Roche’s Tecentriq set the bar for immuno-oncology meds with a first-ever approval by the FDA in triple-negative breast cancer (TNBC) and a follow-up nod in Europe. However, the U.K.’s drug cost watchdog wasn’t impressed—and it’s sending Roche back to the drawing board.
The National Institute for Health and Care Excellence (NICE) turned away Tecentriq as an add-on to chemotherapy Abraxane (nab-paclitaxel) as a cost-effective option on England’s National Health Service.
Despite acknowledging that the combo beat out a placebo-chemo combo at staving off disease progression by 2.5 months in patients with whose tumors express biomarker PD-L1, NICE knocked Roche for scanty clinical data comparing the combo to other chemo meds, including weekly paclitaxel and docetaxel.
"The committee felt that the company’s analysis indirectly comparing these treatments was unreliable and lacked validity," NICE said.
NICE’s rebuff will put the ball in Roche’s court to either supplement its data submission or consider a further confidential discount with the watchdog. In a statement, Meindert Boysen, NICE’s director of the Centre for Health Technology Evaluation, said he expected U.K. patients would be disappointed by the results but pledged to continue working with Roche to reach a solution.
“The committee heard that the availability of a new treatment that increases progression-free survival compared with chemotherapy alone will give hope to patients because it is important to them to be able to maintain a good quality life for as long as possible,” Boysen said. “We are committed to working with the company to try to resolve the issues identified by the committee.”
The FDA approved Tecentriq in March as a combo treatment with Celgene’s Abraxane to treat new TNBC patients with tumors that test positive for the PD-L1 biomarker, becoming the first I-O drug in that indication. The European Commission followed that approval with one of their own in August.
Regulators based the decision on data from the phase 3 Impassion130 trial, which showed that adding Tecentriq to Abraxane in new patients could slash the risk of disease worsening or death by 20%. The combo kept cancer at bay for a median 7.2 months, compared with 5.5 months for solo Abraxane.
The TNBC market has so far been exclusively Tecentriq’s after powerhouse Keytruda from Merck flopped a trial of its own in the disease area.
Over the weekend, Merck unveiled details of Keytruda's phase 3 monotherapy miss in second-line metastatic TNBC. Pitted against chemo, the drug cut patients’ risk of death by 3% in the all-comer population, by 14% in a group of patients with low levels of PD-L1 and by 22% in a group of patients whose levels were higher, but it missed the statistical significance threshold.