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TAISHAN-302 Trial

TAISHAN-302 (NCT06612151) is the phase III trial of tambotatug pelitecan (Tam-Peli, an investigational B7-H3-directed ADC; MediLink Therapeutics, licensed to Roche outside greater China) versus topotecan in relapsed small-cell lung cancer. Presented at WCLC 2026 (LBA 1840, Presidential Symposium) and published in NEJM: overall survival 13.3 vs 9.4 months (HR 0.46), with fewer severe adverse events than topotecan.

Phase III · NCT06612151 Sponsor: MediLink Therapeutics · Roche (ex-China license) ⚠️ Tam-Peli — investigational, not FDA approved WCLC 2026 Presidential Symposium · NEJM N=451 · Relapsed SCLC (2L)

TAISHAN-302 at a Glance

Design

Phase III, randomized 1:1, tambotatug pelitecan (B7-H3-directed ADC with topoisomerase-1 payload; MediLink Therapeutics, Roche license ex-China) versus topotecan in 451 patients with relapsed SCLC after platinum-based therapy. Presented by Prof. Li Zhang at the WCLC 2026 Presidential Symposium; simultaneously published in NEJM. (WCLC26 LBA 1840; NEJM)

Efficacy

Median OS 13.3 vs 9.4 months, HR 0.46 — a 54% reduction in the risk of death — with PFS HR 0.29 (95% CI 0.23–0.37) and significantly improved ORR, consistent regardless of baseline metastasis status or chemotherapy-free interval. (NEJM; WCLC26 presentation slides via KOL capture)

Safety

Grade ≥3 adverse events 55% vs 78% (treatment-related Gr≥3: 46.4% vs 74.7% per the presented slides) — fewer severe events with the ADC than with topotecan. The class toxicity to watch: ILD/pneumonitis in 4.9% vs 1.4%. (WCLC 2026 presented slides via verbatim physician captures on this page)

Regulatory status

⚠️ Tambotatug pelitecan is investigational — not approved anywhere. It holds U.S. FDA and China CDE Breakthrough Therapy Designations for relapsed SCLC. The investigators' presented conclusion: these results support Tam-Peli as a potential new standard-of-care option for second-line SCLC. (Roche media release Sept 13, 2026; IASLC press release)

KOL pulse

Ilyas Sahin (verbatim, on this page): “Longer survival, much higher response, and less severe toxicity ; a striking result in relapsed SCLC.” The sequencing question — where a B7-H3 ADC sits against DLL3-directed therapy in second line — ran through the physician threads.

KOLs Discussing TAISHAN-302

Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
3,950 impressions
Stephen V Liu, MD
Stephen V Liu, MD
@StephenVLiu
3,556 impressions
ilyas sahin, MD
ilyas sahin, MD
@ilyassahinMD
3,094 impressions
Noemi Reguart
Noemi Reguart
@NReguart
2,973 impressions
Masahiro TORASAWA, MD. PhD.
Masahiro TORASAWA, MD. PhD.
@M_Torasawa
2,547 impressions
Dr Rishabh Jain
Dr Rishabh Jain
@DrRishabhOnco
2,392 impressions

Key Slides & Data

Slides shared by global KOLs, mirrored to our CDN; slide text panels are verbatim Textract OCR.

