Roche’s Genentech announces results from phase 3 ALK-positive early-stage lung cancer treatment clinical trial
Roche’s Genentech has announced that the phase 3 ALINA trial assessing Alecensa, compared with platinum-based chemotherapy for the treatment of early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), met its primary endpoint of disease-free survival (DFS).
The drug demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in patients with this indication. This means Alecensa is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death of this indication in a phase 3 trial.
Overall survival (OS) data was immature at this stage of analysis, however no unexpected safety findings were noted. Results from this trial are expected to be presented at an upcoming medical meeting and will be submitted to relevant global health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Levi Garraway MD PhD, chief medical officer and head of Global Product Development at Genentech, commented: “Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” [...] If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure, which is our ultimate goal at Genentech. We look forward to sharing this data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”