Over 50% of non-small cell lung cancer patients (NSCLC) will experience a recurrence after surgery. The cancer recurs even after adjuvant chemotherapy after major surgery.
ALINA’s data show that Alecensa has been successful in reducing a recurrence for people with ALK-positive NSCLC. Even if the primary surgery was successful, sometimes microscopic cancers remain that cannot be detected under current procedures.
Currently, no ALK inhibitors have been approved to treat early ALK-positive patients. Approximately 5% of NSCLC patients are ALK-positive and found mostly in younger people.
Genentech, reporting recently through Business Wire, issued a statement regarding its Phase III ALINA study (NCT03456076) that evaluated Alecensa® by comparing it with platinum-based chemotherapy.
The ALINA study involved 257 people who were assigned randomly to either the control or the investigational treatment arm.
Disease-free survival is the primary endpoint. The secondary measures are overall survival and the number of patients who have experienced adverse events.
Alecensa was evaluated at a specific interim period and found to have met its primary endpoint. Alecensa showed an improvement in disease-free survival when used after surgery to treat people with stage 1B to IIIA anaplastic lymphoma kinase (ALK) NSCLC.
Alecensa, through its Phase III trial, has emerged as the only available ALK inhibitor that reduces the risk of death or recurrence in patients who have early-stage ALK-positive NSCLC.
Alecensa has been used for the treatment of patients who have NSCLC that has spread (metastasized) and is caused by an abnormal ALK gene.
Data on overall survival were premature at this time. No unexpected safety occurrences were observed.
ALINA study results will be submitted to global health authorities such as the FDA and EMA.
Dr. Levi Garraway, who heads Global Products at Genentech, said that Alecensa demonstrates the potential for successful treatment prior to the cancer metastasizing.
The ACS estimates that over 238,000 people in the U.S. will receive a lung cancer diagnosis in 2023. NSCLC represents about 80 to 85% of all lung cancers.
The best opportunity to cure lung cancer is early detection.
