Roche Claims ‘Unprecedented’ Phase III NSCLC Victory for Oral ALK Inhibitor Alecensa

Roche_iStock, JHVEPhoto

Pictured: Roche's facility in California/iStock, JHVEPhoto

Roche‘s Genentech on Wednesday revealed results from the Phase III ALINA study, showing that its oral ALK inhibitor Alecensa (alectinib) met the study’s primary endpoint of disease-free survival in patients with a specific type of non-small cell lung cancer.

Compared with platinum-based chemotherapy, Alecensa treatment reduced the risk of disease recurrence or death by 76%. This effect was highly statistically significant, with a p-value less than 0.0001, according to Genentech’s announcement on Wednesday. Alecensa also induced a clinically meaningful improvement in central nervous system disease-free survival (DFS).

Levi Garraway, CMO and head of global product development at Genentech, called the magnitude of Alecensa’s effect on DFS “unprecedented” in a statement.

The company also noted that these data are “the first and only” to demonstrate a significant improvement in DFS in early stage ALK-positive and resected non-small cell lung cancer (NSCLC).

Benjamin Solomon, an oncologist at the Peter MacCallum Cancer Centre in Australia, said in a statement that the “data reinforce the potential of Alecensa as a new standard of care in the ALK-positive early lung cancer setting where treatment options are currently extremely limited” and “represent a paradigm shift.”

Roche will present full results from and analysis of ALINA during upcoming European Society of Medical Oncology (ESMO) Congress 2023. The pharma group will also discuss these data with the FDA and other regulatory authorities worldwide.

ALINA is a randomized and open-label study that compared Alecensa with an active control group of patients treated with platinum-based chemotherapy. The study focused its enrollment on patients with completely resected Stage IB to IIIA NSCLC who are positive for the anaplastic lymphoma kinase. A total of 257 eligible patients are participating in the study.

The primary endpoint in ALINA is DFS, the median duration of which had not yet been reached at the time of the current preliminary analysis. In comparison, median DFS in the chemotherapy control arm is 41.3 months. Data for overall survival, a key secondary endpoint, is still immature and the study will continue to obtain a more mature estimate for this metric.

In addition to efficacy, ALINA assessed Alecensa’s safety in this patient population and found that the frequency of grade 3 or 4 adverse events was comparable between the Alecensa and chemotherapy arms, with respective rates of 30% and 31%. Around 12% of patients in the chemotherapy control group dropped out due to side effects, compared to only 5.5% in the Alecensa arm.

Wednesday’s data reveal for ALINA comes as an embargo on ESMO abstracts was breached earlier this week. This pushed the meeting’s organizers to make all late-breaking abstracts available ahead of schedule. As a result, several other companies unveiled promising NSCLC data including BMS, Mirati, BeiGene and J&J.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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