Alecensa’s revenue trends
In the first half of 2017, Roche’s (RHHBY) Alecensa generated revenues of CHF[1. Swiss franc] 148.0 million. In that period in the US and Japanese markets, Alecensa generated revenues of CHF 73.0 million and CHF 65.0 million, respectively.
Phase 3 ALUR trial
In September 2017, Roche presented the results of the Phase 3 ALUR trial, which was conducted to evaluate the safety and efficacy of Alecensa for the treatment of individuals with anaplastic lymphoma kinase (or ALK) positive advanced non-small cell lung cancer (or NSCLC) whose disease progressed after treatment with platinum-containing chemotherapy.
In the Phase 3 ALUR trial, patients on Alecensa therapy had median progression-free survival (or PFS) of 9.6 months compared to 1.4 months for patients on chemotherapy. Evaluation of PFS was the primary endpoint of the trial. The Phase 3 ALUR trial also demonstrated that patients on Alecensa had an overall response rate (or ORR) of 36.1% compared to 11.4% for patients on chemotherapy. Patients on Alecensa therapy demonstrated a disease control rate and median duration of response of 80.6% and 9.3 months, respectively, compared to 28.6% and 2.7 months, respectively, for patients on chemotherapy.
In August 2017, the FDA (U.S. Food & Drug Administration) accepted Roche’s sNDA (supplemental New Drug Application) for Alecensa as a first-line therapy for individuals with ALK-positive, locally advanced, or metastatic NSCLC. The sNDA was based on the results from the Phase 3 J-ALEX and Phase 3 ALEX trials. The FDA has granted the application a priority review designation.
In the Phase 3 ALEX trial, Alecensa demonstrated that it diminished the risk of death or disease worsening by 53.0% compared to crizotinib. In the Phase 3 J-ALEX trial, Alecensa showed a decrease in the risk of disease worsening or death by 62.0% compared to crizotinib. In the J-ALEX trial, patients on Alecensa had a median PFS of 25.9 months compared to 10.2 months for patients on crizotinib.
Roche’s peers in the NSCLC drugs market include Merck & Co. (MRK), Bristol-Myers Squibb (BMY), Eli Lilly, AstraZeneca, Pfizer (PFE), Novartis, and others. The Vanguard FTSE All-World ex-US ETF (VEU) invests ~0.73% of its total portfolio holdings in Roche Holding.