US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its drug Imdylltra (tarlatamab). The approval is for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after at least two prior lines of therapy, including platinum-based chemotherapy.
Study Results and Approval Basis
The conditional marketing approval is supported by results from the open-label, multi-center Phase II DeLLphi-301 study. This study evaluated the efficacy of tarlatamab in ES-SCLC patients who had failed two or more prior lines of treatment. The results showed that tarlatamab, administered at a dose of 10 mg every two weeks, demonstrated an objective response rate (ORR) of 41% (95% Confidence Interval [CI]: 32 to 52) and a median duration of response (DoR) of 9.7 months. Additionally, the drug was found to be safe and tolerable overall.
Mechanism of Action
Tarlatamab is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of tumor cells and CD3 expressed on the surface of T cells. This dual-action mechanism allows for targeted engagement and activation of the immune system against cancer cells, offering a promising treatment option for patients with advanced ES-SCLC.-Fineline Info & Tech
