In a field where extensive-stage small-cell lung cancer has long offered few durable answers, a new trial suggests that the arc of treatment may bend slightly further than before. Amgen's DeLLphi-305, presented at the European Society for Medical Oncology Congress in 2026, found that adding its DLL3-targeting drug IMDELLTRA to AstraZeneca's IMFINZI as maintenance therapy reduced the risk of death by 58% compared with IMFINZI alone. The findings, published alongside their presentation, mark a hopeful step for patients who have too often faced this disease with narrowing options, and they invite
Amgen's IMDELLTRA Cuts Risk of Death 58% in Extensive-Stage Small-Cell Lung Cancer Phase III Trial
Risk of death cut 58% when IMDELLTRA joined maintenance therapy
Mark
Start with the headline number. What does a 0.42 hazard ratio actually say?
Mimi
That patients on the combination had a 58% lower risk of death than those on IMFINZI alone, at the point of analysis. The P value was below 0.001, so the result was statistically significant.
Mark
The progression-free numbers look dramatic too.
Mimi
Median progression-free survival went from 1.9 months to 7.4. Response rate rose from 4% to 26%. And 44% of patients on the combination were still on treatment at cutoff, versus 11% of controls.
Luke
Worth noting that the 58% is a relative figure. The source gives no median overall survival in months, so we can't say how much longer people lived.
Mark
Does it hold up for harder-to-treat patients?
Mimi
Rudin said the benefit extended to all analyzed subgroups, including brain and liver metastases. About 20% had brain metastases and roughly a third had liver metastases.
Luke
That's Rudin's characterization of the data. The source doesn't give subgroup hazard ratios, so I can't judge how consistent those results were.
Mark
And safety?
Mimi
One Grade 3 cytokine release syndrome event, no Grade 3 or higher neurotoxicity, and no fatal treatment-related events. Discontinuations or holds were 3% for each drug.
Luke
Adverse events did increase, and Rudin called them manageable. Regulators haven't reviewed this yet, and Amgen has only said it plans to submit.
Der Puls
- A trial in extensive-stage small-cell lung cancer shows the combination cut the risk of death by 58 percent, a result that has drawn immediate attention across oncology.
- Median progression-free survival climbed from 1.9 months to 7.4 months, and the response rate rose from 4 percent to 26 percent, signaling a sharp shift in how patients are doing.
- Known toxicities from this class of BiTE therapies were watched closely, yet no fatal treatment-related events were recorded and only a single Grade 3 cytokine release syndrome case appeared.
- Amgen is moving quickly toward global regulatory submissions while testing the drug in first-line and limited-stage settings, with the trajectory pointing toward earlier use in treatment.
In a field where extensive-stage small-cell lung cancer has long offered few durable answers, a new trial suggests that the arc of treatment may bend slightly further than before. Amgen's DeLLphi-305, presented at the European Society for Medical Oncology Congress in 2026, found that adding its DLL3-targeting drug IMDELLTRA to AstraZeneca's IMFINZI as maintenance therapy reduced the risk of death by 58% compared with IMFINZI alone. The findings, published alongside their presentation, mark a hopeful step for patients who have too often faced this disease with narrowing options, and they invite the oncology community to consider where such a benefit might reach next.
At the European Society for Medical Oncology Congress 2026, Amgen presented the results of DeLLphi-305, a Phase III trial in extensive-stage small-cell lung cancer. Adding IMDELLTRA, a BiTE therapy that targets DLL3, to AstraZeneca's IMFINZI as maintenance treatment cut the risk of death by 58 percent compared with IMFINZI alone. The overall-survival hazard ratio was 0.42, and the results were published at the same time in The New England Journal of Medicine.
The benefit was not limited to survival numbers. Median progression-free survival rose from 1.9 months to 7.4 months, and the response rate climbed from 4 percent to 26 percent. Charles Rudin of Memorial Sloan Kettering, who presented the data, noted that more than half of responders in the combination group were still responding a year later. The benefit held across subgroups, including patients with brain or liver metastases, and Rudin called the findings practice-changing.
