Roche/MediLink: Tam‑Peli phase III shows large survival gain in Chinese relapsed SCLC
- Tam‑Peli reduced risk of death by 54% versus topotecan (median OS 13.3 vs 9.4 months; HR=0.46).
- Tam‑Peli cut risk of progression by 71% (median PFS 7.4 vs 2.8 months; HR=0.29) and raised ORR to 59.1% vs 9.7%.
- Consistent benefits across prespecified subgroups and intracranial benefit in patients with brain metastases (intracranial PFS 6.1 vs 4.2 months; intracranial ORR 32.4% vs 2.9%).
- China CDE has accepted the NDA; Roche holds rights outside mainland China/HK/Macau and plans rapid initiation of global phase III trials; Tam‑Peli holds FDA and CDE Breakthrough Therapy designations.
Phase III primary results
Interim TAISHAN-302 data show Tam‑Peli (tambotatug pelitecan) met the primary endpoint of overall survival in a randomised phase III study in China, reducing risk of death by 54% versus topotecan (median OS 13.3 vs 9.4 months; stratified HR=0.46; p<0.0001). Key secondary endpoints were also significant: median PFS 7.4 vs 2.8 months (HR=0.29; p<0.0001) and confirmed ORR 59.1% vs 9.7% (p<0.0001).
Subgroups and intracranial activity
OS and PFS improvements were consistent across prespecified subgroups (age, chemo‑free interval, baseline liver/brain metastases). In patients with baseline brain metastases Tam‑Peli extended median intracranial PFS (6.1 vs 4.2 months; unstratified HR=0.43; 95% CI 0.27–0.68) and achieved higher intracranial response (32.4% vs 2.9%).
Safety profile
Tam‑Peli showed lower rates of Grade ≥3 treatment‑related adverse events than topotecan (46.4% vs 74.7%) and fewer serious TRAEs (25.9% vs 36.4%). All‑grade ILD/pneumonitis occurred in 4.9% versus 1.4%; grade 3 ILD was 0.9% in both arms and no grade 4–5 ILD events were reported.
Mechanism, regulatory status and next steps
Tam‑Peli is a B7‑H3‑targeted ADC built on MediLink’s TMALIN® platform with a dual‑release topoisomerase‑1 payload (DAR 8). Results were presented at WCLC 2026 and published simultaneously in The New England Journal of Medicine; China’s CDE has accepted the NDA for filing. Under a January 2026 Roche–MediLink licence, Roche holds development and commercial rights outside mainland China, Hong Kong and Macau and plans rapid initiation of global phase III trials.
Source: Roche
