Small cell lung cancer often responds initially to chemotherapy, but relapses are common and secondary treatment options can offer limited benefits. This was taken into consideration in the recent FDA approval of a promising new drug from biopharma giant Amgen, providing these complex patients with one more potential treatment option.
The drug, known as tarlatamab, has been granted approval for use in adults experiencing progression of extensive-stage small cell lung cancer after initial treatment with platinum-based chemotherapy. The green light from FDA arrived ahead of schedule, and Amgen intends to market the drug under the brand name Imdelltra.
Small cell lung cancer (SCLC) is less prevalent than its non-small variant, but presents a more aggressive threat, often spreading rapidly throughout the body. The American Cancer Society reports a sobering five-year survival rate for extensive-stage SCLC of a mere 3%. Repeat chemotherapy treatments and checkpoint inhibitor immunotherapies form the mainstay of second-line treatments, designed to check proteins that help cancers evade detection by our immune systems.
The newly approved Imdelltra moves to fight SCLC in a different way. As a bispecific T cell engager, the drug is designed to simultaneously bind to a T cell and a cancer cell, activating the immune cell to destroy the cancer cell. This marks Amgen’s second FDA-approved drug of this type, the first being Blincyto, used in certain types of leukemia. The prime target of Imdelltra is DLL3, a protein usually found in abundance on the surface of small cell lung cancer cells. The drug is administered every two weeks as a one-hour IV infusion, following step-up dosing.
The approval was accelerated by the FDA based on promising results from an open-label Phase 2 clinical trial involving over 200 patients whose SCLC had resisted two or more earlier rounds of therapy. In the trial, which saw these results published in the New England Journal of Medicine last October, the overall response rate to the approved 10 mg dose was 40% among 99 patients. The median duration of response was 9.7 months at this dosage, and the nine-month overall survival rate was observed to be 68%.
As part of the mandate for accelerated approval, Amgen will carry out further clinical testing to confirm the drug’s safety and efficacy. A Phase 3 study is already under way comparing Imdelltra to standard chemotherapy as a second-line SCLC treatment, and further Phase 3 studies are planned. This includes investigations of Imdelltra as a monotherapy and as a treatment combination with AstraZeneca’s checkpoint inhibitor Imfinzi. Meanwhile, a Phase 1b study is evaluating the potential use of the drug in combating neuroendocrine prostate cancer, a particularly aggressive form of prostate cancer.
Paying close attention to the new drug’s efficacy, safety, and pricing will be a top priority for legal professionals representing big corporations and law firms in the pharmaceutical and healthcare industry. This latest development stands as yet another example of novel approaches to cancer treatment, signaling potential shifts in regulatory, patent, and health law landscapes alike. With Amgen’s conference call scheduled to delve into the Imdelltra approval, further updates can be expected on this key newest addition to the fight against small cell lung cancer.