Amgen's Imdelltra scores again in small cell lung cancer
Amgen's fast-growing cancer immunotherapy Imdelltra could move into the first-line setting in small cell lung cancer (SCLC), after delivering as a dual regimen with AstraZeneca's Imfinzi in the DeLLphi-305 study.
The trial compared the combination as a first-line maintenance therapy to Imfinzi (durvalumab) alone in patients with extensive-stage SCLC (ES-SCLC) whose disease had not progressed after standard induction therapy.
Adding Imdelltra (tarlatamab) to Imfinzi in this setting led to statistically significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to Imfinzi, which has been approved by the FDA as a first-line treatment for ES-SCLC since 2020. The safety profile of the duo was consistent with what is known about the two individual medicines.
"Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment," said Jacob Sands, a thoracic oncology specialist at Dana-Farber Cancer Institute in the US.
"These patients do not have time to wait, making substantial progress in the first-line setting critically important," he added. "In my career treating people with extensive-stage small cell lung cancer, these are among the most compelling survival results I have seen."
Imdelltra has become a key growth product for Amgen since being approved as a treatment for ES-SCLC patients with disease progression on or after platinum-based chemotherapy, with sales reaching $627 million in 2025, its first full year on the market.
The drug has assumed even more importance for Amgen, meanwhile, as the company battles to keep its rare disease therapy Tavneos (avacopan) on the market as regulators insist its benefits no longer outweigh its risks.
"Imdelltra has already revolutionised the standard of survival for patients with extensive-stage small cell lung cancer whose disease progressed on or after prior treatment," commented Jay Bradner, Amgen's R&D head.
"These landmark results from DeLLphi-305 suggest Imdelltra will further revolutionise the standard for survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease," he added.
For AZ, meanwhile, it offers the prospect of extending the label for Imfinzi from its current use in combination with chemotherapy as a first-line therapy for ES-SCLC and as a maintenance therapy for limited-stage SCLC (LS-SCLC) in patients whose disease has not progressed following concurrent platinum-based chemo and radiation therapy (cCRT).
