Roche’s Alecensa smashes phase 3 as adjuvant therapy for lung cancer

Lung cancer is one of the leading causes​ of cancer deaths globally, with NSCLC being one of the most common forms of the disease. Additionally, many early lung cancer cases recur after surgery, despite modern treatment approaches including adjuvant chemotherapy and immunotherapy.

Alecensa is a small molecule drug designed to block variations of the protein anaplastic lymphoma kinase (ALK), which occur in around 5% of NSCLC cases​. The drug is already approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for ALK-positive, metastatic NSCLC. Roche is aiming to develop the drug in earlier stages of the disease as an adjuvant therapy following surgical removal of the tumor.

In the trial, dubbed ALINA, Alecensa was compared with platinum-based chemotherapy in 257 patients with resected ALK-positive NSCLC. According to a pre-planned interim analysis, Alecensa’s improvement in disease-free survival met the trial’s primary endpoint, though the overall survival results were not ready to call. Roche also found no unexpected safety findings in the trial.

“Alecensa 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 Roche’s chief medical officer and head of global product development, Levi Garraway, in a public statement.

“If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure, which is our ultimate goal at Roche. We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”

Alecensa is one of several ALK inhibitors​ in the cancer treatment market. The first to be approved by the FDA for metastatic NSCLC was crizotinib in 2011. And other ALK inhibitors such as Pfizer's lorlatinib and Betta Pharmaceuticals’ ensartinib have emerged since Alecensa was first approved in 2015. If its development as an adjuvant proceeds to plan, Alecensa could become the first approved ALK inhibitor for early-stage ALK-positive lung cancer.

While ALK inhibitors can be effective treatments for NSCLC, the cancer can develop resistance to these drugs​. This is leading to the development of treatment combinations with other therapies to prevent resistance. For example, Alecensa showed promise​ in combination with the antibody drug bevacizumab in a phase 2 trial in patients with advanced ALK-positive NSCLC.