- Pfizer and Germany-based Merck KGaA have jointly launched a late-stage combination trial evaluating the developmental checkpoint inhibitor avelumab as a first-line treatment for ovarian cancer, the companies said Wednesday.
- Notably, the study will combine avelumab with platinum-based chemotherapy, the first such Phase 3 trial to evaluate a checkpoint inhibitor with standard of care in a first-line setting for the aggressive cancer.
- The companies are already studying avelumab on its own as a treatment option for refractory ovarian cancer as part of their broad development program for the checkpoint inhibitor.
Pfizer has yet to catch up with its peers in the race to develop a immuno-oncology drug, but the company's strategic partnership with German Merck aims to fix that deficit.
Pfizer paid $850 million upfront in late 2014 to partner with Merck KGaA on avelumab, with roughly $2 billion in potential milestones. The alliance is testing the drug across over 15 tumor types and has enrolled about 2,200 patients in various trials.
The newly announced Phase 3 trial will enroll 950 women with untreated Stage 3 or 4 ovarian cancer. Participants will be split into three treatment arms which will test avelumab concurrent with chemo, avelumab following chemo, and chemo alone.
Ovarian cancer is a particularly aggressive and hard-to-treat disease.
While Pfizer is late to the immuno-oncology game, the avelumab trials certainly aren't lacking in breadth of investment. Merck and Bristol-Myers Squibb are currently the early leaders with their drugs Keytruda and Opdivo, but the recent approval of Roche's Tecentriq has broadened the field.
Pfizer and Merck KGaA hope their unique combination of avelumab with standard-of-care will help them leapfrog the competition.
"The hope is that avelumab can change the natural history of the disease and potentially take the survival rate beyond the current five year estimate," said Alise Reicin, head of global clinical development at Merck KGaA.