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Roche (SIX: RO) announced interim results from a Phase III trial of Tam-Peli, an investigational antibody-drug conjugate, showing significant survival improvements in patients with relapsed small-cell lung cancer. The company said the drug reduced the risk of death by 54% compared to topotecan, the standard-of-care treatment, in a Chinese patient population.

According to the filing, the randomized TAISHAN-302 trial met its primary endpoint of overall survival. Roche reported that patients receiving Tam-Peli achieved a median overall survival of 13.3 months versus 9.4 months for those on topotecan, with a hazard ratio of 0.46. The company also said Tam-Peli demonstrated a confirmed objective response rate of 59.1% compared to 9.7% for topotecan, and extended median progression-free survival to 7.4 months from 2.8 months.

The trial enrolled 225 patients receiving Tam-Peli and 226 receiving topotecan. According to the announcement, Roche said the drug showed consistent improvements across patient subgroups including those with different chemotherapy-free intervals and baseline brain metastases. In patients with baseline brain metastases, the company reported Tam-Peli extended median intracranial progression-free survival to 6.1 months from 4.2 months.

Roche said Tam-Peli demonstrated a favorable safety profile, with lower rates of Grade 3 or higher treatment-related adverse events at 46.4% compared to 74.7% for topotecan. The company reported serious treatment-related adverse events occurred in 25.9% of Tam-Peli patients versus 36.4% with topotecan. According to the filing, treatment-emergent interstitial lung disease occurred in 4.9% of Tam-Peli patients versus 1.4% with topotecan, with no Grade 4 or 5 events reported in either group.

Tam-Peli is a B7-H3-targeted antibody-drug conjugate developed through a collaboration between Roche and MediLink Therapeutics. The company said it holds development, manufacturing, and commercialization rights for Tam-Peli worldwide outside mainland China, Hong Kong, and Macau. According to the announcement, Roche plans to rapidly initiate global Phase III trials across multiple tumor types.

The trial results represent the second positive Phase III readout for Tam-Peli, following the TAISHAN-301 trial in nasopharyngeal carcinoma. Roche said Tam-Peli has received U.S. FDA and China CDE Breakthrough Therapy Designations for relapsed small-cell lung cancer. The company also announced that China’s Center of Drug Evaluation has accepted the New Drug Application for filing.

Separately, Roche announced that the U.S. FDA granted Priority Review to Enspryng for myelin oligodendrocyte glycoprotein antibody-associated disease, a rare autoimmune condition with no approved treatments. The company said the FDA is expected to make an approval decision by January 10, 2027.

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