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Pfizer/Merck KGaA Start Two Phase III Studies on Avelumab

Pfizer Inc.PFE and Merck KGaA MKGAF announced that the trial sites have opened for an international phase III study (JAVELIN Ovarian 200) on their experimental anti-PD-L1 IgG1 monoclonal antibody, avelumab, in patients suffering from platinum-resistant/refractory ovarian cancer. The companies also announced that the first trial sites for a phase III study (JAVELIN Bladder 100) on avelumab for maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer are expected to open shortly.

The JAVELIN Ovarian 200 study is a randomized, open-label, parallel, multi-center study being conducted to evaluate the superiority of avelumab as a monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone for the treatment of patients with platinum-resistant/refractory ovarian cancer. The study is expected to enroll about 550 patients.

Meanwhile, a phase III study on avelumab in combination with platinum therapy in patients with previously untreated ovarian cancer is scheduled to commence next year.

On the other hand, the open-label, multi-center, randomized, JAVELIN Bladder 100 study (n= 668) will evaluate the safety and efficacy of avelumab plus best supportive care (BSC), compared with BSC alone, in patients with unresectable locally advanced or metastatic urothelial cancer whose disease did not progress on (or following) completion of first-line treatment with a platinum-containing chemotherapy.

The primary endpoint of both studies on avelumab is overall survival. We remind investors that in Nov 2014, Pfizer and Merck KGaA had announced a strategic alliance to co-develop and co-commercialize avelumab. Under the collaboration, six pivotal studies on avelumab have been initiated so far in 2015, with additional studies expected to commence in 2016.

Currently, avelumab is being developed for more than 15 types of tumors including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer.

The companies intend to commercially launch avelumab in 2017, provided the candidate is successfully developed and approved. Thereafter, they are targeting at least one additional potential launch per year through 2022.

Pfizer is a Zacks Rank #2 (Buy) stock. A couple of other favorably ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Anika Therapeutics Inc. ANIK . Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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