Bristol-Myers, Bavarian Nordic to advance Opdivo combo in NSCLC after recent trial failure


Bristol-Myers Squibb ($BMY) is still reeling from a Phase III trial failure of Opdivo (nivolumab) to treat first-line non-small cell lung cancer (NSCLC)--after losing billions in market cap. Now, it’s adding to an existing partnership with Bavarian Nordic to start a Phase II combo trial of Opdivo with Bavarian’s cancer vaccine CV301 in previously treated NSCLC.

The pharma has said it is looking to combinations, in particular with another of its immunotherapies, Yervoy (ipilimumab), as a way forward on Opdivo in untreated NSCLC; the relatively low 5% rate of PD-L1 expression used in the trial, as opposed to that used in a similar study of competitor Keytruda (pembrolizumab) from Merck ($MRK), was also widely criticized by industry observers.

Under the new clinical development collaboration with Bavarian Nordic, BMS will supply Opdivo for a Phase II clinical trial in combination with CV301 to treat previously treated NSCLC patients. The Bavarian candidate targets cancer antigens CEA and MUC1 and upregulates PD-L1. The companies hope that the combination, a PD-1 immune checkpoint inhibitor, will offer greater benefit than Opdivo alone.

The trial is slated to enroll about 160 patients and will specifically be in patients with previously treated NSCLC--an indication for which Opdivo is already FDA-approved. Bavarian Nordic retains all rights to CV301, which was originally developed by the National Cancer Institute.

“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 programs to benefit patients with lung cancer,” said Bavarian Nordic President and CEO Paul Chaplin in a statement.

He added, “We look forward to the initiation of this study later this year,”

 The initial partnership between Bavarian and Bristol-Myers dates back to March 2015--and is worth up to $1 billion. It’s specifically an option deal for the former’s Prostvac, a prostate-specific antigen (PSA)-targeting cancer immunotherapy to treat prostate cancer.

At the time of the deal, Prostvac was already in an investigator-sponsored Phase II trial in combination with BMS’s Yervoy. The partners planned to do one or more exploratory combination studies of Prostvac with BMS immuno-oncology agents.

- here is the release

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