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An expert explained the importance of the FDA’s approval of Ensacove for patients with ALK-positive non-small cell lung cancer.
Ensacove (ensartinib) has been approved by the Food and Drug Administration (FDA) for 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.
Ensacove’s efficacy was displayed in the phase 3 eXALT3 clinical trial of 290 patients with locally advanced or metastatic ALK-positive NSCLC who were naïve to prior ALK-targeted therapy. Patients received either Ensacove or Xalkori (crizotinib).
According to findings from the trial published in JAMA Oncology in 2021, Ensacove resulted in improvement in progression-free survival (PFS) compared to Xalkori, with the median PFS times being 25.8 months and 12.7 months, respectively.
The most common side effects experienced by at least 20% of patients were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia and fatigue.
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.
As part of the “Speaking Out” video series, CURE® spoke with Andrew Ciupek, associate director of clinical research at GO2 for Lung Cancer, about the FDA’s approval of Ensacove.
“This is a new targeted therapy approval for ALK-positive non-small cell lung cancer, and this is actually approved for treatment either as a first treatment after newly diagnosed or if you've been treated but you haven't received a prior ALK-targeted therapy,” Ciupek said. “So, there are other targeted therapies that have been improved for ALK[-positive NSCLC], but this is an additional kind of tool in the arsenal.”
Providers, as Ciupek explained, are still sorting out the best use for Ensacove.
“I think it's interesting in that we're still understanding how best this would fit in, which types of patients are most likely to benefit from Ensacove, as opposed to other types of ALK-targeted therapies,” he said. “But I think the take-home message for people in the ALK community is that this is a another targeted therapy that we have in our toolbox, adding to the number of targeted therapies are already approved for ALK, and you can be offered different options based on what you and your doctor discuss.”
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