In a statement released on Sunday, Bayer announced that Anetumab ravtansine, its antibody-drug conjugate (ADC) tested in mesothelioma, has missed its primary endpoint failing to improve progression-free survival in mesothelioma patients.
“Malignant pleural mesothelioma is a very difficult-to-treat tumor, and we had hoped for a better outcome for patients,” said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. “We would like to thank the patients and their caregivers, as well as the study investigators for their participation and contributions in this study. Based on the available data, we remain committed to further evaluating the utility and safety of anetumab ravtansine across multiple tumor types with significant unmet medical need.”
“We are very disappointed about this outcome most especially as it affects our patients,” said Melinda Kotzian, the chief executive officer of the Mesothelioma Applied Research Foundation. “Despite this setback, patients must keep in mind that there are currently more than 35 other clinical trials in process in the United States alone, and should call us if they need more information.”
The phase II clinical trial (NCT02610140) is a randomized, open-label, active-controlled, multicenter superiority study investigating anetumab ravtansine as second line treatment in patients with advanced or metastatic mesothelin-positive malignant pleural mesothelioma (MPM), whose disease had progressed after treatment with first-line platinum/pemetrexed-based chemotherapy. The trial randomized 248 patients in a 2:1 ratio to receive either anetumab ravtansine (6.5 mg/kg intravenously every three weeks) or vinorelbine (30 mg/m2 intravenously every week).
More detailed data about the trial will be released fully at an upcoming medical meeting.