Hidehito HORINOUCHI
TAISHAN-302 — shared slides
WCLC 2026 · 2026-09-13
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[Slide 1] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -02 min 18s on Lung Cancer SEOUL, REPUBLIC OF KOREA TAISHAN-302 Study Design A multicenter, randomized, open-label, phase 3 study (NCT06612151) Treatment until disease progression per RECIST v1.1 or intolerable toxicity. Crossover between arms is not permitted. Primary endpoint: Key eligibility criteria: OS Tam-Peli Histologically or cytologically 2.0 mg/kg, D1 Q3W, Key secondary endpoints: confirmed SCLC maximum dose of 200 mg PFS by investigators R ORR by investigators Progressed after 1 prior line of platinum-based therapy 1:1 Other secondary endpoints: Topotecan DCR, DoR, TTR by investigators At least one measurable lesion per RECIST v1.1 N=451 Safety, PK, and immunogenicity 1.2 mg/m², D1-5 Q3W* ECOG PS 0-1 Exploratory endpoints: Intracranial efficacy Stratification factors Disease status (local** or systemic disease) Brain metastasis (yes or no) Chemotherapy-free interval (<90 or ≥90 days) * Per the prescribing information approved in China ** Patients with local disease defined as those initially diagnosed with limited-stage disease who developed local recurrence within 6 months after platinum-based chemotherapy plus definitive radiotherapy D, day: DCR, disease control rate; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ORR, objective response rate; OS, overall survival: PFS, progression-free survival; PK, pharmacokinetics; Q3W, every 3 weeks; TTR, time to response. 4 Li Zhang I Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302) --- [Slide 2] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -07 min 07s 2026 on Lung Cancer SEOUL, REPUBLIC OF KOREA Tumor Response by Investigators Tam-Peli significantly improved ORR vs. topotecan 420 400 Tam-Peli Topotecan 140 Tam-Peli (N = 225) (N = 226) 120 100 CR, n. (%) 0 0 80 60 PR, n (%) 133 (59.1) 22 (9.7) 40 BOR SD, n (%) 72 (32.0) 93 (41.2) 20 0 PD, n (%) 15 (6.7) 80 (35.4) -20 Best Percentage Change from baseline NE, n (%) 5 (2.2) 31 (13.7) -40 -60 Percentage 59.1 9.7 in target targetlesion lesion size -80 cORR (95% CI) (52.4, 65.6) (6.2, 14.4) -100 420 P-value <0.0001 400 140 Topotecan DCR Percentage 91.1 50.9 120 100 (95% CI) (86.6, 94.5) (44.2, 57.6) 80 Median, months 6.3 7.8 60 DoR 40 (95% CI) (6.0, 8.0) (3.3, 9.9) 20 0 Median, months 1.5 2.6 TTR -20 (range) (1.1, 4.5) (1.4, 4.8) -40 -60 Data cut-off May 20. 2026 BOR, best overall response: CI, confidence interval; cORR, confirmed objective response rate; -80 Best Objective Response: PR SD PD NE CR, complete response; DCR, disease control rate; DoR, duration of response; NE, not evaluable; -100 PD, progressive disease; PR, partial response; SD, stable disease; TTR, time to response. 12 Li Zhang I Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302) --- [Slide 3] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -06 min 31s on Lung Cancer SEOUL, REPUBLIC OF KOREA Progression-Free Survival by Investigators Tam-Peli demonstrated statistically significant and clinically meaningful improvement in PFS vs. topotecan, with a 71% reduction in rate of disease progression or death 100% Tam-Peli Topotecan (N = 225) (N = 226) 80% Probability (%) of PFS 58.1% PFS events, n (%) 134 (59.6) 179 (79.2) 60% Median PFS, 7.4 2.8 40% months (95% CI) (6.1,7.6) (1.8, 3.0) 17.9% 20% + + Censored Tam-Peli Topotecan HR 0.29 (95% Cl: 0.23, 0.37) 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 P <0.0001 Time (Months) No. at risk: Time (Months) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Tam-Peli 225 220 196 174 167 136 105 91 36 33 14 14 4 3 1 1 1 0 Topotecan 226 198 113 80 67 41 26 21 11 9 7 6 3 1 1 1 1 0 Data cut-off: May 20, 2026. Median follow-up of PFS was 7.8 months for Tam-Peli and 8.4 months for topotecan. CI, confidence interval; HR, hazard ratio (stratified); PFS, progression-free survival. 10 Li Zhang | Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302) --- [Slide 4] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -05 min 29s on Lung Cancer SEOUL, REPUBLIC OF KOREA Overall Survival Tam-Peli demonstrated statistically significant and clinically meaningful improvement in os vs. topotecan, with a 54% reduction in rate of death 100% Tam-Peli Topotecan (N = 225) (N = 226) 80% Probability (%) of survival OS events, n (%) 76 (33.8) 124 (54.9) 60% Median OS, 13.3 9.4 40% months (95% CI) (12.1, NE) (7.7, 10.5) 20% + + Censored Tam-Peli Topotecan HR 0.46 (95% Cl: 0.35, 0.62) 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 P <0.0001* Time (Months) No. at risk: Time (Months) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Tam-Peli 225 223 222 219 211 204 194 171 126 88 64 48 30 18 12 3 2 0 0 Topotecan 226 224 213 197 179 164 147 122 97 65 44 27 17 11 7 5 2 1 0 Data cut-off: May 20, 2026. Median follow-up of OS was 9.2 months for Tam-Peli and 9.5 months for topotecan. . compared with a=0.0075, which is calculated based on actual number of os events observed (200). CI, confidence interval; HR, hazard ratio (stratified); NE, not estimable; OS, overall survival 8 Li Zhang I Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302)
Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu
TAISHAN-302 — shared slides
WCLC 2026 · 2026-09-13
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[Slide 1] ASLC 2026 World Conference on Lung Cancer I SEPTEMBER 12 - 15, 2026 I SEOUL, REPUBLIC OF KOREA KALC SCIENCE WITHOUT BOUNDARIES: UNITING THE WORLD AGAINST THORACIC CANCER --- [Slide 2] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -02 min 24s on Lung Cancer SEOUL, REPUBLIC OF KOREA TAISHAN-302 Study Design A multicenter, randomized, open-label, phase 3 study (NCT06612151) Treatment until disease progression per RECIST v1.1 or intolerable toxicity. Crossover between arms is not permitted. Primary endpoint: Key eligibility criteria: OS Tam-Peli Histologically or cytologically 2.0 mg/kg, D1 Q3W, Key secondary endpoints: confirmed SCLC maximum dose of 200 mg PFS by investigators R ORR by investigators Progressed after 1 prior line of platinum-based therapy 1:1 Other secondary endpoints: Topotecan DCR, DoR, TTR by investigators At least one measurable lesion per RECIST v1.1 N=451 Safety, PK, and immunogenicity 1.2 mg/m², D1-5 Q3W* ECOG PS 0-1 Exploratory endpoints: Intracranial efficacy Stratification factors Disease status (local" or systemic disease) Brain metastasis (yes or no) Chemotherapy-free interval (<90 or >90 days) Per the prescribing enformation approved in China " Patients with local driend defined as those initially diagnosed with Inded viage disease who developed local recumence within 6 months after pârlinum based pkm definitive radiotherapy D. day. DCR disease control rate DoR duration of response COOG PS. Eastom Cooperative Oncology Group performance status, ORR, objective response - OS, overall united PFS progression from united PK, phamacokinetics, Q3W every 3 WORKS, TTR time to response 4 Li Zhang I Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302) --- [Slide 3] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -04 min 35s on Lung Cancer SEOUL, REPUBLIC OF KOREA Patient Disposition 451 patients randomized FPI: Dec 17, 2024 LPI: Oct 26, 2025 225 assigned to 226 assigned to Tam-Peli arm (ITT) Topotecan arm (ITT) 1 treatment discontinued 9 treatment discontinued 224 treated with 217 treated with Tam-Peli (SS) Topotecan (SS) 153 treatment discontinued 209 treatment discontinued 104 Disease progression per RECIST v1.1 153 Disease progression per RECIST v1.1 19 Patient decision 31 Patient decision 16 Adverse event 6 Adverse event 6 Clinical disease progression 7 Clinical disease progression 6 Death 6 Death 2 Others 6 Others 71 treatment ongoing 8 treatment ongoing Data cut-off: May 20, 2026. Median follow-up was 9.2 months (95% Cl: 8.8, 10.2) for Tam-Peli and 9.5 months (95% Cl: 8.9, 10.1) for topotecan. FPI, first patient in; ITT, intent-to-treat set; LPI, last patient in, RECIST, Response Evaluation Criteria in Solid Tumors; SS, safety set. 6 Li Zhang Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302) --- [Slide 4] IASLC 2026 World Conference SEPTEMBER 12 - 15, 2026 -05 min 20s on Lung Cancer SEOUL, REPUBLIC OF KOREA Baseline Characteristics Tam-Peli Characteristic, n (%) Topotecan (N = 225) (N = 226) Median (range), years 62.0 (28, 74) 62.0 (18, 75) Age ≥ 65 88 (39.1) 77 (34.1) Male 183 (81.3) 191 (84.5) Sex Female 42 (18.7) 35 (15.5) 0 39 (17.3) 27 (11.9) ECOG PS 1 186 (82.7) 199 (88.1) Current or former 162 (72.0) 158 (69.9) Smoking history Never 63 (28.0) 68 (30.1) Chemotherapy 225 (100) 226 (100) Immunotherapy 194 (86.2) 199 (88.1) Prior therapy Target therapy 13 (5.8) 19 (8.4) Other 5 (2.2) 5 (2.2) Local disease* 7 (3.1) 10 (4.4) Disease stage at enrollment Systemic disease 218 (96.9) 216 (95.6) ≥ 90 days 115 (51.1) 116 (51.3) Chemotherapy-free interval < 90 days 110 (48.9) 110 (48.7) Brain 78 (34.7) 77 (34.1) Metastases Liver 72 (32.0) 80 (35.4) ≥ 3 distant metastatic sites" 86 (42.0) 77 (36.2) * Patients with local disease defined as those initially diagnosed with limited-stage disease who developed local recurrence within 6 months after platinum-based chemotherapy plus definitive radiotherapy ** Percentages are based on the number of patients who have metastases. ECOG PS, Eastern Cooperative Oncology Group performance status. 7 Li Zhang I Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302)

