Amgen’s Imdelltra (tarlatamab-dlle) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat extensive-stage small cell lung cancer (SCLC).
The immunotherapy has been specifically authorised for use in adults with disease progression on or after platinum-based chemotherapy.
More than 234,000 new cases of lung cancer are expected to be diagnosed in the US this year, with SCLC accounting for approximately 15% of all diagnoses.
SCLC progresses rapidly and about 70% of newly diagnosed patients have extensive-stage disease, meaning their cancer has spread to both lungs and/or beyond the lungs to other parts of the body.
The DLL3 protein is expressed on the surface of SCLC cells in the majority of patients and is minimally expressed on healthy cells, which Amgen says makes it an “exciting target”.
Imdelltra is the first and only DLL3-targeting bispecific T-cell engager therapy that activates the patients’ own T cells to attack DLL3-expressing tumour cells.
The FDA’s decision was supported by positive results from the mid-stage DeLLphi-301, which evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment.
A 10mg dose of Imdelltra every two weeks demonstrated an objective response rate of 40%, a median duration of response of 9.7 months, and a median overall survival of 14.3 months.
Jay Bradner, executive vice president, research and development, and chief scientific officer at Amgen, described the approval as a “pivotal moment” for patients with extensive-stage SCLC.
“Imdelltra offers these patients who are in urgent need of new innovative therapies hope, and we’re proud to deliver this long-awaited, effective treatment to them,” Bradner said.
The FDA authorised Imdelltra through Project Orbis, a global partnership between regulatory bodies to review and approve promising cancer drugs. The application reviews are ongoing at the other regulatory agencies involved in the initiative.
Commenting on the US regulator’s decision on the therapy, Laurie Fenton Ambrose, co-founder, president and chief executive officer of GO2 for Lung Cancer, said: “After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available.
“[The] FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease.”