European Commission Grants Approval for Amgen's IMDYLLTRA® to Treat Advanced Small Cell Lung Cancer
On June 3, 2026, Amgen (NASDAQ:AMGN) announced that the European Commission (EC) has granted marketing authorization for IMDYLLTRA® (tarlatamab). This breakthrough therapy is now approved as a monotherapy for adults with extensive-stage small cell lung cancer (ES-SCLC) who need systemic treatment following disease progression during or after first-line platinum-based chemotherapy.
This approval is based on the Phase 3 DeLLphi-304 trial results, which demonstrated a remarkable 40% reduction in the risk of death when using IMDYLLTRA compared to standard chemotherapy. The trial indicated a significant increase in median overall survival (OS) of over five months (13.6 months vs. 8.3 months) for patients who had previously progressed after platinum-based chemotherapy, with a hazard ratio of 0.60, indicating strong efficacy (P < 0.001).
Jean-Charles Soria, Senior Vice President of Oncology at Amgen, remarked, "Small cell lung cancer is one of the most aggressive solid tumors, often resulting in a high recurrence rate after initial treatment with limited options thereafter. The EC’s approval of IMDYLLTRA, the first and only T-cell therapy approved for small cell lung cancer, marks a pivotal advancement for patients in Europe, emphasizing our commitment to advancing innovative medicines that can dramatically enhance outcomes for those living with this devastating disease."
The DeLLphi-304 study showcased that IMDYLLTRA resulted in a 40% reduction in the risk of death, significantly improving median OS compared to standard chemotherapy in patients undergoing treatment after failed therapies. This research has been an important contribution to the oncology field, highlighting the urgent need for continued innovation in small cell lung cancer treatments.
Debra Montague, President of Lung Cancer Europe (LuCE), added, "Historically, patients with small cell lung cancer face a challenging journey once they progress after initial treatment, often surviving only a few months. The approval of a new treatment option for people in Europe living with this challenging cancer is a significant step forward and underscores the urgent need for innovation in lung cancer treatment."
IMDYLLTRA’s safety profile was consistent with previous known data. The most frequently reported adverse reactions included cytokine release syndrome (CRS) (56.7%), decreased appetite (36.4%), fever (31.9%), dysgeusia (31.3%), constipation (30.4%), anemia (30.0%), fatigue (29.8%), nausea (24.9%), asthenia (19.0%), neutropenia (16.9%), hyponatremia (16.7%), headache (16.3%), and lymphopenia (15.6%). Severe adverse reactions, notably CRS, occurred in 19.7% of patients. Notably, CRS typically manifested after the first two doses of IMDYLLTRA, necessitating careful monitoring during the initial treatment phases.
Amgen’s extensive clinical program for IMDYLLTRA includes several ongoing trials evaluating its efficacy not only as a monotherapy but also in combination therapy settings across various stages and lines of small cell lung cancer treatment. This dedication to research exemplifies Amgen’s commitment to addressing those unmet needs within the oncology landscape, particularly for aggressive cancers like small cell lung cancer.
Small cell lung cancer is known for being one of the most aggressive forms of solid tumor cancers, accounting for about 13-15% of over 2.4 million lung cancer cases diagnosed globally each year. While initial chemotherapy based on platinum has shown high response rates, most patients experience a rapid relapse within months, necessitating the need for effective subsequent treatment options.
The approval of IMDYLLTRA® by the European Commission marks a pivotal moment in the fight against small cell lung cancer, providing hope to countless patients who face dire prospects. As we continue to forge ahead in the realm of oncology, we remain committed to providing therapies that will not only extend life but also enhance the quality of life for patients battling this aggressive disease.
This approval is based on the Phase 3 DeLLphi-304 trial results, which demonstrated a remarkable 40% reduction in the risk of death when using IMDYLLTRA compared to standard chemotherapy. The trial indicated a significant increase in median overall survival (OS) of over five months (13.6 months vs. 8.3 months) for patients who had previously progressed after platinum-based chemotherapy, with a hazard ratio of 0.60, indicating strong efficacy (P < 0.001).
Jean-Charles Soria, Senior Vice President of Oncology at Amgen, remarked, "Small cell lung cancer is one of the most aggressive solid tumors, often resulting in a high recurrence rate after initial treatment with limited options thereafter. The EC’s approval of IMDYLLTRA, the first and only T-cell therapy approved for small cell lung cancer, marks a pivotal advancement for patients in Europe, emphasizing our commitment to advancing innovative medicines that can dramatically enhance outcomes for those living with this devastating disease."
The DeLLphi-304 study showcased that IMDYLLTRA resulted in a 40% reduction in the risk of death, significantly improving median OS compared to standard chemotherapy in patients undergoing treatment after failed therapies. This research has been an important contribution to the oncology field, highlighting the urgent need for continued innovation in small cell lung cancer treatments.
Debra Montague, President of Lung Cancer Europe (LuCE), added, "Historically, patients with small cell lung cancer face a challenging journey once they progress after initial treatment, often surviving only a few months. The approval of a new treatment option for people in Europe living with this challenging cancer is a significant step forward and underscores the urgent need for innovation in lung cancer treatment."
IMDYLLTRA’s safety profile was consistent with previous known data. The most frequently reported adverse reactions included cytokine release syndrome (CRS) (56.7%), decreased appetite (36.4%), fever (31.9%), dysgeusia (31.3%), constipation (30.4%), anemia (30.0%), fatigue (29.8%), nausea (24.9%), asthenia (19.0%), neutropenia (16.9%), hyponatremia (16.7%), headache (16.3%), and lymphopenia (15.6%). Severe adverse reactions, notably CRS, occurred in 19.7% of patients. Notably, CRS typically manifested after the first two doses of IMDYLLTRA, necessitating careful monitoring during the initial treatment phases.
Amgen’s extensive clinical program for IMDYLLTRA includes several ongoing trials evaluating its efficacy not only as a monotherapy but also in combination therapy settings across various stages and lines of small cell lung cancer treatment. This dedication to research exemplifies Amgen’s commitment to addressing those unmet needs within the oncology landscape, particularly for aggressive cancers like small cell lung cancer.
Small cell lung cancer is known for being one of the most aggressive forms of solid tumor cancers, accounting for about 13-15% of over 2.4 million lung cancer cases diagnosed globally each year. While initial chemotherapy based on platinum has shown high response rates, most patients experience a rapid relapse within months, necessitating the need for effective subsequent treatment options.
The approval of IMDYLLTRA® by the European Commission marks a pivotal moment in the fight against small cell lung cancer, providing hope to countless patients who face dire prospects. As we continue to forge ahead in the realm of oncology, we remain committed to providing therapies that will not only extend life but also enhance the quality of life for patients battling this aggressive disease.
Topics Health）
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