What Physicians Said

Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙#WCLC26 #LCSM Plenary Session 🔥TAISHAN-302: Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study 🎙️Dr. Li Zhang 🎯PFS HR 0.29 (95% CI 0.23-0.37) 🎯OS HR 0.46 (95% CI 0.35-0.62) 🔢PL02.03 ☑️NCT06612151 🔗 https://t.co/JvkpEBLlSo @OncoAlert @Larvol @IASLC

👀 3,9502026-09-13
Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

Dr. Li Zhang presents results from TAISHAN-302: phase III study of tambotatug pelitecan (tam-peli, YL201), a B7-H3 antibody drug conjugate (topo-1 payload, DAR 8) vs topotecan in relapsed SCLC at #WCLC26. Included pts with SCLC progressed after 1 line of platinum-based chemotherapy with a 1:1 randomization to tam-peli 2mg/kg q3w vs standard topotecan. Median f/u ~9m and 71 pts in tam-peli arm still on therapy (vs 8 with topotecan). Note that almost 30% of pts with no smoking history - a pattern we are seeing in ES-SCLC as well. Biology shifting...

👀 3,5562026-09-13
ilyas sahin, MD
ilyas sahin, MD@ilyassahinMD

Small-cell lung cancer is an aggressive cancer that often comes back after initial treatment. In phase 3 TAISHAN-302, tambotatug pelitecan (Tam-Peli) beat the standard chemotherapy topotecan: • Survival: 13.3 vs 9.4 months • PFS: 7.4 vs 2.8 months • Response: 59% vs 10% • Grade ≥3 side effects: 55% vs 78% Longer survival, much higher response, and less severe toxicity ; a striking result in relapsed SCLC. N=451. Interim analysis.

👀 3,0942026-09-13
Noemi Reguart
Noemi Reguart@NReguart

What a day for #SCLC! Two positive phase III ADC trials today at #WCLC26 ARTEMIS-008 and TAISHAN-302— and this may be just the beginning. Look at the pipeline 👇 The ADC era has finally arrived in SCLC. Bye bye, topotecan! 🚀 https://t.co/fjXfmHC7KL

👀 2,9732026-09-13
Masahiro TORASAWA, MD. PhD.
Masahiro TORASAWA, MD. PhD.@M_Torasawa

#WCLC26 | TAISHAN-302 (1st interim) 📚 Simultaneously published in NEJM https://t.co/iyQXEIkVmA 🧬 Ph3: Tam-Peli (YL201), a B7-H3 ADC, vs topotecan in relapsed SCLC after 1 prior platinum line (n=451; ~87% prior IO) 🏆 OS: 13.3 vs 9.4 mo; HR 0.46 (95% CI 0.35–0.62, p<0.0001) 📉 PFS: 7.4 vs 2.8 mo; HR 0.29 🎯 cORR: 59.1% vs 9.7% 🧠 Intracranial activity: • PFS: 6.1 vs 4.2 mo; HR 0.43 • cORR: 32.4% vs 2.9% 🛡️ G≥3 TRAEs: 46.4% vs 74.7% ILD/pneumonitis: 4.9% vs 1.4%; no G4/5 👉 Marked OS/PFS benefit with systemic and CNS activity. Tam-Peli is a potential new standard for relapsed SCLC.

👀 2,5472026-09-13
Dr Rishabh Jain
Dr Rishabh Jain@DrRishabhOnco

🚨 TAISHAN-302 | A major new option in relapsed SCLC Phase 3 data in NEJM: Tambotatug pelitecan (Tam-Peli), a B7-H3–targeted ADC, significantly outperformed topotecan after platinum-based therapy. 451 patients randomized 1:1 📌 Overall survival 13.3 vs 9.4 months HR 0.46 | P<0.001 📌 PFS 7.4 vs 2.8 months HR 0.29 | P<0.001 📌 ORR 59.1% vs 9.7% 📌 Grade ≥3 AEs 55.4% vs 77.9% Notably, intracranial response was 32% vs 3% in patients with baseline brain lesions. Why it matters: A B7-H3 ADC has now delivered a substantial survival benefit in a randomized phase 3 SCLC trial, with markedly improved response and PFS over topotecan. Limitations: Open-label study, investigator-assessed PFS/response, and enrollment restricted to China. Clinical verdict: Tam-Peli could become an important new second-line option for relapsed SCLC, adding a mechanistically distinct alternative alongside emerging DLL3-directed therapy. @ASCO @oncoalert #LCSM #SCLC #LungCancer

👀 2,3922026-09-13

About the TAISHAN-302 Trial

Relapsed small-cell lung cancer after first-line platinum-immunotherapy has been topotecan territory for two decades, with modest benefit. TAISHAN-302 is the first phase III study of an antibody-drug conjugate to demonstrate statistically significant and clinically meaningful OS, PFS and ORR improvements over topotecan in this setting, per the investigators' presented conclusions. Tambotatug pelitecan (YL201, RG6919) targets B7-H3, broadly expressed on SCLC; MediLink Therapeutics developed it on its TMALIN linker platform, and Roche licensed it in January 2026 for development and commercialization worldwide outside mainland China, Hong Kong and Macau, with plans to rapidly initiate global trials.

The WCLC 2026 debate centered on sequencing: the same Presidential Symposium carried ARTEMIS-008, a second positive phase III B7-H3 ADC readout in the same setting, and physicians immediately asked how the class fits against DLL3-directed therapy in second line. The enrollment was conducted in China; global applicability was a live discussion point in the KOL threads.

Trial Methodology & Results

Study Design

Phase III, randomized 1:1, open-label: Tam-Peli monotherapy vs topotecan, relapsed SCLC after platinum-based therapy. N=451, interim analysis. (NEJM; WCLC26 LBA 1840)

Population

Relapsed SCLC after prior platinum-based therapy (second line); enrolled in China. (NEJM; KOL discussion)

Endpoints

OS, PFS, ORR and safety; benefit reported regardless of baseline metastasis status or chemotherapy-free interval. (IASLC press release)

Presenter

Prof. Li Zhang — WCLC 2026 Presidential Symposium, LBA 1840; simultaneous NEJM publication.

