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Pfizer's Bavencio Phase III Study for Ovarian Cancer Fails

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Pfizer, Inc. (PFE - Free Report) and partner Merck KGaA announced that a late-stage study, evaluating their PD-L1 inhibitor, Bavencio (avelumab), in a difficult-to-treat advanced ovarian cancer patient population failed to meet the primary endpoints of showing superior overall survival (OS) or progression-free survival (PFS).

The phase III JAVELIN Ovarian 200 study (n=566) compared avelumab alone or in combination with pegylated liposomal doxorubicin (PLD) — a type of chemotherapy — with PLD on patients suffering from this aggressive, refractory disease that had no response to prior platinum-based chemotherapy. This patient population has the biggest unmet need in advanced ovarian cancer. In the study, both PFS and OS fell short of reaching a statistical significance. However, the combo of avelumab and chemotherapy showed some potential clinical activity and the company confirmed the same to be tested further.

Other than JAVELIN Ovarian 200 study, avelumab+chemotherapy combination is being evaluated in two other late-stage studies in previously untreated ovarian cancer patients while another study is testing avelumab+chemotherapy followed by a maintenance treatment of avelumab + PARP inhibitor.

Shares of Pfizer have rallied 21.9% so far this year compared with the industry’s 8.2% increase.

 

 

Bavencio is marketed for metastatic Merkel cell carcinoma in the United States, Europe and Japan and for the second-line treatment of locally advanced or metastatic urothelial carcinoma, an aggressive disease with high rate of recurrence, in the United States. Though Bavencio is a relatively new drug in Pfizer’s oncology portfolio and is currently approved for two relatively smaller indications, it is being considered a key long-term growth driver for Pfizer if it can gain label expansion approvals.

The company is focusing on consistent growth and expansion of Bavencio into new indications and markets globally. Currently, Bavencio is being developed for more than 15 types of tumors including ovarian, breast, gastric/gastro-esophageal junction and head and neck cancers, melanoma, mesothelioma, Merkel cell carcinoma, non-small cell lung cancer, renal cell carcinoma and urothelial carcinoma. These studies are part of the JAVELIN development program.

Pfizer is also conducting avelumab double/triple combination studies for chemotherapy and targeted therapies and has several avelumab combination therapies with immuno-oncology agents under development.

Other PD-L1 inhibitors in the market are Merck’s (MRK - Free Report) Keytruda, Bristol Myers’ (BMY - Free Report) Opdivo, Roche’s Tecentriq and AstraZeneca’s (AZN - Free Report) Imfinzi.

Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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