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Roche Eyeing Adjuvant Indication for Alecensa in ALK-Positive Early Lung Cancer

NEW YORK – Roche on Friday said it will submit to health regulators in the US, Europe, and other countries data from the Phase III ALINA trial that demonstrates Alecensa's (alectinib) potential as an adjuvant treatment for patients with early-stage ALK-positive non-small cell lung cancer.

In the ALINA trial, Roche subsidiary Genentech compared Alecensa to platinum-based chemotherapy in around 250 patients with completely resected stage IB to IIIA ALK-positive NSCLC. Patients who received the ALK inhibitor as adjuvant therapy had a statistically significant and clinically meaningful improvement in disease-free survival, the trial's primary endpoint, over the comparator arm. Overall survival data are not yet mature, according to Roche. Investigators observed no unexpected safety signals.

"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 a significant unmet need," Levi Garraway, Roche chief medical officer and head of global product development, said in a statement. "We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible."

Approximately five percent of patients with NSCLC are ALK-positive. These tumors typically occur in individuals who are nonsmokers and younger than 55 years old.

Although patients with advanced or metastatic ALK-positive NSCLC have multiple targeted treatment options available to them, including Alecensa, these drugs aren't approved for use in patients with earlier stage disease. The National Comprehensive Cancer Network recommends patients with Stage IB to IIIA/B NSCLC as well as more advanced disease receive biomarker testing for relevant targetable biomarkers, such as ALK rearrangements and EGFR mutations.

If regulatory authorities approve Roche's Alecensa as an adjuvant treatment for early-stage NSCLC, it will be the second molecularly targeted treatment to move into this setting. The US Food and Drug Administration approved AstraZeneca's Tagrisso (osimertinib) in 2020 as an adjuvant treatment for EGFR-mutated non-small cell lung cancer patients based on data showing the EGFR inhibitor improved disease-free survival over chemotherapy.