Overall survival

Median OS was 13.3 vs 9.4 months in favor of tambotatug pelitecan, HR 0.46 (95% CI 0.35–0.62, p<0.0001 per KOL slide capture) — a 54% reduction in the risk of death at the interim analysis (DCO 20-May-2026 per the presented slides; median follow-up 9.2 months). (NEJM; WCLC 2026 presented slides on this page)

OS 13.3 vs 9.4 mo · HR 0.46
Source: NEJM / WCLC 2026 LBA 1840 ↗

PFS, response and safety

PFS HR 0.29 (95% CI 0.23–0.37), median PFS 7.4 vs 2.8 months — a 71% reduction in the risk of progression — with ORR 59.1% vs 9.7% (Roche media release). Grade ≥3 adverse events occurred in 55% vs 78% (treatment-related Gr≥3 46.4% vs 74.7%); the trade-off to watch is ILD/pneumonitis at 4.9% vs 1.4% with the ADC. (WCLC 2026 presented slides on this page, DCO 20-May-2026; NEJM; Roche media release)

PFS HR 0.29 · Gr≥3 AEs 55% vs 78%
Source: WCLC 2026 presentation slides (KOL capture) ↗

WCLC 2026: Live KOL Reaction

Physician posts about this trial captured live during the IASLC 2026 World Conference on Lung Cancer (Seoul, September 12–15). Quotes are verbatim; each card links to the original post. Last updated 2026-09-15.

Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

We now have TWO studies showing B7-H3 ADCs vastly superior to standard topotecan for relapsed SCLC: tam-peli and ris-rez. These studies were different - different agents, different baseline demographics of pts, etc - but the outcomes were similar, control arms performed similarly. These trials reinforce each other. Looking forward to global studies and to first-line studies. The ADC era soundly here for SCLC and these will replace chemotherapy across lines, in my opinion. #WCLC26

9.5K impressions5 likes2026-09-13
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙#WCLC26 #LCSM Plenary Session 🔥TAISHAN-302: Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study 🎙️Dr. Li Zhang 🔢PL02.03 ☑️NCT06612151 🔗 https://t.co/icbDk1Zjnh @OncoAlert @Larvol @IASLC https://t.co/wIe6rP3BaM

2.6K impressions8 likes2026-08-20
Dr Amol Akhade
Dr Amol Akhade@SuyogCancer

TAISHAN 302 trial . HR of 0.29. Tam- Peli ( B7-H3 directed ADC ) vs Topotecan . Looks to be new SOC for second line SCLC ?? . How to put it in era of DLL3 targeting drugs ? @IASLC @StephenVLiu @RManochakian @OncoAlert @OncBrothers https://t.co/VGjzqbpd4P

2.2K impressions29 likes2026-09-13
Rami Manochakian MD, FASCO
Rami Manochakian MD, FASCO@RManochakian

🚨🔥@OncoAlert Hot off the press. Just published @NEJM in conjunction with presentation @IASLC #WCLC26. ⭐️Results of #TAISHAN302 phase 3 trial of: #Tambotatug pelitecan (B7-H3 #ADC) vs #Topotecan in patients with #SmallCell #LungCancer after progression on 1st line platinum-based therapy. #Impressive results for #Tambotatug pelitecan: ✅⬆️ #mOS: 13.3 vs 9.4 months (#HR: 0.46) ✅⬆️ #mPFS: 7.4 vs 2.8 months (#HR: 0.46) ✅⬆️ #RR: 59.1% vs 9.7% ✅⬇️#Toxicity (≥ grade 3 # AEs: 55.4% vs. 77.9%) 👇🏻 https://t.co/avqw9sYa6v

1.8K impressions2 likes2026-09-13
Dr Rishabh Jain
Dr Rishabh Jain@DrRishabhOnco

TAISHAN-302 🔥 Tam-Peli vs topotecan in relapsed SCLC: OS: 13.3 vs 9.4 mo HR 0.46 | P<0.001 A 54% reduction in risk of death with a B7-H3 ADC. This is more than a response signal. This is a survival win. @ASCO @oncoalert #SCLC #LCSM https://t.co/nxI3dRkkvT https://t.co/gq4wFZWvEi

1.6K impressions6 likes2026-09-13
gilberto lopes
gilberto lopes@GlopesMd

Major positive #WCLC26 result in relapsed SCLC: TAISHAN-302. Tambotatug pelitecan (Tam-Peli) vs topotecan: • OS 13.3 vs 9.4 mo, HR 0.46 • PFS 7.4 vs 2.8 mo, HR 0.29 • ORR 59.1% vs 9.7% • intracranial response 32% vs 3% • grade 3+ AEs 55.4% vs 77.9% My take: a major positive randomized phase 3 trial and a potential new 2L option in SCLC. Important caveat: this was a China-only study, so broader global validation still matters. Sequencing vs tarlatamab also remains an open question. #LungCancer #SCLC #ThoracicOncology #ClinicalTrials

1.5K impressions1 likes2026-09-13
Laura Alder, MD
Laura Alder, MD@LauraAlderMD

Another ADC joins the SCLC armamentarium! Tam-Peli with huge OS, PFS and intracranial benefit over topotecan!! #WCLC26. Wonderful to have more options. Optimal choice of agent(s), sequencing, and resistance are areas of future investigation. @IASLC @SclcSMASHERS @drshieldsmd https://t.co/78orgwEKGA

1.2K impressions13 likes2026-09-13
Miguel Gonzalez Velez, MD
Miguel Gonzalez Velez, MD@mgonzalezvelMD

TAISHAN-302 (Zhang L, et al) and ARTEMIS-008 (Wang J, et al) #WCLC26 @IASLC discussion by @Annechiangmd Take: Both phase 3 trials hit their primary OS endpoint vs topotecan with the same HR (0.46). TAISHAN-302: mOS 13.3 mo at 9.2 mo follow-up. ARTEMIS-008: mOS 18.5 mo at 12.2 mo follow-up. ILD/pneumonitis is the key safety. Cross-trial caveats are real: Chinese-only population, ~30% non smokers. IMO the activity should be similar in non Chinese. #SCLC #LCSM

1.0K impressions1 likes2026-09-13
Yago Garitaonaindía
Yago Garitaonaindía@YGaritaonaindia

🔥Waking up with another milestone in #SCLC coming from #WCLC26 🔵 @NEJM TAISHAN-302: B7-H3 ADC Tam-Peli vs topotecan after platinum ± IO (n=451, China). ➡️mOS 13.3 vs 9.4 mo (HR 0.46) mPFS 7.4 vs 2.8 (HR 0.29) ORR 59% vs 10% G≥3 AEs 55% vs 78% 💡OS ~tarlatamab, different mechanism 🤚China-only, open-label, short FU. @OncoAlert @oncodaily #LCSM

