The European Commission (EC) has granted approval for Roche’s Alecensa (alectinib) as the first adjuvant treatment for adults with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following tumor resection with a high risk of recurrence. This landmark decision follows the U.S. Food and Drug Administration (FDA) approval for the same indication in April 2024.
Clinical Trial Success
The approval is based on the successful outcomes of the Phase III ALINA clinical trial, a pivotal study that evaluated the safety and efficacy of adjuvant Alecensa compared to platinum-based chemotherapy. This active-controlled, randomized, open-label, multicenter trial involved 257 patients who were randomly assigned to receive either Alecensa or chemotherapy, with the primary endpoint being disease-free survival.
Results from the trial were compelling, showing that Alecensa reduced the risk of disease recurrence or mortality by 76% compared to chemotherapy. Additionally, an exploratory analysis suggested that Alecensa improved central nervous system (CNS) disease-free survival, a significant benefit for ALK-positive NSCLC patients who are prone to developing brain metastases.
Safety and Efficacy
The safety profile of Alecensa in this trial was consistent with previous studies, with no unexpected safety concerns reported. Alecensa has already been widely recognized as a preferred treatment for advanced ALK-positive NSCLC, having been used to treat over 94,000 patients with advanced disease globally.
Broader Implications
Levi Garraway, Roche’s Global Product Development head and Chief Medical Officer, emphasized the significance of this approval, stating, “For the first time, people in Europe who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, which can significantly reduce the risk of disease recurrence or death. This is a landmark approval for people who have historically faced a high risk of their cancer returning after surgery. We are now able to bring the transformational benefits of Alecensa to even more people with ALK-positive lung cancer.”
Future Prospects
Following the EC approval, Roche is committed to making Alecensa available to more patients worldwide by seeking approvals from additional health authorities. This approval is seen as a significant step forward in improving outcomes for patients with ALK-positive NSCLC.
FDA’s Priority Review for Inavolisib
In a related development, the FDA granted a priority review in May 2024 for Roche’s inavolisib as a combination therapy with fulvestrant and Pfizer’s Ibrance (palbociclib) for the treatment of breast cancer. This demonstrates Roche’s continued commitment to advancing cancer treatments and expanding therapeutic options for patients.
Conclusion
The EC’s approval of Alecensa marks a critical advancement in the treatment of ALK-positive NSCLC, offering new hope to patients with a high risk of recurrence post-surgery. With its proven efficacy and safety profile, Alecensa stands to transform the standard of care and significantly improve patient outcomes in Europe and beyond.
Related: Roche’s Alecensa Receives EU Approval for ALK-Positive NSCLC Treatment