Bavarian and BMS press on with Opdivo and cancer vaccine combo

After a major setback to its previously unstoppable Opdivo, Bristol-Myers Squibb is to work with biotech Bavarian Nordic on new combination trials.

Danish vaccine specialists Bavarian Nordic is to lead the trial combining Opdivo (nivolumab) with its cancer immunotherapy vaccine CV301.

The company is to enrol around 160 patients in a trial to investigate their use together in previously treated non-small cell lung cancer (NSCLC)

Investors were stunned less than two weeks ago when BMS announced that Opdivo had failed to show benefit in advanced NSCLC as a first line monotherapy – news which took everybody by surprise, and dented the image of a drug which has become the clear leader in cancer immunotherapy.

The surprising result is at least partly attributed to the fact that BMS tried to broaden out treatment to patients with a low PD-L1 score – those with high levels of the marker usually respond best to the PD-1 immunotherapies such as Opdivo and its rival, Merck’s Keytruda.

BMS has tried to downplay the results, saying it has always seen the future of NSCLC in drug combinations, and already has many of these in development.

The deal with Bavarian Nordic is just the latest of these, and twins Opdivo with the Denmark-based company’s vaccine-based immunotherapy technologies.

CV301 targets two tumour-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types, including lung, bladder and colorectal cancer.

Preclinical data shows CV301 can upregulate PD-L1 by mounting an immune response against a tumour target. The upregulation of PD-L1 is a marker indicating the tumour is under attack from T-cells, potentially producing a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

“While we have discussed the potential benefit of combining our cancer vaccines with checkpoint inhibitors for some time, this is now within reach as we have once again been able to strike an agreement with the leading immune-oncology company in the world, this time to explore the potential synergy between our programmes to benefit patients with lung cancer. We look forward to the initiation of this study later this year,” stated Paul Chaplin, President and CEO of Bavarian Nordic (pictured).

The new combination trial has come about because of an existing partnership between the companies signed in March 2015. The deal, worth up to $1 billion, gives BMS an option on Bavarian’s Prostvac, a virus cancer immunotherapy to treat prostate cancer currently in a phase 3 pivotal trial.

Prostvac is also in a combination investigator-sponsored phase 2 trial in combination with BMS’s Yervoy.

Bavarian Nordic will retain all commercial rights for CV301, and BMS is under no obligation to the programme beyond contributing the drug material.