Genentech’s Alecensa shows promise in Phase III ALINA study for early-stage ALK-positive NSCLC

Genentech, a Roche Group member, has announced positive results from its Phase III ALINA study evaluating Alecensa (alectinib), setting a new standard for treating early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Meeting its primary endpoint of disease-free survival (DFS), Alecensa showed a statistically significant and clinically meaningful improvement compared to platinum-based chemotherapy. This marks Alecensa as the first ALK inhibitor to reduce the risk of disease recurrence or death in a Phase III trial for early-stage ALK-positive NSCLC.

CMO Highlights Alecensa’s Pivotal Role in Addressing Unmet Needs in ALK-Positive NSCLC

Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, stated, “Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC. Now, these strong results offer evidence that Alecensa can also play a pivotal role in early-stage disease where there is a significant unmet need.” Genentech aims to submit the ALINA study results to global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

ALK-Positive NSCLC: The Current Landscape and Unmet Needs

Despite advances in adjuvant chemotherapy and immunotherapies, approximately half of all patients with early-stage NSCLC face a recurrence post-surgery. There are no approved ALK inhibitors for treating early-stage ALK-positive NSCLC, which affects about 5% of NSCLC patients. Often affecting younger individuals under 55, this ALK-positive subset represents a crucial area for treatment development.

Details of the ALINA Study and Alecensa’s Potential Impact

The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label trial involving 257 patients with completely resected Stage IB to IIIA ALK-positive NSCLC. Compared to platinum-based chemotherapy, Alecensa demonstrated significant DFS improvement, making it a potential game-changer in the treatment landscape. Overall survival (OS) data are still immature, but no unexpected safety findings were reported.

Alecensa Aims for Swift Regulatory Approval to Meet Urgent Patient Needs

The ALINA study’s positive results will be presented at an upcoming medical conference and submitted to global health authorities. Genentech aims to expedite the process to get Alecensa approved as a new standard of care for early-stage ALK-positive NSCLC patients, thereby fulfilling a significant unmet need in oncology.