Retsevmo

Retsevmo is indicated as monotherapy for adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. It is also indicated as monotherapy for adults with advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib. The application for Retsevmo was submitted on 20 December 2019, and a CHMP positive opinion was issued on 10 December 2020.

In efficacy trials, Retsevmo demonstrated an Objective Response Rate (ORR) of 63.8%. The Median Duration of Response (DoR) was 17.5 months. For patients with RET-fusion positive thyroid cancer (19 patients), the Objective Response Rate (ORR) was 78.9%, with a Median Duration of Response (DoR) of 18.43 months and a Median Overall Survival (OS) of 27.20 months. In the IAS population, the Objective Response Rate (ORR) was 56.5%, and the Median Progression-Free Survival (PFS) was 19.32 months.

Regarding safety, 99.2% of patients experienced at least one treatment-emergent adverse event (TEAE) of any grade, with 92.5% of TEAEs attributed to selpercatinib. Grade 3 or higher TEAEs occurred in 59.7% of patients, and 32.0% of these were related to selpercatinib. Specific Grade 3-4 adverse events included hypertension (19.2%), ALT increase (9.8%), and AST increase (8.3%). Deaths occurred in 13.9% of the safety population, with 67.3% due to disease progression and 24% due to adverse events.