Tam-Peli extends survival by nearly four months in relapsed small-cell lung cancer

by International Association for the Study of Lung Cancer

edited by Gaby Clark, reviewed by Robert Egan

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The phase 3 TAISHAN-302 trial found that tambotatug pelitecan (Tam-Peli, YL201), a novel anti-B7-H3 antibody-drug conjugate, significantly improved overall survival, progression-free survival and objective response rate compared with topotecan in patients with relapsed small-cell lung cancer (SCLC). The findings were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).

Relapsed SCLC remains a highly aggressive disease with limited effective treatment options and poor outcomes following first-line immunotherapy and platinum-based chemotherapy. Topotecan has long been a standard second-line treatment, but its survival benefit remains modest. TAISHAN-302 evaluated Tam-Peli as a second-line treatment for patients whose SCLC had relapsed after first-line therapy.

The randomized, open-label study enrolled 451 patients, with 225 assigned to Tam-Peli and 226 to topotecan. Patients receiving Tam-Peli were treated with 2.0 mg/kg intravenously on day 1 of each 3-week cycle, with a maximum dose of 200 mg. Treatment continued until disease progression or unacceptable toxicity. The study's 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 with 9.4 months with topotecan. Tam-Peli reduced the risk of death by 54% (HR 0.46; 95% CI 0.35–0.62; p<0.0001). The survival benefit was consistent across prespecified subgroups, including patients with brain metastases, liver metastases and a chemotherapy-free interval of less than 90 days.

Tam-Peli also significantly improved progression-free survival. Median progression-free survival was 7.4 months with Tam-Peli versus 2.8 months with topotecan, representing a 71% reduction in the risk of disease progression or death (HR 0.29; 95% CI 0.23–0.37; p<0.0001). The objective response rate was 59.1% with Tam-Peli compared with 9.7% with topotecan (p<0.0001).

The safety profile of Tam-Peli was considered manageable and consistent with its known profile, with no new safety signals identified. Grade 3 or higher treatment-related adverse events occurred in 46.4% of patients receiving Tam-Peli compared with 74.7% receiving topotecan, and there were no treatment-related deaths in the Tam-Peli arm. Treatment-emergent interstitial lung disease or pneumonitis occurred in 4.9% of patients receiving Tam-Peli and 1.4% receiving topotecan; grade 3 events occurred in 0.9% of patients in each group, with no grade 4 or 5 events reported.

"TAISHAN-302 is among the first phase 3 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 with topotecan in relapsed small-cell lung cancer," said Professor Li Zhang of Sun Yat-sen University Cancer Center. "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."

Key medical concepts

TopotecanProgression-Free Survival

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OncologyPulmonary medicine Provided by International Association for the Study of Lung Cancer Who's behind this story?

Gaby Clark

MA in English, copy editor since 2021 with experience in higher education and health content. Dedicated to trustworthy science news. Full profile →

Robert Egan

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Citation: Tam-Peli extends survival by nearly four months in relapsed small-cell lung cancer (2026, September 12) retrieved 13 September 2026 from https://medicalxpress.com/news/2026-09-tam-peli-survival-months-relapsed.html This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.