Bayer, a global chemical, pharmaceutical and life sciences company, has announced that their investigational drug BAY 94-9343 (anetumab ravtansine) did not meet its primary endpoint in a phase II clinical trial.
The company had hoped that the promising drug would offer a new option as a second line treatment for malignant pleural mesothelioma.
“The outcome of this phase 2 study with anetumab ravtansine in recurrent malignant pleural mesothelioma is disappointing, in particular for the patients suffering from this serious and extremely difficult to treat disease,” said Dr. Markus Enzelberger, Interim Chief Scientific Officer of MorphoSys AG, that partnered with Bayer in the trial, according to a July 21 press release.
The main purpose of the study was to assess efficacy and safety of anetumab ravtansine versus vinorelbine, a chemotherapy agent used in the treatment of lung cancer, in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).
The protein mesothelin is present in normal tissue, but certain types of malignant tumors, including mesothelioma, express high levels of mesothelin making it a primary target for anti-cancer drugs. In one study conducted by the University of Western Australia, researchers found elevated levels of soluble mesothelin-related protein or serum mesothelin in more than half of the mesothelioma patients at diagnosis.
The prognosis for mesothelioma patients is usually grim with an average survival time varying from 4 – 18 months after diagnosis. New treatment options are critical for improving survival and quality of life for mesothelioma sufferers.
For the nearly 3,000 Americans diagnosed with mesothelioma each year, clinical trials are critical to offering patients the opportunity to receive new, potentially more effective therapies. There are risks associated to clinical trials, however, the benefits often far outweigh the risks. As was the case with this trial, the risk may be that the experimental treatment may not be effective for the patients.
The “Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)” trial started on Dec. 3, 2015. There were 248 patients enrolled in the trial.
Find out more about the clinical trial at ClinicalTrials.gov.