Merck/Daiichi Sankyo Partnered Lung Cancer Candidate Meets Primary Goal In Late-Stage Study

Tuesday, Merck & Co Inc MRK released topline data from the HERTHENA-Lung02 phase 3 trial of patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment.

The study met its primary endpoint of progression-free survival (PFS), with patritumab deruxtecan demonstrating a statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy.

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Overall survival (OS) data were immature at the time of the analysis, and the trial will continue to assess OS, a secondary endpoint.

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo Ltd DSNKY and being jointly developed by Daiichi Sankyo and Merck.

The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials, with no new safety signals identified.

The majority of interstitial lung disease (ILD) events were low-grade (grades 1 and 2). Two grade 5 ILD events were observed.

Recently, Summit Therapeutics Inc. SMMT released data from the primary analysis of the Phase 3 HARMONi-2 trial of ivonescimab conducted in China, sponsored by collaboration partner Akeso, Inc.

The trial evaluated monotherapy ivonescimab against Merck’s Keytruda (pembrolizumab) in patients with locally advanced or metastatic non-small cell lung cancer whose tumors have positive PD-L1 expression.

Ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival, compared to monotherapy pembrolizumab, achieving a hazard ratio of 0.51.

Price Action: MRK stock is up 0.39% at $118.42 during the premarket session at last check Tuesday.

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