Phase 3 Trial Results Show Adjuvant Alectinib May Reduce Recurrence in Early-Stage ALK-Positive NSCLC


If approved, alectinib would be the only anaplastic lymphoma kinase inhibitor to show reductions in risk of recurrence or death for those with early-stage lung cancer.

The phase 3 ALINA study (NCT03456076) evaluating adjuvant alectinib (Alecensa; Roche) against an adjuvant platinum-based chemotherapy met its projected goal of disease-free survival (DFS) at a prespecified interim analysis point, according to study investigators. Compared to adjuvant platinum-based chemotherapy, alectinib showed a statistically significant and clinically meaningful improvement in DFS in people with resected stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

3D rendered image of human lungs with tumor

Image credit: SciePro |

Alectinib is a highly selective, central nervous system-active, oral medicine used to treat NSCLC among patients with tumors identified as ALK-positive. Currently, alectinib is approved in over 100 countries as a first-line treatment for ALK-positive, metastatic NSCLC.

The randomized, active-controlled, multicenter, open-label ALINA study consisted of 257 patients who were randomly assigned to either the investigational group or the control treatment group. Every patient had completely resected stage IB to IIIA ALK-positive NSCLC and had received either alectinib or platinum-based chemotherapy. The trial evaluated the efficacy and safety of alectinib, rates of DFS, and measures of overall survival (OS), as well as the percentage of patients with adverse events (AEs); however, the OS data were immature at the time of this trial readout.

“[Alectinib] has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release.

Although there have been recent breakthroughs in treatment (eg, immunotherapies) that have improved outlooks for patients with early-stage NSCLC, there are no approved ALK inhibitors for early-stage ALK-positive disease. According to the study authors, approximately 5% of people with NSCLC are ALK-positive, with the disease often found in younger people aged 55 years and younger who have a light- or non-smoking history.

According to prior data, lung cancer is one of the leading causes of cancer death globally, with approximately 1.8 million annual deaths. Lung cancer is typically divided into 2 major types, NSCLC and small-cell lung cancer, with NSCLC being the most prevalent type. Roche estimates that about half of patients with early lung cancer (45%-76%, depending on disease’s stage) continue to experience cancer recurrence following surgery, despite receiving adjuvant chemotherapy. Treating lung cancer early—before it has spread—can provide patients with the strongest chance of curing the disease and preventing it from recurring.

Following these study results, investigators plan to present the data at an upcoming medical meeting and submit the data to health authorities, including FDA and the European Medicines Agency.

“If approved, [alectinib] has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Garraway said in the press release. “We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”


Roche. Roche’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer. New release. September 1, 2023. Accessed September 5, 2023.

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