% (95% CI) vs. 94.9% (DCR %) vs. 82.7-99.4% (95% CI DCR). Breast cancer subset (n=13) rate: 54.5% (ORR %) vs. 23.4-83.3% (95% CI) vs. 100% (DCR %) vs. 71.5-100% (95% CI DCR). Phase 1 first-in-human, open-label, multinational trial. HER3-targeted ADC: anti-HER3 IgG1 mAb + 8 molecules YL0010014 (novel topo-I inhibitor) via tripeptide linker. N=52 enrolled (39 NSCLC, 13 BC). Dose escalation: 6 dose levels Q3W with BOIN design + cohort backfill. Population: EGFR-mutant NSCLC post-3rd gen TKI + platinum chemo; HR+/HER2- mBC post-CDK4/6i + ≥1 chemo (median 4 prior lines, range 2-8). Primary endpoints: safety/tolerability (DLTs, AEs). DLT: 1 Grade 3 febrile neutropenia at highest dose (DL6). ORR all evaluable (N=46) 37.0% (95% CI 23.2-52.5); DCR 93.5% (95% CI 82.1-98.6); mDOR 8.4 months. DL3-DL5 dose range: ORR 41.0% across all tumor types; BC subset ORR 54.5%, DCR 100%. 6-month PFS 61.6%. Zhang et al., JCO 2024;42(16)_suppl:3034.

✓ DL3-5 ORR 41.0%; BC ORR 54.5%; DCR 100% (BC)

📄 Source: KOL commentary on X →

Overall Survival (OS)

Phase 1 — mature PFS/OS not reported. Strong signal in BC (54.5% ORR heavily pretreated) supports further Phase 2/3 development. Safety generally manageable.


📄 Source →

Safety & Tolerability

Key AEs: anemia (71% all-grade, 20% G≥3), WBC decreased (67% all-grade, 31% G≥3), neutrophil decreased (63% all-grade, 29% G≥3), nausea (52%), decreased appetite (42%), lymphocyte decreased (37% all-grade, 23% G≥3), thrombocytopenia (37% all-grade, 10% G≥3), vomiting, dry mouth, fatigue, stomatitis, alopecia. Interstitial pneumonia in 1 patient (2%, after COVID-19 infection) — notable given class risk of topoisomerase-I ADCs. PK exposure increased with dose escalation; low systemic payload exposure; no accumulation upon repeated administration. Hematologic toxicity predominant; non-heme TRAEs largely low-grade.

⚠ Hematologic tox dominant; 1 ILD case (post-COVID)

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Clinical Implications

🔬 Phase 1 signal: MediLink/BioNTech HER3 ADC active in post-TKI EGFR NSCLC + HR+/HER2- BC. YL202/BNT326 is MediLink Therapeutics' (China) + BioNTech's HER3-directed ADC, structurally analogous to Daiichi Sankyo's patritumab deruxtecan (HER3-DXd). Phase 1 first-in-human (N=52): encouraging ORR 41% in DL3-5 (54.5% in heavily pretreated HR+/HER2- BC), DCR 93.5% across all, low ILD rate (1 case after COVID). Directly competes with HER3-DXd which HERTHENA-Lung01 failed to achieve FDA approval in EGFR NSCLC (Daiichi withdrew application 2024) — YL202/BNT326 may face similar regulatory headwinds in this line/biomarker context. Clinical value depends on Phase 2/3 confirmation.

YL202 / BNT326 in the News

Key KOL Sentiments — YL202 / BNT326

DoctorSentimentComment
Hiroshi Horinouchi ● NEUTRAL 🆙 #ELCC26 @myESMO 🇩🇰 🔥Mini Oral session 2 ☑️YL202/BNT326: HER3 ADC 🎯ORR across doses: 22.7-55.6% 🎯mPFS across doses: 2.8-10.0m 🎙️Dr. Haifeng Liu 🎙️Chair: Dr. Kersti Oselin @MARIANOPROVENCI 📍NCT06107686 @OncoAlert @Larvol #LCSM https://t.co/q4Td3ABd8v https://t.co/VTQuHubACN
d.planchard ● NEUTRAL Great EGFR-mutant NSCLC session. Impressed by the Sac-TMT results (anti-TROP2 ADC), which show the most positive outcomes across two Chinese studies. Other ADCs are also in the pipeline, things are really moving for the post-Osimertinib +/- chemo setting. #ELCC2026 #EGFR https://t.co/eeBYVTRTx6
Dr Rishabh Jain ● NEUTRAL 🔥 HER3 ADC enters the NSCLC space #ELCC26 First efficacy data of YL202/BNT326 in heavily pretreated NSCLC 👇 🧬 Study population • ≥3L NSCLC post TKI + platinum • EGFRm (n=96) | AGA– non-sq (n=27) | Squamous (n=22) 💊 Drug • HER3 ADC with topo-I payload (DAR 8) • 2.0–3.0 https://t.co/P740VpaeYj https://t.co/cBzyGyDzDq
Mario Balsa ● NEUTRAL ✨ Mini oral session 2 at #ELCC26: SHR-A2009 (HER3 ADC) + aumolertinib in EGFRm NSCLC (Ph1b/2) 🎯 ORR: 72.1% (1L) | 42.9% (≥2L) 📈 Durable responses (DoR up to 15.7 mo) ⚠️ TRAE G≥3: 31.1% (1L) | 59.5% (≥2L) Strong signal for HER3 + EGFR combo🚀 @OncoAlert @myESMO https://t.co/ljdmm9yDwv
Mario Balsa ● NEUTRAL ✨ Mini oral session 2 at #ELCC26: YL202/BNT326 (HER3 ADC) in NSCLC with EGFRm (cohort A2) and squamous NSCLC (cohort E1) (Ph2) 🎯 ORR 34.4%/mPFS 7.5-8.1 mo (EGFRm ≥3L) 👍 Manageable safety, low discontinuation 🚀 Activity across multiple NSCLC subgroups HER3 ADCs spreading https://t.co/Z8Q5MC8LBr