THOUSAND OAKS, Calif., June 1, 2026
Amgen has secured a major regulatory milestone with the European Commission approval of IMDYLLTRA® (tarlatamab) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed following first-line platinum-based chemotherapy. The approval marks a significant advancement in the treatment landscape for one of the most aggressive and difficult-to-treat forms of lung cancer and introduces the first and only T-cell engager therapy approved for small cell lung cancer in Europe. The decision was supported by compelling results from the pivotal Phase 3 DeLLphi-304 clinical trial, which demonstrated a remarkable 40% reduction in the risk of death compared with standard chemotherapy. The approval provides a new treatment option for patients facing limited therapeutic alternatives and reinforces the growing role of immunotherapy-driven precision medicine in oncology. Patients with relapsed extensive-stage small cell lung cancer have historically faced poor outcomes, making this regulatory achievement particularly significant for the global cancer community.
Phase 3 Trial Demonstrates Significant Survival Advantage
The European Commission approval was based on findings from the global Phase 3 DeLLphi-304 study, the first late-stage trial to demonstrate a statistically significant survival benefit over chemotherapy in previously treated extensive-stage small cell lung cancer. The study enrolled 509 patients whose disease had progressed after platinum-based chemotherapy and compared IMDYLLTRA with standard-of-care chemotherapy regimens. Results showed that patients receiving IMDYLLTRA achieved a median overall survival of 13.6 months, compared with 8.3 months among patients receiving chemotherapy.
This translated into a 40% reduction in mortality risk, representing one of the most meaningful advances in the treatment of relapsed small cell lung cancer in recent years. The trial also demonstrated clinically relevant improvements across key efficacy endpoints, reinforcing the therapeutic value of IMDYLLTRA in a patient population with historically limited treatment options and poor long-term survival prospects.
First-in-Class T-Cell Engager Targets DLL3-Expressing Tumors
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IMDYLLTRA represents a breakthrough in cancer immunotherapy through its innovative bispecific T-cell engager mechanism. The therapy is engineered to simultaneously bind DLL3, a protein expressed on up to 96% of small cell lung cancer cells, and CD3 receptors on T cells, enabling the immune system to directly identify and destroy cancer cells. By bringing T cells into close proximity with DLL3-expressing tumors, IMDYLLTRA creates a targeted immune response that selectively attacks malignant cells while minimizing effects on healthy tissue.
This novel mechanism differentiates the therapy from conventional chemotherapy approaches and highlights the expanding role of targeted immunotherapies in oncology. Researchers believe DLL3 represents one of the most promising therapeutic targets in small cell lung cancer, and the approval of IMDYLLTRA validates years of research aimed at harnessing immune-mediated tumor destruction for this highly aggressive disease.
Expanding Treatment Options for a Devastating Cancer
Small cell lung cancer accounts for approximately 13% to 15% of all lung cancer diagnoses worldwide and is characterized by rapid progression, high relapse rates, and poor survival outcomes. Although many patients initially respond to platinum-based chemotherapy, the majority experience disease recurrence within months and require additional treatment options. The approval of IMDYLLTRA provides physicians across Europe with a new therapeutic tool capable of extending survival and improving clinical outcomes. Amgen continues to advance an extensive development program evaluating IMDYLLTRA both as a monotherapy and in combination regimens across earlier stages of disease and multiple treatment settings.
Ongoing Phase 3 studies are investigating the therapy in first-line extensive-stage small cell lung cancer, maintenance therapy settings, and limited-stage disease. With the European Commission approval now secured, IMDYLLTRA is positioned to become an important component of future lung cancer treatment strategies and further strengthen the role of immunotherapy in precision oncology. The approval also reflects Amgen’s continued commitment to developing innovative therapies that address significant unmet needs and improve survival outcomes for patients facing some of the world’s most challenging cancers.
Source: Amgen press release
