OREANDA-NEWS. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 47% (HR=0.53, 95% CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by independent review committee (IRC). Median PFS was 25.7 months (95% CI: 19.9, not estimable) for people who received Alecensa compared with 10.4 months (95% CI: 7.7, 14.6) for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. 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 to crizotinib by 84% (HR=0.16, 95% CI: 0.10, 0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).1

“Our goal is to develop medicines that have the potential to significantly improve upon the standard of care,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain.”

Alecensa received Breakthrough Therapy Designation from the FDA in September 2016 for the treatment of adults with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. Results from the phase III ALEX study were simultaneously presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. Subsequently, Alecensa was recommended in the National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for first-line ALK-positive metastatic NSCLC (Category 1, Preferred).2

In addition to today’s approval, the FDA 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.

About the ALEX study1

ALEX (NCT02075840/B028984) is an open-label, randomised, active-controlled, multicentre, phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease and whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised (1:1) to receive either Alecensa or crizotinib. The major efficacy outcome measure of the ALEX study is PFS according to RECIST v1.1 as determined by investigator assessment. Additional efficacy outcome measures include: PFS as determined by IRC, time to CNS progression by IRC based on RECIST v1.1, objective response rate (ORR) and duration of response (DOR), and overall survival (OS). Additional exploratory outcome measures were CNS-ORR and CNS-DOR by IRC in people with measurable CNS metastases at baseline. The multicentre study was conducted in 303 people across 161 sites in 31 countries. OS data are currently considered immature with only about a quarter of events being reported. 

Results include:



Grade ≥ 3 adverse reactions were reported for 41% of patients treated with Alecensa. The most common Grade 3-4 adverse reactions (≥3%) were evidence of kidney dysfunction (increased creatinine; 4.1%), evidence of liver dysfunction (hyperbilirubinemia; 5%), low levels of sodium (hyponatremia; 6%), increased liver enzymes (aspartate transaminase; 6%, and alanine transaminase; 6%), and decreased red blood cells (anaemia; 7%). Serious adverse reactions reported in ≥2% of patients treated with Alecensa were lung infection (pneumonia; 4.6%) and renal impairment (3.9%).

About Alecensa

Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.1 It is almost always found in people with a specific type of NSCLC called adenocarcinoma.3

Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Liechtenstein, Thailand, United Arab Emirates, Saudi Arabia, Argentina and Turkey for the treatment of people with advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in Japan for people with ALK-positive NSCLC.