Pfizer/Merck KGaA End Bavencio Ovarian Cancer Phase III Study
Pfizer, Inc. PFE and partner Merck KGaA announced that a late-stage study evaluating its PD-L1 inhibitor, Bavencio for first-line ovarian cancer is being discontinued.
The phase III JAVELIN Ovarian 100 study (n=998) evaluated Bavencio (avelumab) in combination with and/or following platinum-based chemotherapy in previously untreated patients with advanced ovarian cancer.
Data from a planned interim analysis showed that the study will not achieve superiority in the pre-specified primary endpoint of progression-free survival (PFS). Pfizer said the decision to end the study was in alignment with the independent Data Monitoring Committee.
This is the second avelumab ovarian cancer study failure for Pfizer/Merck KGaA in less than two months. In November, a late-stage study, evaluating avelumab + chemotherapy in a difficult-to-treat advanced ovarian cancer patient population failed to meet the primary endpoints of showing superior overall survival (OS) and PFS.
Meanwhile, the avelumab+chemotherapy combination is being evaluated in another late-stage study, which is testing avelumab+chemotherapy followed by a maintenance treatment of avelumab + PARP inhibitor. This study and other earlier phase studies on avelumab in various combinations are continuing.
Shares of Pfizer have rallied 15.7% so far this year compared with the industry’s 1.1% 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 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. 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.
However, several other studies on Bavencio have failed in the past. In February, a late-stage study evaluating avelumab monotherapy in advanced non-small cell lung cancer patients who were previously treated with platinum-containing doublet therapy, failed to meet the primary endpoint of OS. Last year a late-stage study evaluating avelumab for the treatment of gastric cancer in the third-line setting also failed to meet the primary endpoint.
Failures like these significantly hurt the drug’s prospects as it competes with successful PD-L1 inhibitors in the market like Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo and Roche’s RHHBY Tecentriq.
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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