Merck KGaA, Pfizer begin 2 Phase III studies of cancer drug avelumab

German drugmaker Merck KGaA and American-based drug giant Pfizer recently initiated two new clinical trials involving the PD-L1 inhibitor known as avelumab. 

The first new trial, JAVELIN Ovarian 200, is a Phase III study determining the effectiveness of avelumab as a solo or combination treatment for individuals with platinum-resistant/refractory ovarian cancer. JAVELIN Ovarian 200 will enroll 550 subjects in more than 190 sites throughout North America, Europe and Asia.

"There are limited treatment options for women with ovarian cancer, and the prognosis for women with platinum-resistant ovarian cancer is especially poor,” Chris Boshoff, vice president and head of early development, translational and immune-oncology at Pfizer Oncology, said. "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 second new trial, JAVELIN Bladder 100, is a Phase III study evaluating avelumab as a  maintenance treatment for individuals with locally advanced or metastatic urothelial cancer whose condition didn't progress on or after first-line treatment featuring a platinum-containing chemotherapy. JAVELIN Bladder 100 will include more than 660 subjects in over 200 sites across 38 different countries.

“Locally advanced or metastatic urothelial cancer is another aggressive cancer, with the disease often progressing quickly following first-line treatment,” Merck KGaA Global Clinical Development Head Alise Reicin said. "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."

The two new trials result in a total of six avelumab studies launched by Merck KGaA and Pfizer over the past year.