Seeking a boost over Opdivo's efficacy in non-small cell lung cancer, Bristol-Myers Squibb and Bavarian Nordic have kicked off testing the Big Pharma's checkpoint inhibitor in conjunction with the biotech's cancer vaccine CV301.
The partners are starting with a phase 1 safety trial that will enroll up to 40 non-small cell lung cancer patients who have failed on previous treatments, the companies said. The phase 2 follow-up will include 120 patients and test the combo versus Opdivo alone.
“[T]his study is the first seeking proof-of-concept for a promising combination approach, and we look forward to the results, as well as to advance CV301 as combination therapy in additional indications over the next years,” Paul Chaplin, president and CEO of Bavarian Nordic, said in a statement.
The idea is that the vaccine will generate a tumor T-cell response, and Opdivo will prevent the tumor from hampering that response. Opdivo is FDA-approved as a second-line monotherapy in NSCLC, but the companies are hoping the combo can pump up the solo med's cancer-fighting prowess.
The Danish biotech is focusing on developing its vaccine in combination with checkpoint inhibitors, not only in patients with non-small cell lung cancer, but also those with bladder cancer and colorectal cancer. While overall survival rate is the primary endpoint for this particular phase 2 study, investigators will also look at secondary endpoints including response rate.
For Bristol-Myers, the Bavarian Nordic trials add to the company's growing list of combination approaches centered on Opdivo. After a clinical trial fiasco for Opdivo in newly diagnosed lung cancer—an indication that could have brought in billions in sales—Bristol-Myers has said it's counting on combo treatments and new indications to continue expanding the drug's market.
It's not the first time BMS and Bavarian Nordic have kicked off a cancer vaccine/checkpoint inhibitor trial. About two months ago, they started a phase 2 study testing BMS’ Yervoy, a CTLA-4 checkpoint inhibitor, in combination with BN’s vaccine Prostvac in prostate cancer. Bristol-Myers has an option on Prostvac under a deal struck back in 2015.
If that product is successful, it could be worth $1 billion for BN. The partners plan to add Opdivo, which inhibits the PD-1 pathway, to the Yervoy-Prostvac combo in future trials.