Roche reports interim Tam-Peli phase III survival benefit in relapsed SCLC

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Roche reports interim Tam-Peli phase III survival benefit in relapsed SCLC

clinical_trial_result2026-09-13 13:29:31 UTCimp 0.83RHHBY +0.784568.T -0.58MRK -0.50

Roche reported interim results from the randomized phase III TAISHAN-302 trial of Tam-Peli (tambotatug pelitecan, YL201) versus topotecan in Chinese patients with relapsed small-cell lung cancer. The trial met its primary overall-survival endpoint, with Tam-Peli reducing the risk of death by 54% and producing median overall survival of 13.3 months versus 9.4 months for topotecan (stratified HR 0.46; p<0.0001).

Occurred 2026-09-13 00:00:00 UTCSurprise 0.72Confidence 0.98
Rationale

The source explicitly reports a new interim randomized phase III TAISHAN-302 readout on 13 September 2026, with Tam-Peli meeting its primary overall-survival endpoint and showing a substantial mortality reduction versus topotecan. This is a forward-looking clinical development with potential regulatory, commercial, and competitive implications, not a market-performance or commentary item. The description is kept focused on the clinical-trial result; the separately stated Chinese NDA filing acceptance is treated as a related but distinct regulatory milestone. The date is explicit, but the exact time is not, so 00:00 UTC is used as a date-level estimate. Roche is directly exposed through its disclosed ex-China development, manufacturing, and commercialization rights; the approved competitor stakeholders have therapies explicitly identified in the provided context as competing in relapsed SCLC, while indirect CDMOs and less-overlapping lung-cancer programs are excluded.

EventsMediLink Tam-Peli TAISHAN-302 development in relapsed small-cell lung cancer
Evidence
Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer
globenewswire2026-09-13 00:00:00 UTCOpen source
Basel, 13 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced that its collaborator MediLink released interim results from the randomised phase III TAISHAN-302 trial evaluating Tam-Peli (tambotatug pelitecan, YL201) versus topotecan in Chinese patients with relapsed small-cell lung cancer (SCLC) who progressed after prior platinum-based chemotherapy with or without a PD-L1 inhibitor.1 The trial met its primary endpoint of overall survival (OS) with Tam-Peli demonstrating a statistically significant and clinically meaningful OS benefit, reducing the risk of death by 54% (median OS 13.3 vs. 9.4 months; stratified HR=0.46; p<0.0001).
Phase III TAISHAN-302 Trial Shows Tam-Peli Significantly Improves Survival in Relapsed Small-Cell Lung Cancer
pr newswire2026-09-13 12:57:00 UTCOpen source
Anti-B7-H3 antibody-drug conjugate reduced the risk of death by 54% versus topotecan and improved progression-free survival and response rates
The phase III TAISHAN-302 trial found that tambotatug pelitecan (Tam-Peli, YL201), a...