Roche Holding AG (RHHBY - Free Report) announced positive results from a phase III study, IMmotion 151 on immuno-oncology drug Tecentriq.
The study evaluated the efficacy and safety of Tecentriq and Avastin versus Sutent in renal cell carcinoma patients.
The study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) and demonstrated that the combination of Tecentriq and Avastin provided a statistically significant and clinically meaningful reduction of disease worsening or death (PFS) in patients with PD-L1 protein compared with Sutent for first-line treatment of patients suffering from advanced or metastatic renal cell carcinoma.
Top-line results from the co-primary endpoint of overall survival are not mature.
IMmotion151 is the second successive positive phase III study of Tecentriq that includes an Avastin combination component as an initial treatment. The study followed the positive phase III non-squamous non-small cell lung cancer (NSCLC) IMpower150 study that revealed that Tecentriq and Avastin plus chemotherapy had a PFS advantage over Avastin plus chemotherapy.
We note that Tecentriq is already approved in the European Union, United States for previously treated metastatic NSCLC and metastatic urothelial cancer.
So far this year, shares of the company have moved up 12.3% compared with the industry’s gain of 20.4%.
In addition, Roche announced positive results from the randomised phase II GO29365 study that compared polatuzumab vedotin in combination with bendamustine plus MabThera/Rituxan (BR) against BR alone in patients suffering from relapsed or refractory diffuse large B-cell lymphoma who are not candidates for haematopoietic stem cell transplant.
The study met its primary endpoint, demonstrating that the addition of polatuzumab vedotin to BR increased complete response rates from 15-40% (p=0.012) at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin, MabThera are already facing competition from biosimilars.
Novartis AG NVS has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) and its partner Allergan (AGN - Free Report) have 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. The biosimilar to be marketed by the trade name Mvasi is the first cancer biosimilar approved in the United States.
Roche currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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