US-based, biotechnology company Genentech has found during a phase III study of alecensa (alectinib) that the drug is better in treating people with advanced, ALK-positive, non-small cell lung cancer (NSCLC) compared to Crizotinib.
The trial undertaken on Japanese people with a specific type of lung cancer found that Alecensa, an oral anaplastic lymphoma kinase (ALK) inhibitor, cut down the risk of the disease worsening or death (progression-free survival, PFS) by 66% in comparison to crizotinib.
The trial was carried out on people who had not received prior treatment with an anaplastic lymphoma kinase (ALK) inhibitor.
Median PFS was not reached in people who received alecensa versus 10.2 months median PFS in people who received crizotinib.
The company said that there are fewer adverse events (AEs) in the alecensa arm compared with the crizotinib arm, while alecensa showed a safety profile consistent with that observed in previous studies with no new or unexpected AEs.
The most common AE found during the trial with alecensa was constipation, while the most common AEs for crizotinib were nausea, diarrhea, vomiting, visual disturbance, alteration in taste and constipation, as well as an elevation in liver enzymes called alanine transaminase and aspartate transaminase.
Conducted by Japanese-based drug manufacturer Chugai Pharmaceutical, the J-ALEX trial is an open-label, randomised Phase III trial that compared the efficacy and safety of alecensa to crizotinib in Japanese people.
The trial enrolled 207 people with ALK-positive, advanced and or recurrent NSCLC and randomised them to the alecensa group or the crizotinib group in a one-to-one ratio.
Alecensa received accelerated approval by the US Food and Drug Administration (FDA) in December last year to treat people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.
J-ALEX is a part of ALEX trial, a global, randomised, ongoing Phase III study comparing alecensa to crizotinib as an initial (first-line) treatment for people with advanced NSCLC, whose tumours were characterised as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.