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Roche Immuno-oncology Drug Tecentriq Positive in Phase III

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Roche Holding AG (RHHBY - Free Report) announced positive results from a phase III study, OAK, on its immuno-oncology drug, Tecentriq.

Data from the study showed that treatment with Tecentriq led to a statistically significant and clinically meaningful improvement in overall survival (OS), compared to docetaxel chemotherapy in patients suffering from locally advanced or metastatic non-small cell lung cancer (NSCLC), whose disease progressed on or after treatment with platinum-based chemotherapy. Tecentriq also demonstrated a significant improvement in overall survival in patients regardless of their programmed death-ligand 1 (PD-L1) status.

The study met its co-primary endpoints. Roche will present full results at an upcoming medical meeting in 2016.

We remind investors Tecentriq enjoys Breakthrough Therapy Designation in the U.S. for the treatment of patients with PD-L1-positive NSCLC. On the other hand, Roche’s Biologics License Application (BLA) for Tecentriq for the treatment of NSCLC was granted priority review in the U.S. with an action date of Oct 19, 2016.

We note that Tecentriq obtained accelerated approval (based on tumor response rate and duration of response) from the FDA for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC).

Meanwhile, Roche currently has eight ongoing phase III studies on Tecentriq, alone or in combination with other treatments, in patients suffering from early and advanced stages of lung cancer.

Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. In recent times, immuno-oncology has become a key focus area for Roche and the company is making efforts to develop multiple candidates in this space. An approval of Tecentriq for NSCLC will boost the company’s immuno-oncology portfolio.

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , Corcept Therapeutics Incorporated (CORT - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).

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