The Phase III DeLLphi-305 trial has delivered encouraging results in extensive-stage small cell lung cancer, with tarlatamab plus durvalumab significantly improving overall survival. Here’s what leading oncology experts had to say about the results and what they could mean for patients.
Mohit Manrao, SVP, Head of US Oncology at AstraZeneca:
“This post is intended for a U.S. audience.
Encouraging news for patients living with extensive-stage small cell lung cancer.
Today, AstraZeneca and our partner Amgen announced positive high-level Phase III results from the DeLLphi-305 trial in extensive-stage small cell lung cancer. The study demonstrated a statistically significant and clinically meaningful improvement in overall survival at a planned interim analysis.
Small cell lung cancer remains one of the most aggressive forms of lung cancer, with limited treatment advances and poor long-term outcomes for many patients. Despite progress in recent years, far too many patients see their disease progress quickly, and some never have the opportunity to receive subsequent treatment.
These results are especially meaningful because they suggest a potential new approach to extending survival earlier in the treatment journey and represent an important step forward for the small cell lung cancer community.
We look forward to sharing the full results with the scientific community at an upcoming medical meeting. Read more in the press release.”
Rajat Thawani, Assistant Professor at the Knight Cancer Institute at OHSU:
“Amgen announced that DeLLphi-305 (NCT06211036) met its primary endpoint at a prespecified interim analysis. Tarlatamab plus durvalumab as first-line maintenance improved overall survival versus durvalumab alone in extensive-stage SCLC.
Still, about 40% of these patients never reach second-line. The whole argument is that we should move what works earlier, and it looks like it landed. Now hopefully, the hazard ratio is low enough to move maintenance without second thoughts.”
Misty Shields, Assistant Professor at Indiana University School of Medicine, Indiana University Health:
“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:
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.
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.
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.”
Estela Rodriguez, Associate Director of Community Outreach-Thoracic Oncology at Sylvester Comprehensive Cancer Center:
“Big news in Small Cell Lung Cancer!
DeLLphi 305, a Phase 3 study of tarlatamab maintenance with chemo-IO + durvalumab in SCLC, met its primary endpoint. Bringing tarlatamab to the frontline could improve survival in a disease long marked by therapeutic nihilism.
How to improve access and ease of administration ( check out WCLC26 abstract ) how to improve patient selection and minimize toxicity.”
“SCLC news: Amgen announced that a Phase 3 study evaluating its DLL3-targeting therapy as part of first-line maintenance treatment for patients with extensive-stage small cell lung cancer met its primary endpoint.
Giannis Mountzios, Director of 4th Oncology Department and Clinical Trials Unit at Henry Dunant Hospital Center:
“Time to move T-cell engagers to 1st-L maintenance? A new era is dawning for our patients with SCLC.
The much-awaited press-release from DeLLphi-305 confirms that analysis has demonstrated a statistically significant and clinically meaningful improvement in overall survival with tarlatamab in combination with durvalumab compared to durvalumab alone. Full data coming soon!”
Noemi Reguart, Medical Oncologist at Hospital Clinic Barcelona:
“A great day for our patients and the entire SCLC community! Thrilled to see the positive results from DeLLphi-305. A landmark achievement in SCLC!”
Antonio Calles, Medical Oncologist at Hospital General Universitario Gregorio Marañón and faculty member of the Lung and Other Thoracic Tumours faculty group of the ESMO:
“Just received this. The golden era in SCLC! The DeLLphi-305 (Phase 3 Study in First-Line ES-SCLC Following Platinum, Etoposide and Durvalumab) OS Interim Analysis has been conducted.
The analysis has demonstrated a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA® (tarlatamab-dlle) in combination with AstraZeneca’s Imfinzi® (durvalumab) compared to durvalumab alone.”
Gilberto Lopes, Chief of the Division of Medical Oncology at Sylvester Comprehensive Cancer Center:
“Big news in SCLC today. Phase III DeLLphi-305: tarlatamab + durvalumab maintenance improved OS vs durvalumab alone after first-line platinum/etoposide + durvalumab in ES-SCLC. PFS and ORR also positive. Very encouraging-full data will matter.
We still need the numbers: HR, median OS, subgroups and detailed safety. If the magnitude holds up, this could meaningfully change first-line ES-SCLC treatment.
Visual summary of today’s phase 3 DeLLphi-305 update in ES-SCLC: tarlatamab + durvalumab maintenance improved OS vs durvalumab alone after induction durvalumab + platinum/etoposide. PFS and ORR also positive. Full data still needed.”