1.0K impressions1 likes2026-09-13
Dr. Antonio Calles 🫁🚭
Dr. Antonio Calles 🫁🚭@Tony_Calles

Tam-Peli, an anti-B7-H3 antibody-drug conjugate, versus topotecan in relapsed SCLC: A randomized, open-label, phase 3 study (TAISHAN-302): Impresive efficacy and better tolerability with low ILD incidence. Quite robust data in Chinese population. Eager to see global data soon!! #WCLC26 #LCSM @IASLC

856 impressions3 likes2026-09-13
Misty Dawn Shields
Misty Dawn Shields@drshieldsmd

Dr. Li Zhang presents the TAISHAN-302 Phase 3 study of Tam-Peli B7-H3 ADC (YL201) following at least one line of therapy compared to topotecan for ES-SCLC at @iaslc #WCLC26. Significant improvement in OS, PFS, ORR, and intracranial disease control. ILD 4.9% with YL201. This represents the Phase 3 with a B7-H3 ADC with improvement in outcomes over topotecan, however China only study. Publication is now available in NEJM today. It will be of great interest to understand how multiple B7-H3 available in pipelines will be of value to our patients impacted by SCLC globally. @SclcSMASHERS @LUNGevity @LungCancerEu @Lung_Cancers @OncoAlert @OncLive @StephenVLiu @lungoncdoc @RManochakian @OncBrothers

842 impressions5 likes2026-09-13
Uğur Özkerim
Uğur Özkerim@UOzkerim

TAISHAN-302 at #WCLC26 In patients with relapsed SCLC, the B7-H3 ADC Tam-Peli significantly improved OS versus topotecan. Median OS: 13.3 vs 9.4 months HR 0.46 (95% CI 0.35–0.62), P<0.0001 A 54% reduction in the risk of death with Tam-Peli. #SCLC #LungCancer @OncoAlert @weoncologists @OpenMedKate @ManuelDomine

750 impressions4 likes2026-09-12
Tom Newsom-Davis
Tom Newsom-Davis@tnewsomdavis

TAISHAN-302 Tam-Peli (B7H3 ADC) 2L SCLC Ph3, open label, v Topo ✅🔼OS 13 v 9m, HR 0.46 ✅🔼PFS HR 0.29 ✅🔼ORR 59 v 9% ✅🔼icRR 32 v 2% ✅🔽TRAEs 🤔 Remarkable efficacy Unprecedented OS in 2L SCLC Atypical SCLC popn, China only 💥A new SoC emerging Activity in 1L? #WCLC26 https://t.co/lrdMlnpGuU

732 impressions2 likes2026-09-13
Jennifer A. Marks, MD
Jennifer A. Marks, MD@jennifermarksmd

Always love to see a drug beating topotecan. For #sclc. Tam-Peli (B7-H3 ADC) vs topotecan showed OS benefit (13.3 m vs 9.4 m, HR 0.46) with CNS efficacy. Safety profile seems a bit intense. High number of grade 3 or higher, most commonly hematologic. @IASLC #WCLC26 #ADC #lcsm https://t.co/4lQvjaAbjy

603 impressions2 likes2026-09-13
Dr. Estela Rodriguez
Dr. Estela Rodriguez@Latinamd

🔥 #WCLC26 #TAISHAN-302 🎯Tam-Peli (YL201), a B7-H3 ADC, vs topotecan in relapsed SCLC: ▶️ OS: 13.3 vs 9.4 mo; HR 0.46 ▶️ PFS: 7.4 vs 2.8 mo; HR 0.29 ⬆️ ORR: 59.1% vs 9.7% ⚠️Grade ≥3 TRAEs: 46.4% vs 74.7% ➡️An impressive 54% reduction in death and 71% reduction in progression but topitecan is a low bar and current landscape in the US includes tarlatamab ➡️Safety appears favorable vs topotecan with fewer grade ≥3 TRAEs, but Tam-Peli has important ADC-specific toxicities that require monitoring. @SclcSMASHERS @IASLC @OncoAlert #lcsm

589 impressions0 likes2026-09-13
Dr Riyaz Shah
Dr Riyaz Shah@DrRiyazShah

ARTEMIS-008; Ris-Rez B7-H3 ADC; P3 RCT in relapsed SCLC v topo; n461; 87% ES-SCLC; WOW OS HR 0.46 in all subgroups :ORR 13%v 58%; ILD in 12% (4.9% in Tam-Peli TAISHAN 302);Await ex China global trial #WCLC26 https://t.co/HaS3TbnIH7

588 impressions4 likes2026-09-13
Elvina Almuradova
Elvina Almuradova@Dr_ElvinaA

Published simultaneously with #WCLC26 in @NEJM: TAISHAN-302 shows markedly outperformed topotecan in relapsed SCLC after platinum therapy: • OS: 13.3 vs 9.4 mo (HR 0.46) • PFS: 7.4 vs 2.8 mo (HR 0.29) • ORR: 59.1% vs 9.7% • Gr ≥3 AEs: 55.4% vs 77.9% @OncoAlert @Larvol #sclc https://t.co/vTjYTKGn4U

531 impressions0 likes2026-09-13
OsmanKostekMD
OsmanKostekMD@OncologyMarwarD

#WCLC26 | TAISHAN-302 vs ARTEMIS-008 Two B7-H3 ADCs, identical OS HR 0.46 vs topotecan. Ris-Rez: mOS 18.5 mo; Tam-Peli: 13.3 mo, but cross-trial comparison is confounded by baseline risk. Class effect clear; winner still unknown.@OncoAlert https://t.co/0eIjOWzhat

421 impressions0 likes2026-09-13
Roberto Borea, MD
Roberto Borea, MD@RobertoBoreaMD

Terrific discussion by #AnneChang at #WCLC2026 on ADCs in SCLC @IASLC TAISHAN-302 and ARTEMIS-008 both show clear OS/PFS benefit over topotecan, pointing to a possible new standard. Manageable toxicity overall Looking forward a bright ADC future 💡 https://t.co/NKTnmMi1pL

404 impressions1 likes2026-09-13
MV Chandrakanth
MV Chandrakanth@ChandrakanthMv

Two B7-H3 ADCs. Two positive phase 3 trials. One striking signal in relapsed SCLC. At WCLC 2026, TAISHAN-302 and ARTEMIS-008 both showed a major OS benefit over topotecan — remarkably, with an OS HR of 0.46 in each trial. • TAISHAN-302 — Tam-Peli: OS 13.3 vs 9.4 mo; PFS 7.4 vs 2.8 mo; ORR 59.1% vs 9.7% • ARTEMIS-008 — Ris-Rez: OS 18.5 vs 10.3 mo; PFS 7.2 vs 3.0 mo; ORR 58.3% vs 12.6% Both also showed substantially less grade ≥3 thrombocytopenia than topotecan. Important: this is a cross-trial comparison only. Different populations, study conduct and safety definitions mean we should not infer superiority of one ADC over the other. B7-H3 has arrived in relapsed SCLC. WCLC 2026 • PL02.03 TAISHAN-302 • PL02.04 ARTEMIS-008 #MVOnco #SCLC #B7H3 #ADC #LungCancer #WCLC2026 #Oncology #ThoracicOncology

