Merck KGaA, Pfizer Accelerate Immuno-Oncology Drug Avelumab into Phase III Ovarian and Bladder Cancer Trials
December 22, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Darmstadt, Germany-based Merck KgaA and New York-based Pfizer, Inc. announced today that the two companies opened clinical trial sites for an international Phase III study of avelumab in platinum-resistant/refractory ovarian cancer. It is labeled JAVELIN Ovarian 200.
In addition, the companies are launching a Phase III study dubbed JAVELIN Bladder 100 that will study avelumab as a maintenance treatment in patients with locally advanced or metastatic urothelial cancer.
Avelumab is a fully human anti-PD-L1 IgG1 mono-clonal antibody. It falls clearly into the area of immuno-oncology therapeutics. The compound inhibits PD-L1 interactions, which appears to stimulate T-cells and the adaptive immune system. Merck KGaA (MRK) recently underwent a significant restructuring, and announced that Stefan Oschmann was the new chairman of the executive board and chief executive officer, replacing Karl-Ludwig Kley. In September, Merck KGaA announced it was streamlining its healthcare management, with the new Healthcare Executive Committee running the company.
And, of course, Pfizer (PFE) is merging with Dublin-based Allergan in a $160 billion deal.
Avelumab is also currently in a Phase III clinical trial for non-small cell lung cancer, and has been fast-tracked by the U.S. Food and Drug Administration (FDA) for Merkel cell carcinoma.
“There are limited treatment options for women with ovarian cancer, and the prognosis for women with platinum-resistant ovarian cancer is especially poor,” said Chris Boshoff, vice president and head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology, in a statement. “We have observed encouraging signs of early clinical activity of avelumab in patients with platinum-resistant or platinum-refractory ovarian cancer, and we hope to build on these results next year through a planned Phase III study of avelumab in combination with platinum therapy in patients with previously untreated ovarian cancer.”
The JAVELIN Ovarian 200 study will evaluate avelumab alone or in combination with pegylated liposomal doxorubicin (PLD) compared to PLD alone. The primary endpoint being evaluated is overall survival (OS). The companies plan to enroll about 550 patients at more than 190 locations in Asia, Europe and North America.
The JAVELIN Bladder 100 trial will study avelumab as a maintenance treatment in urothelial cancer. The companies indicate it is the only Phase III clinical study designed to evaluate an immunotherapy drug as a maintenance treatment in patients with urothelial cancer. It will compare the safety and efficacy of avelumab in addition to best supportive care (BSC) compared to BSC alone. Again, the primary endpoint is OS. Two patient populations will be studied, patients who are PD-L1 positive, and all randomized patients.
JAVELIN Bladder 100 is planned for 668 patients at more than 200 sites in 38 countries.
“Locally advanced or metastatic urothelial cancer is another aggressive cancer, with the disease often progressing quickly following first-line treatment,” said Alise Reicin, head of Global Clinical Development at Merck KGaA, in a statement. “It’s an exciting time for the Merck KGaA, Darmstadt, Germany, and Pfizer Alliance as we continue to accelerate our clinical development program, and now into urothelial cancer. This disease has an exceptionally high unmet need and we believe there is potential for our anti-PD-L1 antibody to be part of future treatment strategies.”