Amgen’s lung cancer treatment gets conditional approval

IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation for IMDYLLTRA (tarlatamab), a new treatment for extensive-stage small cell lung cancer (ES-SCLC).

This decision marks a significant step forward for patients whose disease has progressed after at least two prior lines of therapy, including platinum-based chemotherapy.

Small cell lung cancer (SCLC) is an aggressive form of lung cancer, accounting for around 15% of all lung cancer cases in the UK. Patients with ES-SCLC face particularly poor outcomes, making new treatments like IMDYLLTRA® crucial.

“The MHRA’s granting of a conditional marketing authorisation for tarlatamab is a significant step forward for people living with small cell lung cancer,” said Tony Patrikios, Executive Medical Director, Amgen UK & Ireland.

“There is a vital need for novel treatments, particularly for the extensive stage of small cell lung cancer, where outcomes are especially poor,” he added.

The approval is based on the Phase 2 DeLLphi-301 study, which evaluated tarlatamab in patients who had previously failed at least two other treatments.

The study found an objective response rate (ORR) of 41% and a median duration of response of 9.7 months.

“Extensive-stage small cell lung cancer is an extremely difficult cancer to treat. While initial response rates to current treatment of chemotherapy, with the addition of radio- and immunotherapy, are high, duration of response is often short. Subsequent current treatments have had low success rates,” said Professor Alastair Greystoke of Newcastle University.

IMDYLLTRA works by targeting DLL3 expressed on the surface of tumour cells and CD3 on T cells, triggering T-cell activation and tumour cell destruction. Common side effects include cytokine release syndrome, pyrexia, and dysgeusia.

The conditional marketing authorisation allows further monitoring of the drug’s safety and efficacy, bringing new hope to patients battling ES-SCLC.