373 impressions0 likes2026-09-13
Prof Tom John
Prof Tom John@TommyJohn00

Phase III Artemis study with Riz-Rez. Different ADC, same target. Almost the same results as TAISHAN-302. #LCSM #WCLC2026 https://t.co/apA8LMgsEa

298 impressions3 likes2026-09-13
Diego A. Díaz-García
Diego A. Díaz-García@diegoadiazg

🫁 A new second-line option for relapsed SCLC. #wclc26 TAISHAN-302 showed a major survival benefit with the B7-H3 ADC tambotatug pelitecan (YL201) vs topotecan: • OS: 13.3 vs 9.4 months, HR 0.46 • PFS: 7.4 vs 2.8 months, HR 0.29 • ORR: 59.1% vs 9.7% • Grade ≥3 TRAEs: 46.4% vs 74.7% OS benefit was consistent across subgroups, including brain and liver metastases and CTFI <90 days. #CánCare #SCLC #LungCancer #ThoracicOncology #ADC #B7H3

260 impressions1 likes2026-09-13
Paul H, PharmD, RPH
Paul H, PharmD, RPH@phsiao4

TAISHAN-302 is a randomised, open-label phase III study evaluating the efficacy and safety of Tam-Peli (2.0 mg/kg intravenously on day 1 of each 21-day cycle, maximum dose 200 mg) compared with topotecan in patients with small-cell lung cancer (SCLC) https://t.co/EUmSduaGr6

35 impressions1 likes2026-09-13
Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

Results from phase III TAISHAN-302 study showing massive OS benefit of tam-peli over topotecan in relapsed SCLC @NEJM after #WCLC26 presidential. https://t.co/YK8fg3VK7w

2.3K impressions6 likes2026-09-13
gilberto lopes
gilberto lopes@GlopesMd

Two B7-H3 ADCs presented at #WCLC26 produced very encouraging results in relapsed SCLC: ARTEMIS-008 (Ris-Rez) and TAISHAN-302 (Tam-Peli). We put them side by side in a descriptive cross-trial comparison. https://t.co/yjHAxmq7S1

1.3K impressions1 likes2026-09-13
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙 #WCLC26 #LCSM Mini Oral Session 🔥 First-Line YL201 Plus Serplulimab in ES-SCLC and Advanced NSCLC: Phase 1 Results of a B7-H3-Directed Combination Strategy 🎯ES-SCLC: cORR 85.4%, DCR 92.7%, mPFS 12.9 mo 🎯Non-AGA NSQ-NSCLC: cORR 58.3% 🎯Squamous NSCLC: cORR 57.9% 🎯Grade≥3 TRAEs 38.8% 🎙️ Dr. H. Zhao 🔢 MO15.04 ☑️ NCT06394414 🔗 https://t.co/RyAjeLYzZC @OncoAlert @Larvol @IASLC

986 impressions7 likes2026-09-01
Misty Dawn Shields
Misty Dawn Shields@drshieldsmd

Dr. Jie Wang presents the ARTEMIS-008 Phase 3 results of Ris-Rez compared to topotecan in 2L+ ES-SCLC at @iaslc #WCLC26. Ris-Rez significantly improved OS, PFS, and ORR. ILD rate 11.7%. Fewer patients with platinum resistant disease (<90d) compared to Tam-Peli. Similar to YL201, China only study, but this study again demonstrates OS improvement over topotecan with a B7-H3 ADC. While highly effective initially, ADCs are prone to acquired resistance and cumulative myelosuppression that need to be proactively addressed. @SclcSMASHERS @LUNGevity @lungoncdoc @StephenVLiu @RManochakian @LauraAlderMD @NaglaAKarimMD @BrunaPellini @LungCancerEu @OncodailyLung @OncoAlert @OncLive

813 impressions3 likes2026-09-13
Dr Amol Akhade
Dr Amol Akhade@SuyogCancer

ADC have arrived in second line SCLC . Many options for patients now. Rapidly evolving field . Nice discussion to summarize both Taishan-302 and Artemis 008 . @IASLC @StephenVLiu @FordePatrick @CharuAggarwalMD @DrRiyazShah @LauraAlderMD https://t.co/Xm9cOOk6cO

677 impressions6 likes2026-09-13
Dr Riyaz Shah
Dr Riyaz Shah@DrRiyazShah

Tam-Peli B7-H3 ADC; TAISHEN-302 P3RCTin relapse v topo ; open label; n451; median FU 9m; largely ES-SCLC; WOW OS curve in all subgroups; PFS HR 0.29! ;OSS 10% v 59%!; less toxic than chemo. I shan’t miss topotecan #WCLC26 https://t.co/HgRIvCE5jR

413 impressions2 likes2026-09-13
MV Chandrakanth
MV Chandrakanth@ChandrakanthMv

TAISHAN-302: B7-H3 enters the phase III SCLC arena. In relapsed SCLC after platinum-based therapy, tambotatug pelitecan (Tam-Peli) — a B7-H3–targeting ADC — beat topotecan across the major efficacy endpoints: OS: 13.3 vs 9.4 mo | HR 0.46 PFS: 7.4 vs 2.8 mo | HR 0.29 ORR: 59.1% vs 9.7% Grade ≥3 AEs: 55.4% vs 77.9% An encouraging intracranial signal was also seen: 32% vs 3% response, although this was exploratory. The message is bigger than response rate: this was an OS-positive randomized phase III trial. The next question may be just as important: where should a B7-H3 ADC sit alongside DLL3-directed tarlatamab? No head-to-head comparison yet. #MVOnco #TAISHAN302 #SCLC #LungCancer #B7H3 #ADC #TambotatugPelitecan #ThoracicOncology Reference: Zhao Y, et al. N Engl J Med. 2026. DOI: 10.1056/NEJMoa2610229.