Safety was described as manageable. Treatment-related events led to discontinuation or holds in 3 percent of patients for each drug, and no treatment-related deaths were reported. Amgen executives said the maintenance setting was chosen because induction chemoimmunotherapy had already shrunk tumors, and they pointed to shorter monitoring windows as a possible aid to wider access.
Amgen plans rapid global regulatory submissions and is studying the drug in first-line settings, limited-stage disease, and combinations with other therapies. The company also intends to explore neuroendocrine cancers and other DLL3-expressing tumors.
At the European Society for Medical Oncology Congress 2026, Amgen presented results from DeLLphi-305, a Phase III trial in extensive-stage small-cell lung cancer. Adding its drug IMDELLTRA to AstraZeneca's IMFINZI (durvalumab) as maintenance treatment cut the risk of death by 58% compared with IMFINZI alone. The overall-survival hazard ratio was 0.42, with a P value below 0.001, according to the presentation.
IMDELLTRA is a BiTE therapy that targets DLL3. The trial tested it in the first-line maintenance setting. Patients were randomly assigned after finishing four cycles of induction chemotherapy plus immunotherapy, and each had stable disease or better when enrolled. The primary endpoint was overall survival. The results were shown at an ESMO presidential symposium and published at the same time in The New England Journal of Medicine, according to Charles Rudin of Memorial Sloan Kettering Cancer Center, who presented them.
Progression-free survival also improved. Median progression-free survival was 7.4 months on the combination and 1.9 months on IMFINZI alone. The progression-free survival hazard ratio was 0.34, a 66% reduction in the risk of progression or death, again with a P value below 0.001. The overall response rate was 26% for the combination and 4% for IMFINZI alone. Rudin said more than half of the responders in the combination group were still responding a year later. At data cutoff, 44% of patients on the combination remained on treatment, against 11% in the control group.
The trial included patients with treated or untreated asymptomatic brain metastases. About 20% of enrolled patients had brain metastases and roughly a third had liver metastases, and baseline characteristics were described as balanced between the arms. Rudin said, "The survival benefit really extends to all subgroups analyzed, including those patients with brain metastases, liver metastases, and irrespective of the chemotherapy combination used in induction." He called the results "practice-changing data."
On safety, Rudin said adverse events rose with the second drug but were manageable. Treatment-related events led to discontinuation or treatment holds in 3% of patients for each of the two medicines in the combination arm. No fatal events were attributed to treatment. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome are the two main toxicities associated with BiTE therapies. DeLLphi-305 recorded one Grade 3 cytokine release syndrome event in the combination arm and no Grade 3 or higher neurotoxicity events.
Jean-Charles Soria, Amgen's senior vice president of oncology global development, said the maintenance setting was chosen partly because induction chemoimmunotherapy had already reduced patients' tumors, which the company expected to support both efficacy and tolerability. Kaveh Niksefat, the company's senior vice president of global marketing and access, said median treatment duration in DeLLphi-305 was 46 weeks, compared with 18 weeks in the second-line DeLLphi-304 trial. He also pointed to monitoring of one to two hours in DeLLphi-305 as a possible aid to wider access if the drug moves earlier in treatment.
IMDELLTRA is already approved in more than 15 markets for second-line or later extensive-stage disease, Amgen said, and more than 18,000 patients have been treated since launch. In the U.S. it is available at more than 2,000 sites of care, and over 65% of sites that have used it are community settings.
Amgen plans to submit the DeLLphi-305 data to regulators globally on a rapid timeline. It is also studying the drug in first-line induction and maintenance in the Phase III DeLLphi-312 trial, and after concurrent chemoradiotherapy for limited-stage disease in DeLLphi-306. Other work covers alternative dosing schedules, subcutaneous administration and combinations with antibody-drug conjugates. Soria said the company also plans to evaluate it in neuroendocrine cancers and other DLL3-expressing malignancies.
Bemerkenswerte Zitate
The survival benefit really extends to all subgroups analyzed, including those patients with brain metastases, liver metastases, and irrespective of the chemotherapy combination used in induction.— Charles Rudin, Memorial Sloan Kettering Cancer Center
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