BMS keeps foot on immuno-oncology accelerator

A filing for anti-PD-1 drug Opdivo in lung cancer, plus three new licensing and acquisition deals, shows Bristol-Myers Squibb (BMS) has no intention of slowing its immuno-oncology drive.

The US FDA has just granted priority review for Opdivo (nivolumab) as a second-line treatment for advanced squamous non-small cell lung cancer (NSCLC), setting up a potential approval by 22 June to add to the drug's existing use in melanoma after initial treatment with BMS' Yervoy (ipilimumab).

The filing for Opdivo gives BMS a lead in NSCLC over arch-rival Merck & Co, whose Keytruda (pembrolizumab) PD-1 inhibitor is due to be filed in the first half of 2015. Keytruda beat Opdivo to the US market in the melanoma indication.

BMS' latest marketing submission is based on data from the phase II CheckMate-063 trial, which revealed a one-year survival rate of 41 per cent in patients given the drug.

Prostate cancer vaccine

BMS has also just inked a deal with Denmark's Bavarian Nordic – worth up to $975 million – to get an option on a prostate cancer immunotherapy candidate that is in phase III testing.

The agreement comes just a few days after the US pharma major agreed a $1.2 billion deal to acquire Flexus Biosciences and a $399 million alliance with Rigel Pharmaceuticals, both of which are focusing on the development of immune-modulating therapeutics with applications in oncology.

The deal with Bavarian Nordic centres on Prostvac, a vaccine targeting prostate specific antigen (PSA), a well-known biomarker for prostate cancer. The Danish company is in the midst of a pivotal trial looking at Prostvac's potential in asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

BMS is paying $60 million upfront for an option to license Prostvac, with another $80 million due if it exercises that and another $230 million if the immunotherapy shows a better impact on overall survival in phase III than was seen in an earlier phase II trial.

The Danish company is also in line for $110 million in regulatory milestone payments, up to $495 million in sales milestones and double-digit royalties on future sales of the product.

Prostvac will also be tested alongside Yervoy in a phase II prostate cancer trial, said BMS in a statement. Yervoy has become a big-seller in melanoma but the US drugmaker is keen to extend its use into other cancers, and has a phase III trial ongoing in prostate cancer.

If approved, BMS will be hoping that Prostvac will fare better in the marketplace than prostate cancer vaccine rival Provenge from Dendreon, which failed to make enough headway in the market and has just been taken over by Valeant in a deal valued at $296 million.

Provenge had sales of $300 million in 2014, despite a slightly convoluted production process which involves harvesting cells from a patient, modifying and re-injecting them. Prostvac is designed to be used off-the-shelf. Analysts have suggested Prostvac could achieve more than $1 billion a year at peak.