371 impressions1 likes2026-09-13
Prof Tom John
Prof Tom John@TommyJohn00

TAISHAN-302, Li Zhang - potentially practice changing study in #SCLC. Topotecan is a crap drug, be good to see the end of it. Where this fits given Tarla data as maintenance also unclear. Suspect it will all come down to access. #LCSM #WCLC2026 https://t.co/yb5Gw4h4yl

339 impressions1 likes2026-09-13
Elvina Almuradova
Elvina Almuradova@Dr_ElvinaA

#WCLC26 – A turning point for relapsed #SCLC? Two B7-H3 ADC trials vs topotecan: -TAISHAN-302: OS 13.3 vs 9.4mo (HR 0.46), ORR 59.1% vs 9.7% -ARTEMIS-008: OS 18.5 vs 10.3mo (HR 0.46), PFS 7.2 vs 3.0mo (HR 0.33) Big signals — potential new standard emerging @OncoAlert @Larvol https://t.co/jenXMESTTV

256 impressions1 likes2026-09-13
Dr. Estela Rodriguez
Dr. Estela Rodriguez@Latinamd

#WCLC26 Simultaneous publication @NEJM 👉🏽Tambotatug Pelitecan in Small-Cell Lung Cancer after Platinum-Based Therapy | New England Journal of Medicine https://t.co/yOjmmyWNVC

231 impressions3 likes2026-09-13
Roberto Borea, MD
Roberto Borea, MD@RobertoBoreaMD

TAISHAN-302: Phase 3 trial of Tam-Peli (B7-H3 ADC) vs topotecan in relapsed SCLC (N=451) after platinum therapy. OS: 13.3 vs 9.4 months (HR 0.46), 54% reduction in risk of death. Safety profile favorable and manageable #WCLC26 @IASLC https://t.co/4wJT1Pjpnv

185 impressions0 likes2026-09-13
OsmanKostekMD
OsmanKostekMD@OncologyMarwarD

#WCLC26 | ARTEMIS-008 Ris-Rez improved OS (18.5 vs 10.3 mo; HR 0.46) and PFS (7.2 vs 3.0 mo; HR 0.33) vs topotecan in relapsed SCLC. Another strong phase III signal for B7-H3 ADCs. How should we interpret this alongside TAISHAN-302? https://t.co/VRYS2dQXvH

119 impressions0 likes2026-09-13
Dr Rishabh Jain
Dr Rishabh Jain@DrRishabhOnco

TAISHAN-302 🔥 Tam-Peli vs topotecan in relapsed SCLC: OS: 13.3 vs 9.4 mo HR 0.46 | P<0.001 A 54% reduction in risk of death with a B7-H3 ADC. This is more than a response signal. This is a survival win. @ASCO @oncoalert #SCLC #LCSM https://t.co/gq4wFZWvEi

77 impressions0 likes2026-09-13
Miguel Gonzalez Velez, MD
Miguel Gonzalez Velez, MD@mgonzalezvelMD

TAISHAN-302 (Zhang L, et al) and ARTEMIS-008 (Wang J, et al) #WCLC26 @IASLC Take: Both phase 3 trials hit their primary OS endpoint vs topotecan with the same HR (0.46). TAISHAN-302: mOS 13.3 mo at 9.2 mo follow-up. ARTEMIS-008: mOS 18.5 mo at 12.2 mo follow-up. ILD/pneumonitis is the key safety. Cross-trial caveats are real: Chinese-only population, ~30% non smokers. IMO the activity should be similar in non Chinese. #SCLC #LCSM

19 impressions0 likes2026-09-13
Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

Dr. Li Zhang makes important clarification missed by some on TAISHAN-302: relapsed SCLC, tam peli with superior OS over topotecan. Though ~30% of patients had no smoking history, these are not transformed SCLC - those were excluded. This is a shift in SCLC biology we are seeing - and many are TP52/Rb1 intact. #WCLC26

1.3K impressions5 likes2026-09-13
gilberto lopes
gilberto lopes@GlopesMd

Quick take from #WCLC26: Tam-Peli showed a clear overall survival advantage vs topotecan on the slide presented today: Median OS: 13.3 vs 9.4 months HR: 0.46 (95% CI 0.35–0.62) P < 0.0001 Reported as a 54% reduction in the rate of death Striking OS signal. More detailed thoughts soon. @iaslc #WCLC26 @oncoalert @oncodaily @larvol @tribeMDUS @sylvestercancer @oncbrothers @chinmay @Jani_Chinmay @latinamd @colazagasti @openmedicineHQ @asco @myesmo @openmedkate @openmedben @chadinabhan @YoungLungCancer @lungoncdoc @OncodailyLung @ClinicalLung #LCSM @LungPolicy #LungCancer #SCLC #ThoracicOncology

1.2K impressions6 likes2026-09-13
OsmanKostekMD
OsmanKostekMD@OncologyMarwarD

#WCLC26 | TAISHAN-302 In relapsed SCLC, Tam-Peli (YL201) significantly improved outcomes vs topotecan: OS 13.3 vs 9.4 mo (HR 0.46), PFS 7.4 vs 2.8 mo (HR 0.29), ORR 59.1% vs 9.7%, with meaningful intracranial activity. A strong candidate for a new standard in relapsed SCLC. https://t.co/BqRdRHQ2GO

78 impressions0 likes2026-09-13
Dr. Estela Rodriguez
Dr. Estela Rodriguez@Latinamd

🔥 #WCLC26 #TAISHAN-302 🎯Tam-Peli (YL201), a B7-H3 ADC, vs topotecan in relapsed SCLC: ▶️ OS: 13.3 vs 9.4 mo; HR 0.46 ▶️ PFS: 7.4 vs 2.8 mo; HR 0.29 ⬆️ ORR: 59.1% vs 9.7% ⚠️Grade ≥3 TRAEs: 46.4% vs 74.7% ➡️An impressive 54% reduction in death and 71% reduction in progression but topitecan is a low bar and current landscape in the US includes tarlatamab ➡️Safety appears favorable vs topotecan with fewer grade ≥3 TRAEs, but Tam-Peli has important ADC-specific toxicities that require monitoring. @SclcSMASHERS @IASLC @OncoAlert #lcsm

26 impressions0 likes2026-09-13
Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

Wow. Tam-peli with a major improvement in OS over topotecan with median OS 13.3m vs 9.4m, OS HR 0.46. The curves split early, clear separation. Control arm performed as expected. Excellent outcomes in 2L setting. #WCLC26 https://t.co/kKQJPryCk9

1.0K impressions9 likes2026-09-13
gilberto lopes
gilberto lopes@GlopesMd

3/6 TAISHAN-302 Tam-peli is a B7-H3 antibody-drug conjugate being compared with topotecan in relapsed SCLC. We know: Early-phase activity has been very encouraging. We don’t yet know publicly: whether the phase III trial is positive. At WCLC: OS, PFS, response durability and toxicity — and whether B7-H3 is truly ready for prime time in SCLC.

