FDA Approves Adjuvant Alectinib in ALK+ NSCLC

The FDA granted approval to alectinib (Alecensa) as an adjuvant treatment following tumor resection for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) whose tumors are at least 4 cm or node positive, as detected by an FDA-approved test.¹

Findings from the phase 3 ALINA trial (NCT03456076) support this regulatory decision as alectinib reduced the risk of disease recurrence or death by 76% vs platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive NSCLC (HR, 0.24; 95% CI, 0.13-0.43, P <.0001).

Additionally, at a median follow-up of 27.8 months for alectinib and 28.4 months for chemotherapy, the median disease-free survival (DFS) among the 116 patients in the alectinib arm was not yet reached (NR) compared with 44.4 months (95% CI, 27.8-not evaluable [NE]) for patients in the chemotherapy arm (n = 115).²

“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,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, in a press release.¹ “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. This approval brings us one step closer to achieving that mission.”

About the ALINA Trial in ALK-positive NSCLC

The randomized, active-controlled, multicenter, open-label ALINA study sought to assess the efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy in patients with resected stage IB to IIIA, ALK-positive NSCLC.

Patients were randomly assigned in a 1:1 fashion to receive 600 mg of alectinib twice per day for 2 years, or platinum-based chemotherapy every 3 weeks for 4 cycles. Chemotherapy regimens consisted of cisplatin plus pemetrexed, cisplatin plus vinorelbine, or cisplatin plus gemcitabine.

Enrollment was open to patients with an ECOG performance status of 0 to 1 who were eligible for platinum-based chemotherapy. Additional requirements included patients to have adequate end-organ function and have received no prior systemic cancer therapy.

The primary end point was investigator-assessed DFS, and key secondary end points were central nervous system DFS, overall survival, and safety.

REFERENCES:

1. FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer. News release. Genentech. April 18, 2024. Accessed April 18, 2024. https://tinyurl.com/5u9kkspr

2. Solomon BJ, Ahn JS, Dziadziuszko R, et al. ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patient with early-stage ALK+ non-small cell lung cancer (NSCLC). Ann Oncol. 2023;34(suppl 2):S1295-S1296. doi:10.1016/j.annonc.2023.10.051