The BioPharm Brief: Survival, Scrutiny, and a Setback

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here’s what we’re talking about today.

First, Amgen and AstraZeneca have a significant phase 3 win in small cell lung cancer. The DeLLphi-305 trial found that Imdelltra, or tarlatamab, plus Imfinzi significantly improved overall survival compared with Imfinzi alone as first-line maintenance therapy for extensive-stage small cell lung cancer. The combination also improved progression-free survival and objective response rate. It’s the first phase 3 study of a bispecific T-cell engager to demonstrate an overall survival benefit in this earlier-line setting, potentially expanding the role of DLL3-targeted therapy in small cell lung cancer.

Next, Rezolute has an unusual FDA review underway for ersodetug in congenital hyperinsulinism. The phase 3 sunRIZE trial missed both its primary and key secondary endpoints, but additional continuous glucose monitoring analyses showed reductions of 50% or more in some measures of hypoglycemia. The FDA requested source and analysis datasets after raising concerns about limitations of self-monitored blood glucose measurements and behavioral factors. The agency is now independently reviewing the additional data, but there is no set timeline for a decision.

And finally, Novartis’s del-desiran missed the primary endpoint in phase 3. The HARBOR trial did not show a significant improvement in video hand opening time in patients with myotonic dystrophy type 1, although the company reported signs of activity on secondary and exploratory measures. Novartis is evaluating the full dataset and will discuss the next steps with health authorities. The setback comes despite earlier phase 1/2 data showing reductions in toxic DMPK RNA and correction of disease-associated mis-splicing.

That’s The BioPharm Brief for today. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways:

• Imdelltra + Imfinzi: A phase 3 survival win in first-line small cell lung cancer.
• Rezolute’s ersodetug: FDA is reviewing additional data after the phase 3 trial missed its endpoints.
• Novartis’ del-desiran: Phase 3 missed its primary endpoint in myotonic dystrophy type 1.