Misty Shields, Assistant Professor at Indiana University School of Medicine, Indiana University Health, shared on LinkedIn:
“Today, Amgen issued the press release for DeLLphi-305, the Phase 3 study of tarlatamab in the 1L maintenance setting with durvalumab, compared to durvalumab alone for extensive-stage SCLC.
The study met its primary endpoint at a pre-specified interim analysis demonstrating improvements in OS, along with PFS and ORR, with the addition of a DLL3xCD3 bispecific T-cell engager (TCE) to 1L maintenance.
While this represents an unprecedented outcome for our Small Cell SMASHERS impacted by ES-SCLC, and one step closer to changing the history of SCLC, several questions remain to be addressed:
1. Access
Progress only matters IF we can get therapies to those who need it. What about our SMASHERS all over the world who have not yet had access to tarlatamab for 2L and beyond? How long will 1LM take to implement? How can we work together to provide equitable access to all?
Tarlatamab was approved in the US for accelerated use on May 16, 2024, yet our patients globally still cannot access it in most countries outside of a trial.
2. Support
With novel therapeutics such as TCEs in SCLC, maximized support to proactively recognize side effects will be key to ensure patients are living WELL for years on treatment.
CRS, ICANS, and dysgeusia require aggressive multiD support to mitigate and manage.
3. Personalization of care
Biomarker discovery for tarlatamab, beyond DLL3, is needed. We must identify WHO will benefit from intensification of 1L maintenance, vs can avoid potential time, treatment, and financial toxicities.”
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