Amgen's IMDYLLTRA® (tarlatamab) Receives Conditional UK Approval for Third-Line Treatment of Extensive-Stage Small Cell Lung Cancer

10 January 2025
Amgen has announced the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally approved IMDYLLTRA for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) that has progressed following at least two prior therapies, including platinum-based chemotherapy. Small cell lung cancer (SCLC) is a particularly aggressive form of lung cancer, contributing to roughly 15% of all cases. This type of cancer is known for its rapid spread and growth, often being diagnosed at advanced stages due to late-onset symptoms.

The conditional marketing authorisation for tarlatamab, branded as IMDYLLTRA, marks a noteworthy development for individuals battling small cell lung cancer. Tony Patrikios, Executive Medical Director at Amgen UK & Ireland, highlighted the urgency for innovative treatments, especially for ES-SCLC, where outcomes are generally poor. More than 34,000 individuals die from lung cancer in the UK annually, underscoring the necessity for new therapeutic options. This new licence is a step closer to offering a novel treatment to those eligible.

The approval is based on the findings of the Phase 2 DeLLphi-301 study, an open-label, multicentre investigation of tarlatamab in ES-SCLC patients who had not responded to two or more previous treatments. The study revealed that a dose of 10 mg every two weeks resulted in an objective response rate of 41% and a median duration of response of 9.7 months. Professor Alastair Greystoke from Newcastle University noted the challenges in treating ES-SCLC, where initial responses to chemotherapy combined with radio- and immunotherapy are positive but often short-lived. Alternatives for subsequent treatment phases have shown limited success.

IMDYLLTRA is a bispecific DLL3-directed CD3 T-cell engager. It works by attaching to DLL3 on tumour cells and CD3 on T cells, thereby activating T cells, which then produce inflammatory cytokines and cytotoxic proteins to destroy tumour cells. The most frequently reported side effects of tarlatamab include cytokine release syndrome, fever, altered taste, reduced appetite, constipation, fatigue, anaemia, and weakness. Other common side effects are nausea, low sodium levels, and difficulty breathing.

The conditional marketing authorisation by the MHRA means more data is expected for this medicinal product, which also requires additional monitoring to quickly identify any new safety information. Healthcare professionals are encouraged to report any suspected adverse reactions.

Small cell lung cancer is one of the most aggressive solid tumour types, making up about 15% of the 49,000 lung cancer cases diagnosed annually in the UK. Patients with ES-SCLC have a median survival rate of approximately 9 to 12 months, with less than a 2% five-year relative survival rate. Although patients initially respond well to first-line platinum-based chemotherapy, they often experience relapse, necessitating further treatment options. Current second-line treatments offer limited survival benefits, and there are few third-line options available.

IMDYLLTRA is specifically indicated in the UK for treating adults with ES-SCLC where the disease has progressed after at least two previous therapies, including platinum-based chemotherapy. Amgen, a biotechnology pioneer since 1980, focuses on serving patients with a broad pipeline of medicines for various conditions, including cancer and rare diseases. In the UK, the company continues to push the boundaries of medical innovation, employing around 650 people and striving to offer sustainable health solutions.

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