Currently, almost half the patients with non-small cell lung cancer (NSCLC) will see their disease return despite aggressive chemotherapy treatment (adjuvant surgery).
Adjuvant therapy is treatment that is given after primary therapy with the goal of preventing the cancer’s return. There is an urgent need for new treatments.
Genentech Pharmaceuticals, a Roche Group member, recently announced its Phase 3 ALINA study comparing Alecensa against platinum-based chemotherapy. Alecensa has met its study endpoint.
The drug achieved disease-free survival (DFS) at the prescribed time period during the interim analysis. The announcement was recently carried by BioSpace and will be presented at medical meetings in the near future. It is also being globally presented to health authorities including the FDA and the EMA.
May Reduce the Risk of Disease Recurrence
Alecensa, used as adjuvant therapy, was able to demonstrate an improvement in DFS when administered to people who had Stage IB anaplastic lymphoma kinase (ALK) positive NSCLC.
Alecensa, an ALK inhibitor now in a Phase 3 trial, is the only one of its kind to bring about a reduction in death or disease recurrence in the early stages of ALK-positive NSCLC.
If the drug is approved, it has shown the potential to prevent the spread of cancer in its early stages. According to Dr. Levi Garraway, CMO of Genentech, treatment in the early stages may stop the cancer before it spreads.
Recent medical innovations, especially immunotherapies, brought about improvements for some NSCLC patients yet no ALK inhibitors exist to treat ALK-positive disease in the early stages. About 5% of individuals with NSCLC have been found to be ALK-positive.
The ALINA Study (NCT03456076) Phase III
The ALINA randomized, open-label trial involves 257 patients with Stage IB ALK-positive NSCLC that have been completely resected (surgically removed). These patients are either assigned to the control arm or the investigational arm. The study evaluates the safety and efficacy of adjuvant Alecensa®, comparing it to platinum-based chemotherapy in these evaluable patients. Disease-free survival is the primary endpoint while the secondary measures are overall survival plus the number of patients who have experienced adverse events.
The American Cancer Society estimates that over 238,000 people living in the U.S. will receive a diagnosis of lung cancer with NSCLC affecting over 80% of lung cancer cases.
Early treatment has thus far provided the best chance of curing the disease.
About Alecensa®
This prescription medication is used for the treatment of NSCLC which is the result of an abnormal ALK gene that has spread (metastasized).
Before starting an Alecensa regimen, a physician will check the patient’s reaction to the medication. The safety of the drug for children has not yet been determined.
Safety Information
Severe side effects may occur that include hepatotoxicity (liver problems). This potential injury requires blood tests every two weeks for the first three months of treatment with Alecensa, then on an ‘as needed’ basis. Check the package instructions for other side effects.
Alecensa may cause severe kidney and lung problems, slow heartbeat, muscle pain, or affect red blood cells.
In addition to checking package directions have a thorough understanding of the medication’s potential side effects.
