FDA approves alectinib for ALK+ NSCLC

The good news

The FDA recently approved alectinib as adjuvant treatment for patients after surgical removal of early stage (IB-IIIA) anaplastic lymphoma kinase – positive (ALK+) non-small cell lung cancer (NSCLC).

Why it’s important

ALK rearrangements occur in approximately 5% of patients with NSCLC. Adjuvant treatment is therapy given after surgery to prevent the cancer from returning. Despite the development of targeted therapy specific for ALK+ NSCLC, chemotherapy was the recommended adjuvant treatment for patients after surgery. The Alina trial was a Phase 3 clinical study in which 257 patients with early stage ALK+ NSCLC received alectinib (an oral therapy for ALK+ cancer) or chemotherapy after surgery¹. The results showed that 93.8% of the patients in the alectinib group were alive and free of cancer at 2 years compared to 63% of the patients who received chemotherapy alone. The brain is a common site of metastases after surgery and alectinib was also able to significantly control the spread of disease to the brain. alectinib was well tolerated with no new safety concerns.

What it means for patients

This is the first targeted therapy approved for use after surgery for ALK+ lung cancer without the need for chemotherapy. This is an important advancement because it allows patients to be treated with a therapy that specifically targets ALK without the added side effects of chemotherapy. The results are early so it will be a while before it is known whether patients live longer because of the treatment. Patients were treated for 2 years with alectinib, so another outstanding question has to do with the optimal length of treatment. This trial also brings up the importance of molecular testing of lung cancer even when it presents at an early stage.

What to watch for

There will be updates on the results of the Alina trial over the next few years. There will also likely be attempts at answering outstanding questions such as how long to treat patients. Look for adjuvant trials that will evaluate targeted treatment in other types of lung cancer. There is also an interest in evaluating targeted therapy before surgery is done. This approach is called neoadjuvant treatment. Clinical trials are ongoing in this area.

¹ New England Journal of Medicine, Volume 390, pages 1265-1276, 2024