Roche's MediLink ADC Falls Short of GSK in SCLC Trial

MediLink's Roche-partnered antibody-drug conjugate (ADC) has hit its primary endpoint in a phase 3 trial for small cell lung cancer (SCLC). The drug, tambotatug pelitecan (tam-peli), significantly improved median overall survival compared to the standard-of-care chemotherapy drug topotecan. However, it fell short of rival GSK's B7-H3 ADC, which achieved a median OS of 18.5 months in a phase 3 trial of Chinese patients with relapsed SCLC.

The median OS on tam-peli was 13.3 months, while topotecan achieved a median OS of 9.4 months. The rate of grade 3 adverse events, including interstitial lung disease (ILD), was lower for tam-peli compared to the competition. MediLink reported that only 0.9% of patients on tam-peli had grade 3 adverse ILD events, compared to 3.9% and 4.4% for GSK's and Merck-Daiichi's ADCs, respectively.

Roche plans to start a global phase 3 program 'quickly' based on the results, with the goal of differentiating its drug candidate from the competition. The search for an edge will extend to safety and tolerability data, where ILD remains a concern.