The FDA approved another inhibitor of anaplastic lymphoma kinase (ALK) for treatment of non-small cell lung cancer (NSCLC) today, further expanding precision treatment options. Alecensa (Alectinib) is indicated for advanced, metastatic, ALK-positive NSCLC in patients unresponsive to or intolerant of another ALK inhibitor, Xalkori (crizotinib).

The investigative agent, Alecensa, produces high anti-cancer responses among patients with NSCLC that have stopped responding to Xalkori and these results serve as the basis for the FDA approval. Alecensa trial results were recently published as a rapid online communication article in the Journal of Clinical Oncology.

Lung cancer remains the leading cause of cancer-related deaths in the United States. Non-small cell lung cancer is the most common type of lung cancer. NSCLC is further divided into different types of cancer, depending upon the types of cells from which the cancer originated, as well as to different biologic and genetic differences within the cells.

The continued identification of these differences in NSCLC has allowed researchers to exploit these individual characteristics and develop agents that are targeted against very specific variances in patients’ cancer cells.

The anaplastic lymphoma kinase (ALK) rearrangement refers to a type of NSCLC that has a mutation within the ALK-related genes. Agents targeted against these variances tend to produce significant anti-cancer responses among cancers that test positive for ALK rearrangements.

Xalkori is an agent already approved as treatment for NSCLC that tests positive ALK-rearrangements. Unfortunately, patients with ALK-positive NSCLC often have a cancer recurrence following treatment with Xalkori; therefore, researchers continue to evaluate novel therapeutic options for this group of patients.

Alecensa is an agent that is targeted against ALK rearrangements, and has recently completed evaluation in clinical trials for its safety and effectiveness.

Researchers recently conducted a clinical trial to further evaluate Alecensa among patients with NSCLC who had ALK rearrangements. The trial included 122 patients with ALK-positive NSCLC whose cancer had recurred following treatment with Xalkori.

  • Anti-cancer responses occurred in 50% of patients.
  • The median duration of anti-cancer responses was 11.2 months.
  • The median duration of survival without cancer progression was nearly 9 months.
  • Among patients whose cancer had spread to the central nervous system (CNS), stabilization or shrinkage of cancer within the CNS occurred in 83% of patients, with a median duration of CNS response being 10.3 months.
  • Common side effects associated with alectinib were constipation, fatigue, and swelling of the extremities, with most being mild.

The researchers concluded that “Alecensa is highly active and well tolerated in patients with advanced, crizotinib-refractory ALK-positive NSCLC, including those with CNS metastases.”

Reference: Ou SI, Ahn J, De Petris L, et al. Alectinib in crizotinib-refactory ALK-rearranged non-small cell lung cancer: A phase II global study. Journal of Clinical Oncology. Published online before print November 23, 2015, doi: 10.1200/JCO.2015.63.9443.

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