Genentech says the approval makes the drug the first ALK inhibitor for patients with ALK-positive, early-stage non-small cell lung cancer who have undergone surgery. 

RT’s Three Key Takeaways

  1. The approval was based on the phase III ALINA study, showing Alecensa reduced the risk of disease recurrence or death by 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC).
  2. This approval helps address an unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy.
  3. The National Comprehensive Cancer Network Guidelines recommend routine testing for ALK, EGFR, and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selection.

Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. 

The approval makes Alecensa the “first and only” ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor, according to a release from Genetech.

Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC. It has demonstrated significant efficacy in patients, including those with central nervous system metastases, and now with this approval, these benefits could extend to people with early-stage disease. 

“With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” says Levi Garraway, MD, PhD, chief medical officer and head of global product development, in a release. “At Genentech, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread.”

Study: Alecensa Cuts Recurrence by 76%

Genentech says the approval is based on positive results from the phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC. 

In an exploratory analysis, an improvement of central nervous system disease-free survival was observed. The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed. 

These data were presented as a late-breaking oral at the European Society of Medical Oncology Congress 2023 Presidential Symposium in October 2023 and were also recently published in the New England Journal of Medicine.

“The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy,” says Ken Culver, director of research and clinical affairs at ALK Positive, Inc, in a release. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC. Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”

Routine testing of resected surgical tissue or biopsy for ALK, EGFR, and PD-L1 biomarkers in patients with stage IB to IIIA and select IIIB NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, to support clinicians’ decision-making. About 5% of people with NSCLC are ALK-positive.

Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Data from the Phase III ALINA study will also be used for filing submissions to additional global health authorities, including the European Medicines Agency.

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