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Merck KGaA, Pfizer discontinue late-stage study of Bavencio for ovarian cancer


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Merck KGaA, Pfizer discontinue late-stage study of Bavencio for ovarian cancer

Merck KGaA and Pfizer Inc. have discontinued the ongoing late-stage trial of Bavencio in certain patients with ovarian cancer.

The phase 3 study was halted in December 2018 based on interim results showing that Bavencio did not prolong the lives of women with ovarian cancer without the disease worsening.

Bavencio, or avelumab, belongs to a class of drugs called checkpoint inhibitors and works by targeting the PD-L1 protein, reducing the tumor's ability to escape the human body's cancer-killing T cells.

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The late-stage trial, named Javelin Ovarian PARP 100, was evaluating the efficacy and safety of Bavencio in combination with chemotherapy followed by maintenance therapy of Bavencio and Pfizer's PARP inhibitor Talzenna, or talazoparib, compared to chemotherapy alone in patients with locally advanced or metastatic ovarian cancer.

The companies decided to discontinue the trial for Bavencio based on the earlier results from the study along with factors such as the changing treatment landscape and the approval of a PARP inhibitor in the frontline maintenance setting.

Germany's Merck and New York's Pfizer were the first to test immunotherapy in this indication due to the significant unmet need in the treatment of ovarian cancer, according to a March 19 news release.

Bavencio also failed to extend the lives of patients with ovarian cancer that had returned or was resistant to platinum-based chemotherapy in another phase 3 trial called Javelin Ovarian 200.

The companies said the decision to discontinue the late-stage study will not impact the currently approved uses for Bavencio or the ongoing Javelin clinical development program.

Bavencio has been approved under the U.S. Food and Drug Administration's accelerated timeline for Merkel cell carcinoma, a rare and aggressive skin cancer, and bladder cancer after failed chemotherapy.