633 impressions5 likes2026-08-21

TAISHAN-302 FAQ

What is the TAISHAN-302 trial?

TAISHAN-302 (NCT06612151) is a phase III randomized trial of tambotatug pelitecan (Tam-Peli, YL201) — an investigational B7-H3-directed antibody-drug conjugate developed by MediLink Therapeutics and licensed by Roche in January 2026 for development and commercialization outside mainland China, Hong Kong and Macau — versus topotecan in 451 patients with relapsed small-cell lung cancer after platinum-based therapy. It was presented at the WCLC 2026 Presidential Symposium (LBA 1840) and simultaneously published in the New England Journal of Medicine.

What did TAISHAN-302 show?

Median overall survival was 13.3 versus 9.4 months in favor of tambotatug pelitecan (HR 0.46), with progression-free survival HR 0.29 (95% CI 0.23–0.37), a significantly higher response rate, and fewer Grade ≥3 adverse events than topotecan (55% vs 78%). Per the investigators, it is the first phase III ADC study to show significant OS, PFS and ORR improvements over topotecan in relapsed SCLC.

Is tambotatug pelitecan approved?

No. Tambotatug pelitecan is investigational and not approved by any regulator; it holds U.S. FDA and China CDE Breakthrough Therapy Designations for relapsed SCLC. The presented conclusions describe it as a potential new standard-of-care option for second-line SCLC, pending regulatory review.

How does TAISHAN-302 relate to ARTEMIS-008?

They are separate phase III trials of two different investigational B7-H3-directed ADCs, both presented at WCLC 2026 and both positive against topotecan in relapsed SCLC: TAISHAN-302 tested tambotatug pelitecan (MediLink/Roche) and ARTEMIS-008 tested risvutatug rezetecan (Hansoh/GSK). Together they were the meeting's headline validation of the B7-H3 ADC class.

What are the limitations discussed by KOLs?

Physicians flagged the open-label design, investigator-assessed PFS and response, enrollment restricted to China, and the sequencing question versus DLL3-directed therapies such as tarlatamab — including how B7-H3 ADCs and DLL3 T-cell engagers should be ordered in second-line SCLC.

Key KOL Sentiments

KOLComment (verbatim)SentimentDate
ilyas sahin, MD
@ilyassahinMD
Small-cell lung cancer is an aggressive cancer that often comes back after initial treatment. In phase 3 TAISHAN-302, tambotatug pelitecan (Tam-Peli) beat the standard chemotherapy topotecan: • Survival: 13.3 vs 9.4 months • PFS: 7.4 vs 2.8 months • Response: 59% vs 10% • Grade ≥3 side effects: 55% vs 78% Longer survival, much higher response, and less severe toxicity ; a striking result in relapsed SCLC. N=451. Interim analysis.Positive2026-09-13
Hidehito HORINOUCHI
@HHorinouchi
🆙#WCLC26 #LCSM Plenary Session 🔥TAISHAN-302: Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study 🎙️Dr. Li Zhang 🎯PFS HR 0.29 (95% CI 0.23-0.37) 🎯OS HR 0.46 (95% CI 0.35-0.62) 🔢PL02.03 ☑️NCT06612151 🔗 https://t.co/JvkpEBLlSo @OncoAlert @Larvol @IASLCNeutral2026-09-13
Stephen V Liu, MD
@StephenVLiu
Dr. Li Zhang presents results from TAISHAN-302: phase III study of tambotatug pelitecan (tam-peli, YL201), a B7-H3 antibody drug conjugate (topo-1 payload, DAR 8) vs topotecan in relapsed SCLC at #WCLC26. Included pts with SCLC progressed after 1 line of platinum-based chemotherapy with a 1:1 randomization to tam-peli 2mg/kg q3w vs standard topotecan. Median f/u ~9m and 71 pts in tam-peli arm still on therapy (vs 8 with topotecan). Note that almost 30% of pts with no smoking history - a pattern we are seeing in ES-SCLC as well. Biology shifting...Neutral2026-09-13
Noemi Reguart
@NReguart
What a day for #SCLC! Two positive phase III ADC trials today at #WCLC26 ARTEMIS-008 and TAISHAN-302— and this may be just the beginning. Look at the pipeline 👇 The ADC era has finally arrived in SCLC. Bye bye, topotecan! 🚀 https://t.co/fjXfmHC7KLNeutral2026-09-13
Masahiro TORASAWA, MD. PhD.
@M_Torasawa
#WCLC26 | TAISHAN-302 (1st interim) 📚 Simultaneously published in NEJM https://t.co/iyQXEIkVmA 🧬 Ph3: Tam-Peli (YL201), a B7-H3 ADC, vs topotecan in relapsed SCLC after 1 prior platinum line (n=451; ~87% prior IO) 🏆 OS: 13.3 vs 9.4 mo; HR 0.46 (95% CI 0.35–0.62, p<0.0001) 📉 PFS: 7.4 vs 2.8 mo; HR 0.29 🎯 cORR: 59.1% vs 9.7% 🧠 Intracranial activity: • PFS: 6.1 vs 4.2 mo; HR 0.43 • cORR: 32.4% vs 2.9% 🛡️ G≥3 TRAEs: 46.4% vs 74.7% ILD/pneumonitis: 4.9% vs 1.4%; no G4/5 👉 Marked OS/PFS benefit with systemic and CNS activity. Tam-Peli is a potential new standard for relapsed SCLC.Neutral2026-09-13
Dr Rishabh Jain
@DrRishabhOnco
🚨 TAISHAN-302 | A major new option in relapsed SCLC Phase 3 data in NEJM: Tambotatug pelitecan (Tam-Peli), a B7-H3–targeted ADC, significantly outperformed topotecan after platinum-based therapy. 451 patients randomized 1:1 📌 Overall survival 13.3 vs 9.4 months HR 0.46 | P<0.001 📌 PFS 7.4 vs 2.8 months HR 0.29 | P<0.001 📌 ORR 59.1% vs 9.7% 📌 Grade ≥3 AEs 55.4% vs 77.9% Notably, intracranial response was 32% vs 3% in patients with baseline brain lesions. Why it matters: A B7-H3 ADC has now delivered a substantial survival benefit in a randomized phase 3 SCLC trial, with markedly improved response and PFS over topotecan. Limitations: Open-label study, investigator-assessed PFS/response, and enrollment restricted to China. Clinical verdict: Tam-Peli could become an important new second-line option for relapsed SCLC, adding a mechanistically distinct alternative alongside emerging DLL3-directed therapy. @ASCO @oncoalert #LCSM #SCLC #LungCancerNeutral2026-09-13
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Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated September 13, 2026. Every statistic carries its source label in place; every quote is verbatim from the physician's own post.