Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its co-development partner Daiichi Sankyo (TYO: 4568), have announced preliminary data from a Phase II clinical trial for the investigational B7-H3-directed antibody-drug conjugate (ADC) ifinatamab deruxtecan. The trial has identified a recommended dosage of 12mg/kg for the second phase of the study, based on an interim analysis from the Ideate-Lung01 Phase II study, a global, multicenter, randomized, open-label two-part trial designed to assess the ADC’s efficacy in treating extensive stage small-cell lung cancer (ES-SCLC).
The first stage of the trial, focusing on dose optimization, has been completed. It involved patients who had received at least one prior line of platinum-based chemotherapy and up to three prior lines of therapy. Patients were administered ifinatamab deruxtecan at either 8mg/kg or 12mg/kg dosages. The 12mg/kg cohort recorded 23 partial responses (PR), compared to 1 complete response (CR) and 11 PRs in the 8mg/kg cohort. The median duration of response (DoR) was 4.2 months for the 8mg/kg group and 7.9 months for the 12mg/kg group. The disease control rate (DCR) was 90.5% and 80.4% for the 12mg/kg and 8mg/kg cohorts, respectively. Survival data showed a median progression-free survival (PFS) of 5.5 months for the 12mg/kg group and 4.2 months for the 8mg/kg group, while median overall survival (OS) was 11.8 months and 9.4 months, respectively.
The second extension phase of the trial will administer the 12mg/kg recommended dose to patients who have been previously treated with at least two lines of systemic therapy. Additionally, the Phase III Ideate-Lung02 trial has commenced, comparing the ADC to chemotherapy in treating ES-SCLC.
Merck considers the objective response rate (ORR) and particularly the overall survival (OS) benefit of nearly 12 months as a significant validation of the potential role of ifinatamab deruxtecan in the treatment of small-cell lung cancer (SCLC).- Flcube.com
