Roche may be able to keep its bladder cancer nod for Tecentriq despite its phase 3 failure to improve overall survival. But that doesn’t mean it can keep its market share.
Use of the med in the bladder-cancer space has been declining, with rival Keytruda from Merck “displacing Tecentriq,” Barclays analysts wrote to investors Thursday. Roche’s drug, which was the first immuno-oncology agent of five to win a green light in the field, accounts for the greatest overall share of the bladder-cancer market--and half the immuno-oncology market for the indication. But “use has been declining,” they said.
The Swiss pharma giant first ran into trouble in May, when it announced that Tecentriq--approved last year on the basis of phase 2 data durable response data--couldn’t significantly top chemo in a phase 3 study. The flop put Tecentriq’s approval in question and raised red flags for fellow PD-1/PD-L1 drugmakers who, aside from Merck, can’t yet boast positive OS data of their own.
What caused the surprise skid? A surprisingly good performance from vinflunine, a chemo med that represents the standard of care in Europe, Roche global head of clinical development in hematology and oncology Dietmar Berger said in an interview at this year’s American Society of Clinical Oncology annual meeting.
“If you look at the study, the Tecentriq arm performed exactly as it did” in phase 2, he said, and it was also “very much in line with many of the data that we see from other checkpoint inhibitors.”
And the FDA apparently saw enough positives in Tecentriq’s performance to let the med keep its go-ahead; last month, a spokeswoman for Roche’s Genentech unit said that after discussions with the agency, the company expects that the product’s accelerated approval “will be maintained.”
Roche has plenty of new company in the bladder cancer space, though--including Keytruda, which was the last PD-1/PD-L1 med of the five currently on the market to pick up a bladder cancer OK. It’s also the only one to have shown it can significantly beat out chemo in the OS department; at October’s European Society for Medical Oncology (ESMO) annual meeting in Madrid, the New Jersey drugmaker touted phase 3 results showing that in the second-line setting, Keytruda continued to demonstrate an overall survival advantage over chemo at a median follow-up of 22.5 months.