Pfizer, German Merck start first-ever PhIII PD-L1 combo trial for ovarian cancer

Merck kgaa HQ

Pfizer ($PFE) and research partner Merck KGaA have begun late-stage testing of their experimental checkpoint inhibitor avelumab with chemo in certain ovarian cancer patients.

The partners will use avelumab, a PD-L1 checkpoint inhibitor, together with a platinum-based chemotherapy (or also used as a maintenance therapy) in a Phase III trial for women with late-stage, previously untreated epithelial ovarian cancer.

Pfizer and German-based Merck note that this is the first time such a trial has been undertaken--i.e., the use of a checkpoint inhibitor with standard of care in this patient population.

The open-label test will look at two first-line therapies with avelumab and platinum-based chemotherapy and compare it to a platinum-based chemotherapy alone, with the main endpoint being progression-free survival.

“Patients with ovarian cancer need additional treatment options,” said Dr. Chris Boshoff, head of early development, translational and immuno-oncology at Pfizer, in a statement. "We believe there could be synergistic activity in the combination of avelumab and established treatments such as platinum-based chemotherapy. With two studies now underway of avelumab in ovarian cancer, we look forward to receiving the results from these trials and continuing to break ground in this hard-to-treat cancer.”

Ovarian cancer can have poor outcomes, especially in the later stages, but some new drugs have come to the market in recent years, including a new indication for Roche’s ($RHHBY) Avastin (bevacizumab), in combination with chemotherapy, for women with platinum-resistant, recurrent ovarian cancer.

AstraZeneca ($AZN) also markets its PARP inhibitor Lynparza (olaparib) for women with advanced ovarian cancer associated with defective BRCA genes. Roche is seen as being able to add around $1 billion to its Avastin franchise with the indication, while AZ is set for $2 billion in peak sales.

The Anglo-Swedish Big Pharma also announced this year that its biologics arm MedImmune and Jacksonville, FL-based biotech TapImmune have begun a midstage trial of the cancer vaccine TPIV 200--a multiepitope antifolate receptor vaccine (FRα)--in combination with Astra’s PD-L1 drug candidate durvalumab, in patients with platinum-resistant ovarian cancer.

Pfizer, which has lagged behind its Big Pharma rivals Bristol-Myers Squibb ($BMY), Merck ($MRK) and now Roche in this therapy class, signed an $850 million deal with Germany’s Merck back in 2014 to gain access to its PD-L1 program.

As with its rivals, the two are also testing the drug in a host of other cancers, as well as joining them up with other meds from Pfizer’s pipeline and portfolio to see if a cocktail therapy can extend patients’ lives.

- check out the release

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