Merck & Co. (MRK.US) and Daiichi Sankyo Inc. announced interim data of a new lung cancer drug, I-DXd

Intellidex learned that Merck (MRK.US) and Daiichi Sankyo on Saturday announced the interim results of a Phase 2 trial of the drug ifinatamab deruxtecan (I-DXd) in patients with lung cancer, a new class of cancer drugs called antibody-drug conjugates (ADCs).

The companies said that the 12mg/kg dose and 8mg/kg dose of I-DXd showed activity in small cell lung cancer, with confirmed objective response rates (ORR) of ~55% and ~26%, respectively. The detailed results of the IDeate-Lung01 trial showed that the 12mg/kg dose was associated with 23 partial responses (PRs), while the 8mg/kg dose was associated with 1 complete response (CR) and 11 PRs. The median follow-up times were 15.3 months and 14.6 months for the double dose groups, respectively, and the median overall survival was 11.8 months and 9.4 months for the 12mg/kg and 8mg/kg dose groups, respectively.

The companies also announced preliminary response data in patients with brain metastases and noted that the intracranial ORR was 50.0% and 66.7% for the two dose groups, respectively. In terms of safety, 17% of patients in the 12mg/kg group withdrew from the trial due to adverse events, and 6.5% of patients in the 8mg/kg group withdrew. Merck and Daiichi Sankyo chose the 12mg/kg dose for the dose-escalation part of the trial.

The global study, which is composed of two parts, enrolled patients with extensive-stage small cell lung cancer who had received a median of two prior regimens, with over 75% of patients having received immunotherapy.