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The Food and Drug Administration has approved Ensacove for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.
The Food and Drug Administration has approved Ensacove (ensartinib) for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor, the agency has announced.
The efficacy of Ensacove was demonstrated in the phase 3 eXALT3 clinical trial of 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an ALK-targeted therapy, with patients being evenly randomized to receive Ensacove or Xalkori (crizotinib).
Progression-free survival: the time a patient lives without their disease spreading or worsening.
Overall survival: the time a patient lives, regardless of disease status.
Pruritis: itchiness.
Edema: swelling caused by a buildup of fluid.
Pyrexia: fever.
Findings from the trial were published in JAMA Oncology in 2021, where Ensacove was found to result in what researchers described as a statistically significant improvement in progression-free survival (PFS) compared to Xalkori, with the median PFS times being 25.8 months and 12.7 months, respectively.
“[Ensacove] represents a new first-line treatment option for patients with ALK-positive NSCLC,” researchers stated in the study.
However, the FDA noted in its approval announcement that there was no statistically significant difference regarding overall survival.
The most common side effects experienced by at least 20% of patients were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia and fatigue.
According to the agency, the recommended dose is 225 mg orally daily, with or without food, until disease progression or unacceptable toxicity.
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Dr. Ken Culver, director of research and clinical affairs for the organization ALK Positive, told CURE® earlier this year that there are between 90 and 100 current clinical trials in the United States and the European Union allowing patients with ALK-positive NSCLC, with 15 or so being for treatments specifically designed to target ALK-positive disease.
There are approximately 10,000 new cases of ALK-positive lung cancer each year, with an average survival of seven years and approximately 70,000 patients with ALK-positive lung cancer currently living in the United States, Culver said.
ALK fusions exist in 3% to 5% of patients with NSCLC, Dr. Stephen Liu, a medical oncologist who leads the Thoracic Oncology and the Developmental Therapeutics sections at Georgetown University’s Lombardi Comprehensive Cancer Center in Washington, D.C., told CURE® previously. Their presence is not associated with a history of smoking, and ALK-positive cancers have a high likelihood of spreading to the brain.
Ensacove, researchers reported in JAMA Oncology, had an intracranial response rate of 64% among patients who had brain metastases at baseline, versus 21% of patients treated with Xalkori.
“In this randomized clinical trial, [Ensacove] showed superior systemic and intracranial efficacy compared with [Xalkori] and an overall favorable safety profile that is distinct from that of other agents in this class,” researchers stated.
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