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Amgen has said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) conditional approval of Imdylltra (tarlatamab) for extensive-stage small cell lung cancer (ES-SCLC) marks a “significant step forward” for those with lung cancer.
Adults with ES-SCLC who have not responded to at least two prior lines of therapy, including platinum-based chemotherapy, will be eligible for the antineoplastic treatment, as per a 6 January press release by Amgen. The therapy was approved by the MHRA on 31 December.
In the announcement, Amgen’s UK and Ireland executive medical director Tony Patrikios said: “There is a vital need for novel treatments, particularly for the extensive stage of small cell lung cancer, where outcomes are especially poor.”
Shares in the company have remained level since the authorisation, though are still down from 2024 highs in August, primarily due to disappointing data from its weight loss drug MariTide.
Imdylltra’s conditional marketing authorisation – a type of approval given where clinical data is not yet complete but is judged to be available soon – was based on results from the Phase II DeLLphi-301 trial (NCT05060016). Administered intravenously every two weeks at 10mg, Imdylltra led to an objective response rate (ORR) of 41% and a median duration of response (DoR) of 9.7 months.
SCLC is an aggressive disease subtype and accounts for 15% of patients with lung cancer, being less common than non-small-cell lung cancer (NCSLC). ES-SCLC has a median survival of around 9-12 months. While first-line platinum-based chemotherapy is initially effective, relapse is frequent after a few months of treatment. Amgen states that median overall survival is around 26 weeks with current second-line treatments, with third-line options lacking.
Imdylltra is a bispecific T-cell engager (BiTE) that targets the protein delta-like ligand 3 (DLL3) in tumour cells. It also binds to T-cells, causing the drug to trigger immune pathways that lead to the lysis of tumour cells. The US Food and Drug Administration (FDA) approved tarlatamab, under the brand name Imdelltra, in May 2024, making Amgen’s drug the first and only T-cell engager therapy for ES-SCLC treatment.
Imdylltra is globally forecast to generate $217m this year, with it reaching blockbuster status by 2029, according to GlobalData’s Pharma Intelligence Centre.
GlobalData is the parent company of Pharmaceutical Technology.
Whilst Imdylltra has produced promising efficacy, the treatment does come with side effects. The FDA label for the drug includes a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity. Warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity are also included.