It took a significantly longer time for non-small lung cancer patients who received Roche’s Alecensa (alectinib) to have their disease progress than those who received chemotherapy, according to a Phase 3 clinical trial.
The results applied to ALK-positive non-small cell lung cancer (NSCLC) patients whose disease progressed after they were treated with platinum-based chemotherapy and Xalkori (crizotinib). The findings mean that the Phase 3 ALUR trial met its primary effectiveness objective.
“We are pleased to announce that the results of the phase III ALUR trial further support the use of Alecensa as a treatment for people with ALK-positive lung cancer who, after having progressed on both chemotherapy and crizotinib, are in need of new treatment options,” Sandra Horning, MD, Roche’s chief medical officer, said in a press release. “The results of this trial will support our access discussions with global health authorities as we seek to bring Alecensa to patients faster.”
The trial (NCT02604342) randomized 119 patients with ALK-positive NSCLC to receive either Alecensa, a selective ALK inhibitor, or one of two platinum-based chemotherapies: Alimta (pemetrexed) or docetaxel. The trial participants had already received a line of platinum-based chemotherapy and Xalkori (crizotinib), another ALK inhibitor.
The primary objective of the trial was better progression-free survival in patients who took Alecensa than in patients who received chemotherapy.
One of the secondary measurements was overall patient survival. Another was median time before the cancer spread to the brain. And a third was the objective response rate of patients whose cancer had already reached the brain before their treatment started. Objective response rate is either a complete or partial response to a treatment.
The U.S. Food and Drug Administration approved Alecensa, which was developed by Japan’s Chugai Pharmaceutical, in December 2015 for certain patients: people with advanced ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, Xalkori.
Japan has approved Alecensa for patients with tumors that are advanced, have returned or could not be removed completely with surgery. The drug is also approved in Switzerland, Canada, Israel, Hong Kong, South Korea, India, and Kuwait.
The European Commission has conditionally authorized F. Hoffmann-La Roche to market Alecensa to treat patients with ALK-positive, metastatic non-small cell lung cancer (NSCLC) who are unable to tolerate Xalkori or whose disease progressed while they received it.
This European approval was based on results of the Phase 1/2 NP28761 (NCT01871805) and NP28673 (NCT01801111) clinical trials. Alecensa improved patients’ progression-free survival by 8.9 months in the first trial and 8.2 months in the second.
A combined analysis of the two studies showed that Alecensa shrank central nervous system tumors in 64 percent of the patients.
Another Phase 3 study, ALEX (NCT02075840), is comparing the effectiveness and safety of Alecensa versus Xalkori as a first-line treatment for patients with advanced ALK-positive NSCLC. Results should be available in coming months.
About 75,000 people around the world are diagnosed with ALK-positive NSCLC each year. The patients’ chromosomes have been rearranged so that their ALK gene fuses with another gene. That leads to the generation of tumor cells.