Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer.- Genentech/Roche

The study results showed that Alecensa (alectinib) reduces the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected stage ib (tumor ?4 cm) to iiia (uicc ajcc 7th edition) anaplastic lymphoma kinase (alk)-positive non-small cell lung cancer (nsclc). a clinically meaningful improvement of central nervous system (cns)-dfs was also observed (hr="0.22;" 95% ci: 0.08-0.58). the safety and tolerability of alecensa in this trial were consistent with previous trials in the metastatic setting and no unexpected safety findings were observed. overall survival data were immature at the time of this analysis and follow-up is ongoing to report a more mature estimate.></0.0001)>

The full results of ALINA are being presented as a late-breaking oral at the European Society of Medical Oncology (ESMO) Congress 2023 Presidential Symposium on Saturday, October 21, 2023. These data will be submitted to global health authorities, including the FDA and the European Medicines Agency.

“By reducing the risk of recurrence or death of ALK-positive early-stage NSCLC by an unprecedented 76%, Alecensa can potentially alter the course of this disease as we aim to provide the best chance for cure,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We urgently need to do more to help people with lung cancer, as about half of patients with early-stage NSCLC experience disease recurrence. We’re working with health authorities to bring Alecensa to patients in this setting as soon as possible.”,/p>

“These potentially practice-changing 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,” said Professor Benjamin Solomon, Medical Oncologist, Peter MacCallum Cancer Centre, Australia. “The magnitude of disease-free survival observed in this study could represent a paradigm shift in the way we manage early-stage ALK-positive lung cancer.”

Delaying disease progression is of particular importance for people with ALK-positive NSCLC, who are generally younger – usually around 55 – and are at higher risk of developing brain metastases than those with other types of NSCLC. Once the disease returns it often spreads to other parts of the body, at which point it is usually considered incurable. Comprehensive biomarker testing is essential to helping physicians secure a complete, personalized diagnosis and identify the right treatment for each patient.

Results from the primary analysis of the ALINA study showed median DFS was not yet reached for Alecensa compared with 41.3 months for chemotherapy (95% CI: 28.5, not evaluable [NE]). Grade 3 or 4 adverse events (AEs) occurred in 30% of people receiving Alecensa, compared with 31% of those receiving chemotherapy. No Grade 5 events were observed in either treatment arm. For those receiving Alecensa, 5.5% of patients discontinued treatment due to AEs versus 12.5% in the chemotherapy arm.