Roche's Tam-Peli Shows Significant Efficacy in SCLC Trial

Roche, a global healthcare company, announced significant advancements in its collaboration with MediLink, a biotech firm, with the release of phase III data for Tam-Peli, an antibody-drug conjugate targeting B7-H3. The trial, conducted in China, demonstrated Tam-Peli's efficacy in treating relapsed small-cell lung cancer (SCLC) patients who had progressed after prior platinum-based chemotherapy.

The phase III TAISHAN-302 trial, which enrolled 451 patients across 85 study sites in China, compared Tam-Peli with topotecan, a standard-of-care treatment. The results showed that Tam-Peli significantly reduced the risk of death by 54% and disease progression by 71%. Specifically, the median overall survival for patients receiving Tam-Peli was 13.3 months, compared to 9.4 months for those receiving topotecan. The objective response rate was 59.1% for Tam-Peli versus 9.7% for topotecan.

These findings are particularly significant given the aggressive nature of SCLC, which accounts for 15% of lung cancer diagnoses. Despite advances in first-line treatment, SCLC frequently relapses or progresses, leading to poor outcomes for many patients. The robust efficacy of Tam-Peli in this context underscores its potential to improve patient outcomes.

The trial also showed consistent improvements in progression-free survival and response rates across prespecified subgroups, including age, chemotherapy-free interval, and baseline liver or brain metastatic status. In patients with baseline brain metastases, Tam-Peli extended median intracranial progression-free survival to 6.1 months, compared to 4.2 months for topotecan. The intracranial response rate was 32.4% for Tam-Peli versus 2.9% for topotecan.

Safety data for Tam-Peli were also favorable, with lower rates of Grade 3 treatment-related adverse events (TRAEs) compared to topotecan. Serious TRAEs occurred in 25.9% of patients receiving Tam-Peli versus 36.4% with topotecan. Treatment-emergent interstitial lung disease (ILD/pneumonitis) was reported in 4.9% of Tam-Peli patients versus 1.4% with topotecan, with no Grade 4 or 5 events reported.

Tam-Peli is designed to target B7-H3, a protein highly expressed in solid tumours but minimally in healthy tissues. Built on MediLink's TMALIN® platform, its stable linker and dual-release mechanism are designed to maximize therapeutic efficacy while minimizing off-target toxicity. This unique approach is expected to offer a more targeted and effective treatment for SCLC patients.

Roche holds development, manufacturing, and commercialization rights for Tam-Peli worldwide, excluding mainland China, Hong Kong, and Macau. The company plans to rapidly initiate global phase III trials to further evaluate the drug's potential in treating SCLC and other solid tumours.

The positive results from the TAISHAN-302 trial, following the successful phase III TAISHAN-301 trial in nasopharyngeal carcinoma, reinforce Roche's commitment to advancing cancer treatments. With two positive phase III trials under its belt, Roche is well-positioned to bring Tam-Peli to market and potentially offer a new treatment option for patients with SCLC.