Amgen has shared positive results from a late-stage study of its immunotherapy Imdelltra (tarlatamab-dlle) in small cell lung cancer (SCLC).
The global DeLLphi-304 trial has been comparing the drug against local standard-of-care (SOC) chemotherapy in SCLC patients who had progressed on or after a single line of platinum-based chemotherapy.
The trial met its primary endpoint, with Imdelltra demonstrating a statistically significant and clinically meaningful improvement in overall survival compared to SOC chemotherapy.
Amgen said DeLLphi-30 is the first phase 3 trial to show a substantial survival advantage over chemotherapy for this patient population, adding that the safety of Imdelltra was consistent with its known profile.
Jay Bradner, executive vice president, research and development, Amgen, said: “SCLC is one of the most aggressive malignancies, with a high unmet need for more effective therapies.
“The top-line results from DeLLphi-304 demonstrate overwhelming clinical benefit for people living with this devastating disease and affirm Imdelltra as SOC.”
More than 2.4 million people are diagnosed with lung cancer globally every year, with SCLC accounting for approximately 15% of all cases. The disease progresses rapidly and, despite initial high response rates to first-line platinum-based chemotherapy, most SCLC patients relapse within months and require subsequent treatment options.
Amgen’s Imdelltra was granted accelerated approval by the US Food and Drug Administration in May last year to treat extensive-stage SCLC in adults with disease progression on or after platinum-based chemotherapy.
The drug was also approved by the Medicines and Healthcare products Regulatory Agency earlier this year for SCLC under the brand name Imdylltra.
“We look forward to sharing these results with the scientific community and health authorities as we continue our efforts to bring Imdelltra to patients worldwide,” Bradner said.
The announcement comes just one month after Amgen unveiled new data from a late-stage trial of its B cell-depleting therapy Uplizna (inebilizumab-cdon) in adults with the rare autoimmune disorder generalised myasthenia gravis.
The company also recently shared promising results from a phase 3 programme of its Kyowa Kirin-partnered investigational T-cell rebalancing therapy rocatinlimab in atopic dermatitis.