TAISHAN-302 Trial Shows Tam-Peli Significantly Improves Survival in Relapsed Small-Cell Lung Cancer
News related to:International Association for the Study of Lung Cancer · 2 min read
The phase III TAISHAN-302 trial has shown that tambotatug pelitecan (Tam-Peli, YL201), an anti-B7-H3 antibody-drug conjugate, significantly improves survival outcomes for patients with relapsed small-cell lung cancer (SCLC). The study, presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC), demonstrated that Tam-Peli reduced the risk of death by 54% compared to topotecan, a long-standing standard second-line treatment.
The randomized, open-label study enrolled 451 patients, with 225 assigned to Tam-Peli and 226 to topotecan. Patients received Tam-Peli at a dose of 2.0 mg/kg intravenously on day 1 of each three-week cycle, with a maximum dose of 200 mg. The primary endpoint was overall survival, with progression-free survival and objective response rate as key secondary endpoints.
As of May 20, 2026, after a median follow-up of 9.4 months, median overall survival was 13.3 months with Tam-Peli compared to 9.4 months with topotecan. Tam-Peli also significantly improved progression-free survival, with a median of 7.4 months versus 2.8 months for topotecan. The objective response rate was 59.1% with Tam-Peli and 9.7% with topotecan.
The safety profile of Tam-Peli was generally manageable, with no new safety signals identified. Grade 3 or higher treatment-related adverse events occurred in 46.4% of patients receiving Tam-Peli compared to 74.7% receiving topotecan. There were no treatment-related deaths in the Tam-Peli arm, and treatment-emergent interstitial lung disease or pneumonitis occurred in 4.9% of patients receiving Tam-Peli and 1.4% receiving topotecan.
Professor Li Zhang of Sun Yat-sen University Cancer Center, Guangzhou, China, commented, "TAISHAN-302 is among the first phase III studies of an antibody-drug conjugate to demonstrate statistically significant and clinically meaningful improvements in overall survival, progression-free survival, and objective response rate compared to topotecan in relapsed small-cell lung cancer. Together with a generally favorable and manageable safety profile, these results support Tam-Peli as a potential new standard-of-care option for second-line SCLC and may reshape the treatment landscape for this challenging disease."
The findings of the TAISHAN-302 trial are particularly significant given the limited treatment options available for relapsed SCLC. The disease remains highly aggressive, with poor outcomes following first-line immunotherapy and platinum-based chemotherapy. Topotecan, while a standard second-line treatment, has a modest survival benefit.
The IASLC, the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies, hosted the WCLC, which attracted nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The conference aims to increase awareness, collaboration, and understanding of lung cancer and help participants implement the latest developments across the globe.
The results of the TAISHAN-302 trial underscore the potential of antibody-drug conjugates in the treatment of SCLC and may lead to changes in clinical practice. The study's findings are expected to be further discussed and analyzed at the WCLC, where they will be shared with the global medical community.