Roche’s Alecensa Goes Up Against Zykadia with First-Line NSCLC US FDA Approval
Executive Summary
Expanded US approval for Alecensa in ALK-positive NSCLC will stand the product in good stead as it helps make up for upcoming biosimilar threat to Avastin, Rituxan and Herceptin.
The US FDA has approved an expanded indication for Roche’s second-generation anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib), which the company hopes will mean it can transform the standard of care for the treatment of people with ALK-positive metastatic non-small cell lung cancer (NSCLC). The drug is a key plank in the company’s defense against encroaching generic competition to its flagship products, Avastin (bevacizumab), Rituxan (rituximab) and Herceptin (trastuzumab).
The approval, based on the ALEX study, means it can be used upfront in patients with ALK-positive NSCLC as detected by an FDA-approved test. Alecensa had previously received breakthrough therapy designation for the treatment of adults with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.
The FDA has also converted Alecensa’s initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.
The approvals position Alecensa in the forefront of treatment for ALK-positive NSCLC. The ALEX studies showed that it gave significantly better progression-free survival among treatment-naive ALK-positive NSCLC patients compared with crizotinib (Pfizer Inc.’s Xalkori) – overall the median PFS for first-line patients was 25.7 months, compared with 10.4 months for the Pfizer drug.
The study also showed that Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared with crizotinib by 84% (p<0.0001). The full results were presented at the ESMO meeting in Madrid in September. (Also see "Brain Benefits Boost Roche's Alecensa In ALK Lung Cancer Race" - Scrip, 6 Sep, 2017.)
The data, plus further results from the ALUR study in hard to treat CNS metastatic NSCLC, give Alecensa the edge over its main rival, Novartis AG’s ALK-positive advanced NSCLC therapy Zykadia (ceritinib), for which there are some toxicity concerns. Moreover, while Zykadia can also cross the blood-brain barrier to act on CNS tumors, the study that led to its approval in the first-line setting compared it against chemotherapy rather than Xalkori. Alecensa’s head-to-head data against Xalkori are expected to be more persuasive to doctors and payers alike.
Analysts at Jefferies expect Alecensa to hit blockbuster sales by 2021.
The product has also just been filed for expanded approval in the EU. It was approved for second line use in February following a CHMP positive opinion in December last year. (Also see "Zykadia Challenged As Roche’s Alecensa Gets EU Nod" - Scrip, 16 Dec, 2016.)