Germany's Merck KGaA and New York's Pfizer Inc. have halted a late-stage trial of their drug Bavencio in patients with ovarian cancer because results of an interim analysis did not support the study's goals.
Results from the unfinished study, called Javelin Ovarian 100, showed that Bavencio, an immuno-oncology drug designed to block receptors on the cancer cell that allow it to evade the immune system, did not prolong the lives of women with ovarian cancer without the disease worsening.
The 998 patients in the study with advanced or spreading ovarian cancer received chemotherapy in addition to Bavencio, otherwise known as avelumab, or had received chemotherapy beforehand. The study compared the regimen with chemotherapy alone.
The safety profile was consistent with other trials in the Javelin development program.
Merck and Pfizer were the first to test an immunotherapy in this indication.
This is the second phase 3 trial featuring Bavencio in just over a month in which the companies have seen disappointing results, the first having failed in November to extend patients' lives with ovarian cancer that had returned or was resistant to platinum-based chemotherapy, called Javelin Ovarian 200.
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.