Phase 2 trial of DS-1062a in pretreated advanced NSCLC with genomic alterations posts no results

This was a Phase 2 interventional clinical trial investigating the antibody-drug conjugate DS-1062a. The study enrolled 137 participants with advanced or metastatic non-small cell lung cancer (NSCLC) harboring actionable genomic alterations. All participants had been previously treated with at least 1 platinum-containing therapy and 1 or more lines of targeted therapy. The intervention was DS-1062a administered at a dose of 6.0 mg/kg. The primary outcome was the percentage of participants achieving an objective response rate (ORR) as assessed by blinded independent central review (BICR). No comparator arm was reported. No efficacy results, including the primary ORR endpoint, were provided in the input data. Similarly, no safety or tolerability data—such as rates of adverse events, serious adverse events, or treatment discontinuations—were reported. The study's follow-up duration and specific secondary outcomes were also not detailed. Key limitations include the absence of reported results, which precludes any assessment of efficacy or safety. The trial setting and specific actionable alterations within the population were not described. The study was sponsored by Daiichi Sankyo, the developer of DS-1062a. Given the complete lack of reported outcomes, no conclusions can be drawn regarding the drug's activity, safety profile, or potential role in this pretreated patient population. Clinical interpretation must await the publication of peer-reviewed results.