Roche's Tecentriq cedes bladder-cancer share to Keytruda in wake of trial misfire

Roche's Tecentriq has ceded market share to Merck's Keytruda after its bladder cancer trial failure.

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.

RELATED: Roche’s shocking Tecentriq fail raises red flag for bladder cancer rivals

Survey

Veeva 2020 Unified Clinical Operations Survey

We believe you have the knowledge and expertise to make this year's Veeva 2020 Clinical Operations Report even more robust and insightful than the last. Please take a moment to share your opinion in this 10-minute survey. All qualified respondents will be entered to win a $500 Amazon gift card.

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.”

RELATED:  The gang's all here: Merck's Keytruda nabs I-O's third bladder cancer approval this month

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.

Suggested Articles

Only months removed from a gamechanging label expansion for Vascepa, Amarin is scrambling after a district judge invalidated the drug's key patents.

Move over, Roche. There’s a new small-cell lung cancer therapy on the scene, and it belongs to AstraZeneca.

Fujifilm says it is prepared to ramp up production of Avigan for any country that wants to try it as a potential treatment for COVID-19.