The Absolute Effect / Evidence / Small-Cell Lung Cancer · Medical Oncology · Relapsed disease
In SCLC progressing after first-line platinum-based therapy, does tambotatug pelitecan improve outcomes compared with topotecan?
451 patients; phase III, randomized, open-label. Tam-Peli 2.0 mg/kg IV day 1 every 21 days versus topotecan. Primary endpoint: OS.
Median OS 13.3 vs 9.4 months; HR 0.46 (95% CI 0.35–0.62; P<0.001). Median PFS 7.4 vs 2.8 months; HR 0.29 (95% CI 0.23–0.37; P<0.001). ORR 59.1% vs 9.7%: absolute increase 49.4 percentage points.
Grade ≥3 adverse events were lower with Tam-Peli in the NEJM interim analysis (55.4% vs 77.9%). ILD/pneumonitis occurred in 4.9% vs 1.4%.
Tam-Peli (YL201) is a B7-H3/CD276-directed antibody–drug conjugate. Its antibody binds B7-H3 on tumour cells, the complex is internalized, and a protease-cleavable linker releases a camptothecin-derived/topoisomerase-I inhibitor payload. The payload inhibits topoisomerase I, causing replication-associated DNA damage, cell-cycle arrest and apoptosis. The TMALIN platform also permits tumour-microenvironment activation and extracellular payload release, supporting a bystander effect.
Zhao Y, Liu H, Meng X, et al. N Engl J Med. 2026. DOI 10.1056/NEJMoa2610229.
TAISHAN-302 is newly published phase III evidence in relapsed SCLC comparing the B7-H3-directed ADC tambotatug pelitecan with topotecan. The reported OS, PFS and response advantages are substantial, but incorporation into routine care depends on regulatory approval, availability, subsequent guideline updates and confirmation of safety/benefit in the relevant jurisdiction. Do not infer local approval from publication alone. Monitor for interstitial lung disease/pneumonitis and other ADC-specific toxicity.
TAISHAN-302 primary publication ↗ · Check current trial/registration status ↗