Multicenter phase 3 trial of tambotatug pelitecan in small cell lung cancer progressing after first-line platinum-based therapy

Tambotatug pelitecan (Tam-Peli) is a novel antibody-drug conjugate that targets the immune-checkpoint molecule B7-H13. Tam-Peli showed promising efficacy in patients with relapsed extensive-stage small cell lung cancer (SCLC) in early-phase trials. The multicenter TAISHAN-302 trial in China compared Tam-Peli with topotecan among patients with SCLC that had progressed after first-line platinum-based therapy. Patients were randomized 1:1 to receive Tam-Peli (n=225) or topotecan (n=226). The primary endpoint was overall survival (OS); secondary endpoints were investigator-assessed progression-free survival (PFS) and objective response rate (ORR). Median OS was significantly longerwith Tam-Peli than with topotecan (13.3 months versus 9.4 months; sHR 0.46; p<0.001), as was median PFS (7.4 months versus 2.8 months; 0.29; p<0.001); confirmed ORR was 59.1% versus 9.7% (pxtagstartz0.001). The overall incidence of grade 3 or higher adverse events was 55.4% with Tam-Peli and 77.9% with topotecan. The authors conclude that among patients with relapsed SCLC after first-line platinum-based therapy, treatment with Tam-Peli resulted in longer OS and PFS and higher ORR than treatment with topotecan, with a lower incidence of adverse events of grade 3 or higher.xtagstartz/p>