Bristol-Myers Squibb’s Opdivo is now under regulatory review in the EU as a second-line treatment for bladder cancer, setting up a head-to-head between the drug and Roche’s Tecentriq.
The EU regulator has agreed to start its review of BMS’ application based on the results of the phase II CheckMate-275 study of PD-1 inhibitor Opdivo (nivolumab) in metastatic urothelial carcinoma (UC) patients previously treated with platinum-based chemotherapy.
UC accounts for around 90% of all cases of bladder cancer, which in turn is the fifth most common cancer affecting almost 430,000 people every year.
Approval in that large indication would give Opdivo a boost after a disappointing outcome in a first-line non-small cell lung cancer (NSCLC) trial that handed a competitive advantage to rival PD- inhibitor – Merck & Co’s Keytruda (pembrolizumab) – in that indication.
The filing puts BMS just behind Roche in the EU race to market for immuno-oncology treatments for bladder cancer. Roche has already bagged a US approval for PD-L1 inhibitor Tecentriq (atezolizumab) for second-line UC in the US and seems to have filed the drug for that indication in Europe – although the company has made no public announcement to that effect.
Keytruda has also shown efficacy in bladder cancer but according to Merck’s latest pipeline update has not yet been filed for approval in this indication. Meanwhile, BMS is also talking to the FDA about a marketing application based on the CheckMate-275 data, which is due to be reported at the European Society for Medical Oncology (ESMO) congress next month.
Bladder cancer has proved to be remarkably resistant to new drug therapy. The standard of care remains cisplatin and there have been few treatment advances over the last 30 years, so immuno-oncology agents are expected to make swift and dramatic headway both in the second- and first-line treatment settings.
Analysts have predicted that Tecentriq could become a $3bn product if its first-mover advantage in bladder cancer is bolstered by follow-up approvals in lung, colorectal, urogenital and kidney cancers.