- West coast biotech Exelixis has entered two new partnerships to test its cancer medication in combination with Bristol-Myers Squibb and Roche's competing checkpoint inhibitors.
- Exelixis is pairing its drug Cabometyx (cabozantinib) with Bristol-Myers' Opdivo (nivolumab) in a late-stage, pivotal study of patients with first-line renal cell carcinoma, as well as with Roche's Tecentriq (atezolizumab) in a Phase 1b, dose escalation trial of patients with locally advanced or metastatic solid tumors.
- Those initial trials are also serving as the springboard for additional investigations. Exelixis and Bristol-Myers expect to initiate other trials testing their combo therapy in a variety of cancers, including bladder and liver. Meanwhile, a positive readout from the Phase 1b trial would support testing in other patient populations for diseases such as advanced kidney cancer and urothelial carcinoma.
The deals come as no surprise given how combination therapies are on the rise inthe immuno-oncology space, particularly among checkpoint inhibitor drugs. Bristol-Myers, Roche and Merck & Co, are the three heavyweights in that class, and have made it clear in recent months their intent to lock down more collaborations.
While combo therapies will be key for all those players, Bristol-Myers has arguably the most to prove. Opdivo's clinical failure as a first-line treatment for patients with non-small cell lung cancer last year has haunted its parent ever since, placing doubts the company can stay ahead of Keytruda and even contributing to rumors of a potential takeover.
Bristol-Myers has been a long time partner of Exelixis. This newest collaboration follows positive Phase 1 results revealed in October demonstrating the Opdivo and Cabometyx combination therapy had a 43% objective response rate in previously treated genitourinary tumor patients. Results from a second part of that study, which evaluated a three-drug combination that also included Bristol-Myers' Yervoy (ipilimumab). Combined, the two parts had less than 40 patients enrolled.
Exelixis and Bristol-Myers will split the cost of developing the combination and putting it through Phase 3 testing. In the Roche partnership, the big pharma will provide Tecentriq while Exelixis pays for the other clinical expenses. Enrollment for that trial is slated to begin in mid-2017.
"Although several therapies have recently received regulatory approval to treat advanced kidney and bladder cancers, survival continues largely to be measured in months, not years," Exelixis CEO Michael Morrissey said of the Roche partnership. "Evaluating how cabozantinib may positively impact treatment when paired with immunotherapy is central to our goal of improving therapeutic outcomes for patients with these and other cancers.”