Merck and Daiichi Sankyo Announce Interim Phase 2 Data of I-DXd in Extensive-Stage Small Cell Lung Cancer

Intelligent Finance News learned that Merck & Co., Inc. (MRK.US) and Daiichi Sankyo Company Limited released the interim results of a Phase 2 trial for the drug ifinatamab deruxtecan (I-DXd) in treating lung cancer patients on Saturday. The drug belongs to a new class of cancer therapeutics known as antibody-drug conjugates (ADCs).

The two companies stated that I-DXd at doses of 12 mg/kg and 8 mg/kg showed efficacy in small cell lung cancer, with confirmed objective response rates (ORR) of approximately 55% and 26%, respectively. Detailed results from the IDeate-Lung01 trial indicated that the 12 mg/kg dose was associated with 23 partial responses, while the 8 mg/kg dose was linked to 1 complete response and 11 partial responses. The median follow-up durations for the dual dosing groups were 15.3 months and 14.6 months, respectively, with median overall survival reaching 11.8 months for the 12 mg/kg group and 9.4 months for the 8 mg/kg group.

The two companies also announced preliminary remission data for patients with brain lesions, noting that the intracranial ORR reached 50.0% and 66.7% in the two dose groups, respectively. In terms of safety, 17% of patients in the 12mg/kg group discontinued the trial due to adverse events, while 6.5% of patients in the 8mg/kg group discontinued. Merck Sharp & Dohme AG and Daiichi Sankyo Company Limited selected the 12mg/kg dose for the dose expansion portion of the trial.

This global study, consisting of two parts, enrolled patients with extensive-stage small cell lung cancer who had previously received a median of two prior treatment regimens, with more than 75% of the patients having undergone immunotherapy.