Roche discount wins Tecentriq first-in-class NICE backing for bladder cancer

tecentriq
Roche's Tecentriq is a PD-L1 immunotherapy approved in a variety of cancers, and some unexpectedly poor trial data in bladder cancer earlier this year surprised analysts.

Roche's Tecentriq first hit the market as a bladder cancer therapy last year, but new data have since failed to prove it can extend those patients' lives. That didn't stop England's cost-effectiveness watchdogs from slotting the treatment onto its special Cancer Drugs Fund, however—a feat Tecentriq's fellow I-O meds haven't yet achieved in that cancer type.

The National Institute for Health and Care Excellence said Wednesday it was backing Tecentriq for CDF coverage in bladder cancer, specifically for patients ineligible for platinum-based chemo. It's NICE's first blessing for a PD-1/L1 checkpoint inhibitor in bladder cancer, and it follows a rejection for the drug handed down earlier this year.

After sifting the data, NICE reviewers said Tecentriq is "likely to extend people’s lives by more than three months." Because the submitted data—from the ImVigor 210 trial—"were immature and based on a small number of patients .. there is considerable uncertainty about the results," but clinical experts said the response rates and overall survival data ... match their clinical experience." Some patients whose disease initially responds well to treatment sustain a lasting response, the agency noted.

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The drug's assessment in patients who've failed on platinum chemo is still pending because of new data that surfaced during the agency's analysis, presumably the overall survival data from ImVigor 211.

Tecentriq took a surprising punch when it failed that follow-up trial, putting its conditional FDA approval, based on ImVigor 210, in jeopardy. But the threat of losing FDA approval in bladder cancer has now passed, the company said in September after discussions with the U.S. agency. That applies to Tecentriq’s green light in previously untreated patients ineligible for cisplatin chemo and in patients who’ve had previous platinum therapy.

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Tecentriq is competing against PD-1/L1 market leaders Opdivo and Keytruda, from Bristol-Myers Squibb and Merck & Co., as well as two newer entrants into the class, Pfizer and Merck KGaA’s Bavencio and AstraZeneca’s Imfinzi. None of these drugs has won NICE's backing, either for routine use by the National Health Service or through the CDF.

Tecentriq's performance in patients covered by the CDF will be tracked for three years, and NICE will review those results to determine whether the drug is cost-effective enough for routine coverage.