Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC

2024-04-19

临床3期临床结果上市批准加速审批

Pictured: Genentech's sign at its headquarters in California/iStock, Sundry Photography The FDA on Thursday greenlit the use of Genentech’s Alecensa (alectinib) for the adjuvant treatment of patients with early-stage, anaplastic lymphoma kinase-positive non-small cell lung cancer anaplastic lymphoma kinase-positive non-small cell lung cancer who have undergone tumor resection. With the approval, Alecensa is now the “first and only” ALK inhibitor ALK inhibitor approved for this indication and patient population, according to Genentech. Thursday’s regulatory win is backed by data from the Phase III ALINA trial, a randomized, active-controlled and open-label study comparing adjuvant Alecensa with platinum-based chemotherapy. The study enrolled 257 patients with Stage IB to IIIA tumors who had undergone resection and tested positive for anaplastic lymphoma kinase (ALK) using an FDA-approved test. Results from ALINA, which the company released in October 2023, showed that Alecensa could cut the risk of disease recurrence or death by 76% versus platinum-based chemotherapy. This treatment effect was highly significant and yielded a p-value of less than 0.0001. The ALK blocker also led to a significant improvement in central nervous system-disease-free survival, according to an exploratory analysis of ALINA. Genentech CMO Levi Garraway in a statement on Thursday called ALINA’s disease-free survival data “unprecedented,” adding that “Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer.” Designed to be orally available, Alecensa is a small molecule drug that works by blocking the action of the ALK protein, which in non-small cell lung cancer (NSCLC) is mutated and leads to the uncontrolled growth and proliferation of cells. According to its label, Alecensa’s mechanism of action allows the drug to disrupt downstream ALK signaling and lowering the viability of tumor cells. The FDA first approved Alecensa in December 2015 for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. The drug picked up another approval in November 2017, pushing it into the first-line setting for ALK-positive NSCLC. Thursday’s approval further expands the patient pool for Alecensa and continues Genentech’s recent rally in oncology. On Wednesday, the Roche subsidiary reported strong data for its investigational subcutaneous formulation of Ocrevus (ocrelizumab), which in the Phase III OCARINA II study resulted in the “near-complete suppression of relapse activity” in patients with relapsing or primary progressive multiple sclerosis. On Monday, Genentech also released promising Phase III data for its bispecific T-cell engager Columvi (glofitamab), which improved overall survival in patients with diffuse large B-cell lymphoma who had undergone at least one prior line of therapy. These data will allow the pharma to full approval of Columvi and potentially expand its reach to earlier lines of treatment. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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