Amgen has announced the US Food and Drug Administration’s (FDA) accelerated approval for its IMDELLTRA (tarlatamab-dlle) to treat adults with extensive-stage small cell lung cancer (ES-SCLC).

A Delta-like ligand 3 (DLL3)-targeting bispecific T-cell engager (BiTE) therapy, IMDELLTRA is indicated for ES-SCLC patients who have experienced disease progression on or following platinum-based chemotherapy.

The treatment works by harnessing the patient’s own immune system to combat DLL3-expressing tumour cells.

This accelerated approval was granted following promising results from the Phase II DeLLphi-301 clinical trial.

The trial assessed IMDELLTRA in SCLC patients who had previously failed two or more lines of therapy and were given 10mg doses of IMDELLTRA every two weeks (Q2W).

According to the trial findings, an objective response rate (ORR) of 40% and a median duration of response (DoR) of 9.7 months following IMDELLTRA treatment were reported.

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While the median overall survival (mOS) was recorded at 14.3 months, the final survival data is still pending.

Anaemia, constipation, cytokine release syndrome (CRS), dysgeusia, fatigue, musculoskeletal pain, nausea, pyrexia and reduced appetite were the most common adverse reactions reported in patients treated with IMDELLTRA.

Amgen research and development executive vice-president Jay Bradner and chief scientific officer said: “The FDA’s approval of IMDELLTRA marks a pivotal moment for patients battling ES-SCLC.

This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients.

“This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved BiTE molecule.”

Earlier this month, Amgen reported that its total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year.