The phase III, multicenter, open-label, randomized three-arm study was conducted to evaluate the safety and efficacy profile of Gazyva in combination with chlorambucil compared to MabThera in combination with chlorambucil or chlorambucil alone, in nearly 800 patients with previously untreated CLL and comorbidities.
The final results, after a follow-up of almost five years, showed clinically meaningful improvements with Gazyva plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with Rituxan plus chlorambucil.
These long-term data confirm Gazyva’s efficacy to extend the lives of patients suffering from CLL, compared to that of MabThera/Rituxan.
Gazyva-based treatment reduced the risk of death by 24% compared to MabThera/Rituxan-based treatment. Gazyva is approved in combination with chlorambucil, for patients with previously untreated CLL.
Roche is a leader in the oncology market with a wide portfolio of drugs for breast cancer and CLL among others.
Additionally, Roche announced new data on multiple sclerosis (MS) drug, Ocrevus, which will be presented at the 4th Congress of the European Academy of Neurology (EAN) from Jun 16-19 in Lisbon, Portugal.
The data from a new exploratory analysis, from the extended control period of the phase III study, ORATORIO, in primary progressive multiple sclerosis (PPMS) patients, showed that Ocrevus may significantly delay the time to need a wheelchair by seven years, as measured by the length of time until a person reaches Expanded Disability Status Scale seven or greater (EDSS≥7), using 24-week confirmed disability progression (CDP).
Patients, treated with Ocrevus, showed a 46% reduction in the risk of progressing to a wheelchair compared to the placebo-treated group. The analysis also showed that the placebo-treated patient population studied in Oratorio had similar disability progression rates to an untreated real-world PPMS population. The extrapolated median time to wheelchair (EDSS≥7) for placebo-treated people in the Oratorio study was 12.1 years.
The longer-term efficacy and safety data are consistent with the drug’s favourable benefit-risk profile, for both PPMS and relapsing MS (RMS).
In addition, a new global study, FLOODLIGHT Open, is now enrolling patients in the United States. The study uses proprietary FLOODLIGHT mobile technology to collect and monitor anonymized patient data to help gain a better understanding of MS disease progression. The study is an observational, open access study aimed to enroll 10,000 people globally, including people with relapsing and progressive forms of MS, within five years.
Roche will be initiating two new phase IIIb studies of Ocrevus in 2018.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche, as its legacy drugs like Herceptin and MabThera are facing competition from biosimilars.
Roche’s stock has lost 12.7% in the last six months compared with industry’s’ decline of 3.1%.
Novartis (NVS – Free Report) has already launched its biosimilar version of Rituxan in Europe. Amgen (AMGN – Free Report) has also obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.