Amgen reports positive Phase 3 results for Imdelltra in small cell lung cancer

Amgen has announced encouraging outcomes from a phase 3 clinical trial involving its immunotherapy, Imdelltra (tarlatamab-dlle), in the treatment of small cell lung cancer (SCLC). The DeLLphi-304 trial, a global study, aimed to evaluate the efficacy of Imdelltra against the standard-of-care (SOC) chemotherapy in patients whose cancer had advanced following platinum-based chemotherapy. This study achieved its primary objective, showing that Imdelltra led to a statistically significant and clinically significant enhancement in overall survival rates compared to those receiving SOC chemotherapy.

This trial marks a pivotal moment as DeLLphi-304 is the first phase 3 study demonstrating a significant survival benefit over chemotherapy for SCLC patients. The safety profile of Imdelltra was found to be consistent with previous findings, according to Amgen. Jay Bradner, the Executive Vice President of Research and Development at Amgen, highlighted the severity of SCLC, describing it as one of the most aggressive types of cancer, with a critical need for more effective treatments. He noted that the impressive results from DeLLphi-304 reinforce the potential of Imdelltra as a new standard of care for this challenging condition.

Globally, lung cancer affects over 2.4 million people annually, with SCLC making up roughly 15% of these cases. SCLC is recognized for its rapid progression, and although initial treatments with platinum-based chemotherapy show high response rates, the disease often relapses within months, necessitating further therapeutic options.

Imdelltra received accelerated approval from the US Food and Drug Administration (FDA) in May of the previous year for treating adults with extensive-stage SCLC who had experienced disease progression after platinum-based chemotherapy. Additionally, the drug gained approval from the UK's Medicines and Healthcare products Regulatory Agency earlier this year under the brand name Imdylltra for SCLC patients.

Bradner expressed enthusiasm about presenting these findings to the scientific community and health authorities, emphasizing Amgen's ongoing commitment to making Imdelltra accessible to patients worldwide. This announcement comes shortly after Amgen revealed new data from a late-stage trial of its B cell-depleting therapy, Uplizna (inebilizumab-cdon), targeting the rare autoimmune disorder generalized myasthenia gravis in adults. The company also reported promising results from a phase 3 program of rocatinlimab, an investigational T-cell rebalancing therapy developed in collaboration with Kyowa Kirin, for atopic dermatitis.

The promising advancements from multiple trials demonstrate Amgen's dedication to advancing innovative therapies across various medical conditions. As the company continues its efforts to bring Imdelltra to global markets, the medical community is hopeful that these new treatment options will significantly improve patient outcomes in diseases with high unmet needs.