The Amgen logo is displayed outside the Amgen headquarters in Thousand Oaks, California on May 17, 2023.
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A medicine of Amgen could give patients with a notoriously aggressive form of lung cancer much more time to live when added to immunotherapy AstraZenecaaccording to a study.
Full results from a late-stage trial released Saturday show that adding Amgen’s immunotherapy Imdelltra to AstraZeneca’s Imfinzi drug reduced the risk of death by 58% in patients with advanced small-cell lung cancer, a fast-growing disease that has spread beyond the lung where it started.
The drug combination extended their median overall survival to 21.1 months, compared to 12.7 months with AstraZeneca’s drug alone, the trial found.
This means that half of the patients in the combined diet group had been alive for at least about 21 months. The trial tested the combination as maintenance treatment in patients who received initial treatment with Imfinzi and chemotherapy and whose cancer had not progressed.
“I think there are moments in medicine where you see data so profound that it’s going to transform the standard of care for patients, and I think, honestly, we’re at that moment,” Dr. Paul Burton, Amgen’s chief medical officer, said in an interview.
This combination “has the potential to take on one of the most aggressive cancers we face today and turn it almost into a chronic disease,” he said, adding that “this data indicates that is a possibility.”
The results also suggest a greater business opportunity for Imdelltra, which reported second-quarter revenue of $288 million, up 115% year-over-year. The drug has already generated $627 million in global sales in 2025 and appears to be on track to becoming a blockbuster drug, or reaching the billion-dollar sales threshold.
Small cell lung cancer remains difficult to treat because, although chemotherapy initially works well for most patients, the disease often returns or progresses within a few months, said Dr. Jacob Sands, principal investigator of the trial and associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.
He said immunotherapy helped a small subset of patients achieve years of disease control, but most did not experience such lasting benefits, highlighting the need for better treatments. There are approximately 31,000 new cases of small cell lung cancer in the United States each year, and an estimated 60 to 70 percent of these people are diagnosed with advanced disease.
Sands said the trial’s benefits were seen in subgroups of patients, including those whose cancer has spread to the brain or liver. Diseases that have spread to these organs are associated with poorer treatment outcomes.
He added that with longer-term follow-up data on patients, the 21-month figure “could evolve further and hopefully improve significantly,” similar to what Amgen saw in a Phase 1 trial of the immunotherapy combination. In this preliminary trial conducted on a smaller number of patients, long-term follow-up showed that the benefit was maintained for years.
Use Imdelltra sooner
Amgen said the results also suggest that using Imdelltra earlier in a patient’s treatment could significantly change the trajectory of the disease. Imdelltra is currently approved for patients whose small cell lung cancer has progressed during or after platinum-based chemotherapy.
The researchers specifically tested whether adding Imdelltra could help patients live longer than continuing Imfinzi alone, which is already approved as the first treatment for this type of lung cancer. Amgen said nearly 80% of patients who started taking both drugs were alive after a year, compared with 53% receiving Imfinzi alone.
Imdelltra’s “great impact” on disease control and ultimately how long people live highlights the importance of including it in first-line maintenance therapy, Sands said. This refers to continued treatment given after a first heavy treatment, such as chemotherapy or surgery.
Burton added that he positions Amgen’s drug as a “must-have core therapy” for small cell lung cancer, regardless of other immunotherapy that may be combined with it.
Imdelltra binds to DLL3, a protein found on cancer cells, and CD3, a protein found on T cells, which are a type of immune cell that can kill cancer. By binding to both, Imdelltra puts T cells in close contact with tumor cells, helping the immune system destroy the cancer.
Imfinzi, made by AstraZeneca, is an immunotherapy that blocks a protein called PD-L1, which cancer cells use to evade the immune system. The drugs work together in a complementary way: Imfinzi helps remove barriers to the immune response, while Imdelltra brings T cells directly to cancer cells and helps activate them to attack the tumor.
The study, which was presented at a major cancer meeting called the Congress of the European Society of Medical Oncology, did not test whether the combination was better than other first-line treatment approaches.
Still, the results suggest that Amgen’s drug could be another option for small cell lung cancer patients earlier in their treatment. Kate Brenan, a 44-year-old mother of two from Denver, considers that a victory in itself.
He was diagnosed with extensive stage small cell lung cancer in early January 2024. Brenan underwent six cycles of a common combination chemotherapy, followed by chest radiation and later whole brain radiation after the cancer spread.
In September 2024, she started Imdelltra and has had no signs of illness since then.
“I think it’s remarkable how quickly things are changing in the world of small cancer treatment options,” Brenan told CNBC, adding that Imdelltra becoming an earlier treatment option “can only be a good thing for patients moving forward, and I’m really excited about that.”
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