- Bristol-Myers Squibb and Clovis Oncology are putting together their flagship cancer agents in a trio of mid- to late-stage studies that will evaluate the drug combination in several types of tumors.
- Per an agreement announced Monday, the companies will investigate Bristol-Myers' Opdivo paired with Clovis' Rubraca in two pivotal Phase 3 trials focused on advanced ovarian cancer and advanced triple-negative breast cancer. Another Phase 2 trial will assess the combination in patients with metastatic castration-resistant prostate cancer (mCRPC).
- The companies plan to start the late-stage studies before the end of 2017, whereas the mCRPC investigation will be one arm of a "larger Bristol-Myers Sqibb-sponsored study," according to a July 31 statement. Financial terms of the deal were not disclosed.
The Bristol-Myers and Clovis deal reflects two broader themes seen across the cancer drug making space: investment in combination therapies and a blossoming interest in PARP inhibitors.
Those trends were perhaps most evident last week, when, on the heels of a massive clinical setback with its anti-PD-L1 inhibitor Imfinzi (durvalumab), AstraZeneca locked down an $8.5 billion deal with Merck aimed, in part, at developing and commercializing combo treatments that include the British pharma's anti-PARP treatment Lynparza (olaparib).
Notably, the companies plan to evaluate Lynparza paired with anti-PD-1 drugs — either Imfinzi or Merck's Keytruda (pembrolizumab). While Bristol-Myers and Clovis didn't reveal the value or cost-sharing structure of their clinical collaboration, it's clear big pharma is willing to put big bucks behind PARP combination therapies.
Already, PD-L1 and PARP inhibitors have separately shown their benefit to bottom lines. Opdivo, for instance, fetched Bristol-Myers Squibb nearly $1.2 billion during the second quarter, according to the company's latest 10-Q filing with the Securities and Exchange Commission. Lynparza, meanwhile, brought in $57 million for AstraZeneca during the first quarter.
Success with a combination of Opdivo (nivolumab) and Rubraca (rucaparib) could help Bristol-Myers better compete with its many rivals in immuno-oncology, while a pairing with Opdivo could give Clovis a tailwind behind Rubraca.
Rubraca received approval in December as a treatment for advanced ovarian cancer patients whose tumors have the deleterious BRCA gene mutation and who have previously received two or more types of chemotherapy. Having only been on the market for about three months, the Clovis drug brought in about $7 million in net product revenue.
"We are very enthusiastic about studying Rubraca and Opdivo in combination, and the potential to create new treatment options for patients with multiple tumor types, as well as for patients beyond those with BRCA mutations," Clovis CEO Patrick Mahaffy said in the July 31 statement. "This substantial clinical collaboration in ovarian, triple-negative breast and prostate cancers represents a significant effort by Clovis and Bristol-Myers Squibb to realize that potential."