A study indicates that a drug developed by Amgen (Amgen) when used in combination with AstraZeneca (AstraZeneca)'s immunotherapy may provide significantly longer survival times for patients with lung cancer, which is known to be aggressive.

The full results of a late-stage trial announced on Saturday showed that in patients with extensive-stage small cell lung cancer, adding Amgen's immunotherapy Imdelltra to AstraZeneca's Imfinzi reduced the risk of death by 58%. Extensive-stage small cell lung cancer is a disease that grows rapidly and has already spread beyond the initial site of onset in the lungs.

The trial showed that this combination of drugs extended the median overall survival of patients to 21.1 months, compared to 12.7 months when using AstraZeneca's drug alone.

This means that half of the patients who received the combined treatment survived for at least approximately 21 months. In this trial, this combination was used for maintenance therapy; the subjects had previously received initial treatment with Imfinzi and chemotherapy, and their cancer had not progressed yet.

In an interview, Paul Burton ( Paul Burton ) Ph.D., Chief Medical Officer of Amgen, said: "I believe that in the field of medicine, there are moments when you see a set of data so significant that it will change the standard treatment for patients. I truly believe that we are at that moment."

He said that this combination “has the potential to challenge one of the most aggressive cancers we face today, and almost turn it into a chronic disease,” and added, “These data indicate that this possibility does exist.”

These results also indicate that the business opportunities for Imdelltra may be even greater. The drug's sales in the second quarter amounted to 288 million US dollars, a year-on-year increase of 115%. By 2025, the global sales of this drug had reached 627 million US dollars, and it seems to be on its way to becoming a blockbuster drug, with the potential to reach a sales threshold of 1 billion US dollars.

Dr. Jacob Sands, the lead investigator of the trial and Deputy Director of the Lowe Thoracic Tumor Center at Dana-Farber Cancer Institute (Dana - Farber Cancer Institute), stated that small cell lung cancer remains difficult to treat because, although chemotherapy is initially effective for most patients, the disease often recurs or progresses within a few months.

He said that immunotherapy has helped a small portion of patients achieve several years of disease control, but most patients have not benefited in the same sustained manner, which highlights the necessity for better treatment options. There are approximately 31,000 new cases of small cell lung cancer in the United States each year, and it is estimated that 60% to 70% of these cases are diagnosed as advanced-stage disease.

Sands said that the benefits observed in the trial were evident in all patient subgroups, including those whose cancer had spread to the brain or liver. Diseases that have spread to these organs are usually associated with poorer treatment outcomes.

He added that as more long-term follow-up data on patients becomes available, the figure of 21 months "may change further, and it is hoped that there will be a significant improvement," which is similar to what Amgen observed in a Phase I trial of this immunotherapy combination. In that earlier trial with a smaller sample size, long-term follow-up showed that the benefits could last for several years.

Used Imdelltra earlier.

Janssen indicated that these findings also suggest that the use of Imdelltra at an earlier stage of patient treatment could potentially alter the course of the disease substantially. Imdelltra is currently approved for patients with small cell lung cancer who experience progression during or after platinum-based chemotherapy.

What the researchers specifically tested was whether adding Imdelltra to the already approved treatment regimen of Imfinzi as a first-line therapy for this type of lung cancer could help patients live longer than those who continued to use only Imfinzi. Amgen stated that among patients who began using both drugs simultaneously, nearly 80% were still alive after one year, while for those who used only Imfinzi, this proportion was 53%.

Sands said that the “huge impact” of Imdelltra in controlling diseases and ultimately extending survival highlights the importance of including it in ongoing maintenance therapy. This refers to the treatment continued after initial intensive treatments such as chemotherapy or surgery.

Burton added that this makes Amgen's drug an "indispensable cornerstone treatment" for small cell lung cancer, regardless of which other immunotherapies it can be used in combination with.

Imdelltra functions by binding to the DLL3 protein on cancer cells and the CD3 protein on T cells. T cells are a type of immune cell that can kill cancer cells. By binding to both simultaneously, Imdelltra draws T cells closer to tumor cells, helping the immune system to destroy cancer.

Imfinzi produced by AstraZeneca is a form of immunotherapy that blocks a protein called PD-L1, which cancer cells utilize to evade the immune system. The two drugs work together in a complementary manner: Imfinzi helps to release the “brakes” on the immune response, while Imdelltra directs T cells directly to the cancer cells and helps to activate their attack on the tumor.

This research was presented at the European Society of Medical Oncology Congress ( European Society for Medical Oncology Congress ), a major cancer conference, but it did not test whether this combination is superior to other first-line treatment options.

Nevertheless, these results indicate that Amgen's drug may become another option for patients with small cell lung cancer at earlier stages of treatment. Kate Brennan ( Kate Brenan ), a 44-year-old mother of two from Denver, believes that this is a good thing in and of itself.

In early January 2024, she was diagnosed with extensive-stage small cell lung cancer. Brennan underwent six rounds of common combination chemotherapy, followed by chest radiotherapy, and later received whole-brain radiotherapy after the cancer had spread.

In September 2024, she began using Imdelltra, and since then, no evidence of disease has been found.

“I think it’s truly amazing how rapidly the options for treating small cell cancer are changing,” Brennan told CNBC, and added that if Imdelltra becomes a treatment option sooner, “that would only be good for future patients, and I’m really very excited about that.”