The statistically significant and clinically meaningful improvement in disease-free survival is “practice-changing” and may represent a “paradigm shift” in treatment, according to experts.
Alectinib (Alecensa®; Roche) reduced risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared to platinum-based chemotherapy in patients with full resected stage 1B to 3A anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), according to results from the phase 3 ALINA study (NCT03456076) that will be presented in a late-breaking oral session at the European Society of Medical Oncology (ESMO) Congress 2023 Presidential Symposium.
“We urgently need to do more to help people with lung cancer, as about half of patients with early-stage NSCLC experience disease recurrence,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development, Roche, in a press release. “Alectinib can potentially alter the course of this disease as we aim to provide the best chance for cure.”
Alectinib is a highly selective, central nervous system (CNS)-active, oral medicine indicated to treat ALK-positive tumors. During the randomized, active-controlled, multicenter, open-label trial, investigators compared the efficacy and safety of alectinib to platinum-based chemotherapy in 257 patients with a fully resected stage 1B to 3A ALK-positive tumor.
The data showed alectinib had statistically significant and clinically meaningful improvement on the primary endpoint and disease-free survival (DFS), despite median DFS having not been evaluated yet. It also demonstrated a clinically meaningful improvement of CNS-DFS (HR=0.22; 95% CI: 0.08-0.58). Moreover, it is the first and only study that demonstrates an improvement in DFS in this patient population.
“The magnitude of DFS observed in this study could represent a paradigm shift in the way we manage early-stage ALK-positive lung cancer,” said Benjamin Solomon, medical oncologist, Peter MacCallum Cancer Centre, Australia, in the press release.
The study’s secondary endpoints are overall survival (OS) and percentage of patients with adverse events (AEs). According to the data, 30% of patients experienced grades 3 or 4 AEs with alectinib compared to 31% with chemotherapy. In addition, grade 5 AEs caused 5.5% of the alectinib arm and 12.5% of the chemotherapy arm to discontinue treatment, however the safety/tolerability remains consistent with data observed in previous studies of metastatic disease. Further, investigator report no new safety signals.
Lung cancer is one of the primary causes of cancer-related death around the world—nearly 2 million people die from lung cancer every year. The disease can be divided into 2 types, NSCLC and small-cell lung cancer (SCLC), with the former accounting for 85% of all lung cancer cases.
Unfortunately, as many as 76% of patients treated for early-stage disease will experience recurrence following surgery and adjuvant chemotherapy. Further, patients with ALK-positive mutations are at increased risk of developing brain metastases—once a patient has metastases, the disease may be considered incurable.
“These potentially practice-changing data reinforce the potential of alectinib as a new standard of care in the ALK-positive early lung cancer setting where treatment options are currently extremely limited,” Solomon said in the press release.
Roche’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer. Roche. News Release. October 18, 2023. Accessed on October 19, 2023.