More front-line Imdelltra details emerge

After Amgen earlier disclosed plans to broaden its push with Imdelltra into first-line small-cell lung cancer, more details on the planned Dellphi-312 trial have emerged via a new listing on clinicaltrials.gov. Dellphi-312 will test the DLL3-targeting T-cell engager as part of both induction (alongside Imfinzi and chemo) and maintenance (alongside Imfinzi) therapy in extensive-stage disease. This adds to an earlier first-line pivotal study, Dellphi-305, evaluating Imdelltra maintenance following induction with Imfinzi and chemo. The primary endpoint of both studies is overall survival. Amgen is also recruiting into Dellphi-306, in limited-stage SCLC, a potentially curative setting. At the recent ASCO meeting, Amgen’s vice-president of oncology global development, I-Fen Chang, told ApexOnco that giving Imdelltra earlier in the disease course, to fitter patients, could cut rates of cytokine release syndrome, a known side effect of the drug. This will need to be proven, but in the meantime Imdelltra looks on its way to full FDA approval in second-line SCLC, following a convincing overall survival benefit versus chemo in the confirmatory Dellphi-304 trial, presented at ASCO. The results were dubbed as “immediately practice changing” by the discussant, Massachusetts General Hospital's Dr Catherine Meador.

Pivotal trials of Imdelltra

Note: AA=accelerated approval; ES=extensive stage; LS=limited stage. Source: OncologyPipeline & clinicaltrials.gov.