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Imdelltra is associated with improvement in overall survival compared to local standard-of-care chemotherapy among patients with small cell lung cancer.
Previous data found that the most common side effects were cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.
Imdelltra (tarlatamab-dlle) has shown statistically significant and clinically meaningful improvement in overall survival compared to local standard-of-care chemotherapy among patients with small cell lung cancer (SCLC) whose disease has progressed on or after a single line of platinum-based chemotherapy, it has been announced.
Amgen announced the development that Imdelltra had met its primary endpoint at a planned interim analysis of the global phase 3 DeLLphi-304 clinical trial in a news release.
“Small cell lung cancer is one of the most aggressive malignancies, with a high unmet need for more effective therapies,” said Dr. Jay Bradner, executive vice president, Research and Development, at Amgen. “The topline results from DeLLphi-304 demonstrate overwhelming clinical benefit for people living with this devastating disease and affirm Imdelltra as standard of care.”
A type of immunotherapy drug known as a bispecific T-cell engager, or BiTE, Imdelltra works by bringing healthy T cells, part of the body’s immune system, and lung cancer cells closer together so that the T cells can more effectively kill the lung cancer cells, as the National Cancer Institute explained on its website. It does so by binding to the protein CD3 on healthy T cells and the protein DLL3 on small cell lung cancer cells.
“It essentially forces an interaction between the tumor and the T cells that are otherwise repelling or ignoring one another,” says Dr. Carl Gay of the Department of Thoracic/Head and Neck Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston previously explained to CURE. “In doing so, the T cells finally gain access to the tumor, and seemingly recognize they’ve been sleeping on the job, and go about their expected role of attacking the tumor and eliminating at least a portion, if not, in some cases, nearly all of the tumor in some of the patients that have received this therapy.”
Overall survival: the time a patient lives, regardless of disease status.
Extensive-stage small cell lung cancer: cancer that has spread throughout the lung to the other lung, or to other parts of the body.
Cytokine release syndrome: a side effect involving symptoms such as fever, nausea, rash, headache, low blood pressure, rapid heartbeat and difficulty breathing after the rapid release of proteins known as cytokines into the blood
Pyrexia: fever.
Dysgeusia: altered taste.
Imdelltra received accelerated approval from the U.S. Food and Drug Administration in May 2024 for patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy was based on phase 2 results from the DeLLphi-301 clinical trial.
The FDA reported at the time that the most common side effects, experienced by more than 20% of patients, were cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.
The safety profile of Imdelltra, Amgen noted in the recent press release, was consistent with the drug’s known safety profile. Detailed data from DeLLphi-304, the company stated, will be presented at an upcoming medical congress.
With 509 patients enrolled, the currently active DeLLphi-304 clinical trial is being held at 223 locations around the world, according to its listing on clinicaltrials.gov. The trial, according to the listing, is estimated to be completed on July 31, 2027.
Small cell lung cancer, Amgen detailed in the news release, has a 5% to 10% five-year relative survival rate across all stages combined, and comprises approximately 15% of the more than 2.4 million patients who receive a diagnosis of lung cancer worldwide annually. And, according to the news release, despite initial high response rates to first-line platinum-based chemotherapy, most patients relapse within months and require further treatment.
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