Roche partner MediLink reports Phase III data showing Tam-Peli significantly extends survival in Chinese small-cell lung cancer patients

Roche has announced that its collaborator MediLink released interim results from the randomized Phase III TAISHAN-302 trial, which tested Tam-Peli (tambotatug pelitecan, also known as YL201) against topotecan in Chinese patients with relapsed small-cell lung cancer whose disease had progressed after prior platinum-based chemotherapy, with or without a PD-L1 inhibitor.

The trial hit its primary endpoint of overall survival, with Tam-Peli producing a statistically significant and clinically meaningful benefit: it reduced the risk of death by 54%, with median overall survival reaching 13.3 months versus 9.4 months for topotecan (stratified hazard ratio 0.46, p<0.0001). The drug also performed strongly on secondary measures, extending median progression-free survival to 7.4 months compared with 2.8 months, and producing a substantially higher response rate, 59.1% versus 9.7% for the standard-of-care comparator.

The results are being presented as a late-breaking abstract during a Presidential Presentation at the IASLC 2026 World Conference on Lung Cancer in Seoul, with simultaneous publication in The New England Journal of Medicine. Separately, China’s National Medical Products Administration has accepted MediLink’s new drug application for filing.

Tam-Peli is a B7-H3-targeted antibody-drug conjugate built on MediLink’s proprietary TMALIN platform, which uses a dual release mechanism for its payload designed to boost antitumor activity while limiting off-target toxicity. Roche holds rights to develop and commercialize the drug outside mainland China, Hong Kong and Macau across multiple tumor types, and the company says it plans to move quickly into global trials. The drug already holds Breakthrough Therapy Designation from both the US FDA and China’s Center for Drug Evaluation for relapsed small-cell lung cancer.

Levi Garraway, Roche’s chief medical officer and head of global product development, said TAISHAN-302 is the second positive Phase III trial for Tam-Peli and reinforces the company’s confidence in its potential to improve outcomes for cancer patients. He said the survival and response rate improvements seen in this difficult-to-treat disease support Roche’s plans to launch global Phase III trials for the drug without delay.

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Related Topics and Keywords

Chinese small-cell lung cancer, Chinese small-cell lung cancer patients, MediLink, Phase III data, Roche, small-cell lung cancer, Tam-Peli