Tambotatug Pelitecan Delivers Major Survival Gain in Relapsed SCLC in Phase 3 TAISHAN-302
核心洞察
The phase III TAISHAN-302 trial found tambotatug pelitecan (搜索) improved median overall survival to 13.3 months versus 9.4 months with topotecan in relapsed small-cell lung cancer (搜索).
Median progression-free survival rose from 2.8 to 7.4 months and confirmed objective response from 9.7% to 59.1% with the B7-H3 (搜索)-directed antibody-drug conjugate.
Grade 3 or higher adverse events occurred in 55.4% of tambotatug pelitecan (搜索) patients versus 77.9% with topotecan, though interstitial lung disease occurred in 4.9% versus 1.4%.
The phase III TAISHAN-302 trial, published in The New England Journal of Medicine, reports that tambotatug pelitecan (搜索) (Tam-Peli) improved overall survival, progression-free survival and objective response versus topotecan in patients with small-cell lung cancer (搜索) progressing after first-line platinum-based therapy. Median overall survival reached 13.3 months with Tam-Peli versus 9.4 months with topotecan, a hazard ratio for death of 0.46 (95% CI, 0.35-0.62; P<0.001), at a prespecified interim analysis with 200 deaths. Median PFS was 7.4 versus 2.8 months (HR 0.29; 95% CI, 0.23-0.37; P<0.001) and confirmed objective response was 59.1% versus 9.7%.
TAISHAN-302 randomized 451 patients 1:1 across 85 sites in China to Tam-Peli 2.0 mg/kg intravenously every three weeks or topotecan 1.2 mg/m2 on days 1-5 every three weeks, with no crossover permitted. Tam-Peli, formerly YL201, is a B7-H3 (搜索)-targeting antibody-drug conjugate pairing a human IgG1 anti-B7-H3 antibody via a tripeptide linker to YL0010014, a camptothecin-derived topoisomerase I inhibitor payload. Among 143 patients with baseline intracranial lesions, investigator-assessed intracranial response was 32% versus 3%, with median intracranial PFS of 6.1 versus 4.2 months.
Grade 3 or higher adverse events occurred in 55.4% of Tam-Peli patients versus 77.9% with topotecan, with lower rates of severe thrombocytopenia, anemia, leukopenia and neutropenia. Interstitial lung disease or pneumonitis occurred in 4.9% versus 1.4%; among 11 Tam-Peli cases, nine were grade 1-2 and two grade 3, with no grade 4 or 5 events. The authors note the trial was open label, enrolled entirely in China, and had median follow-up of about nine months. A phase III trial of tambotatug pelitecan (搜索) plus a PD-1 inhibitor in first-line SCLC is ongoing.
Source: OncoDaily