Yervoy setback in prostate cancer
pharmafile | September 16, 2013 | News story | Research and Development, Sales and Marketing | BMS, Yervoy, melanoma, prostate cancer
Bristol-Myers Squibb has suffered a setback as its melanoma drug Yervoy failed to reach the primary endpoint in a trial designed to expand its reach.
The randomised, double-blind Phase III study of Yervoy (ipilimumab) versus placebo followed radiation in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who had received prior treatment with docetaxel.
It did not reach statistical significance in overall survival (OS) – however, BMS is encouraged by anti-tumour activity seen in progression-free survival (PFS) and the company is determined not to give up with the drug in this therapy area.
Median OS was 11.2 months for Yervoy and 10 months for placebo, with a hazard ratio of 0.85. Meanwhile, one- and two-year survival rates for the drug were 47% versus 40% and 26% versus 15 per cent.
The Yervoy arm produced better median PFS than placebo – data will be presented at the 2013 European Cancer Congress on 28 September.
“While we are disappointed that the primary endpoint of OS was not met, we remain encouraged that results in this advanced population support the potential role of immunotherapies for prostate cancer,” said Brian Daniels, BMS senior vice president, global development and medical affairs.
Adverse events – which were common and most of which were gastrointestinal – tended to be immune-related and were similar to those already observed with the drug.
BMS is now pinning its hopes on Yervoy being more active in patients with less advanced CRPC: another Phase III study, looking at OS, is ongoing with Yervoy in patients in this group who have received no prior cytotoxic treatment.
Indicated for unresectable or metastatic melanoma in a number of countries, Yervoy is also in Phase III trials for adjuvant melanoma and non-small cell lung cancer.
The recombinant, human monoclonal antibody blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4) – a negative regulator of T-cell activation – by binding to it a blocking its interaction with ligands CD80/CD86.
Adam Hill
Related Content
Five facts about UV exposure and sun safety
1We can acclimatise to UV exposure. For example, we’re more likely to burn if there’s …
Johnson & Johnson seeks EMA approval to accelerate prostate cancer treatment
Johnson & Johnson has submitted an application to the European Medicines Agency for an indication …
Biocon Biologics gains EU approval for bone health therapies
Biocon Biologics has announced that the European Commission has granted marketing authorisation for its denosumab …
