Health Canada has approved Alecensaro (alectinib) to treat patients with a rare form of lung cancer. More specifically, the drug is approved as a first-line monotherapy for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).
Its approval was largely based on the phase 3 ALEX study showing the drug to be superior to Xalkori (crizotinib) in reducing the risk of disease progression and risk of cancer spreading to the brain.
In the ALEX study, published last year in the New England Journal of Medicine, 303 patients with previously untreated, advanced ALK-positive NSCLC were randomized to receive Alecensaro (600 mg twice daily) or Xalkori (250 mg twice daily). The primary end point was progression-free survival (PFS; investigator assessed). Secondary end points included time to CNS progression, objective response rate, and overall survival.
The study found that after 12 months, 68.4% of Alecensaro treated patients has not shown any disease progression compared to only 48.7% of Xalkori treated patients. In addition, only 12% of patients in the Alecensaro group showed signs of the disease metastasizing to the brain compared to 45% of those given Xalkori.
In a news release, clinicians and advocates were excited about the approval as the drug can significantly reduce the time to disease progression and metastasizing to the brain.
Randeep Sangha, MD, medical oncologist at Cross Cancer Institute said, “This treatment also meets a significant unmet need by reducing the risk of CNS progression, which is important for patients as the growth or spread of tumours in the CNS is often associated with a poor prognosis.”
Shem Singh, Executive Director at Lung Cancer Canada added, “Current treatments for brain metastases, such as whole brain radiation, have the potential to leave a patient with permanent cognitive impairments. Oral treatments that both decrease the risk of tumours spreading to the brain and work on tumours that have already spread there means that patients can spend less time in the hospital, have fewer serious side effects and spend more quality time with family and friends.”
Delores Zuk, a patient with ALK-positive NSCLC noted, “Knowing that there is a medication targeted to my specific disease helps me face each day with a more positive attitude, with the hope that there are more days ahead of me.”
While the drug has been approved by Health Canada, it still needs to be assessed by the pan-Canadian Oncology Drug Review (pCODR) and the provincial ministries to enter the public drug plans. Given the very impressive efficacy the drug has shown, it is hopeful the drug will be available soon.
Peters S, Camidge R, Shaw AT et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer. New England J Med, 2017; 377:829-838. http://www.nejm.org/doi/full/10.1056/NEJMoa1704795.