Roche's Tecentriq grabs I-O's first European OK for triple-negative breast cancer

Back in March, Roche’s Tecentriq led its class of immuno-oncology drugs into the triple-negative breast cancer arena (TNBC), picking up the first FDA OK in the tough-to-treat disease. Now, it’s done the same across the pond.

The European Commission green-lighted the treatment Thursday in tandem with Celgene chemo med Abraxane for previously untreated TNBC patients whose tumors test positive for biomarker PD-L1. Roche has a corresponding diagnostic available in the EU to help ID patients who are eligible for the combination, it said.

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.

Now, Roche has the clearance it needs to start racking up sales in a market where its competitors aren’t yet playing—a chance that’s been relatively rare for Tecentriq, which hit the market behind classmates Keytruda from Merck and Opdivo from Bristol-Myers Squibb.

While Tecentriq was the first of the group into the bladder cancer field, those rivals and then somequickly followed. And though it last year beat Opdivo onto the previously untreated lung cancer scene, there it’s contending with a Merck drug that’s dominating in the sales department. Earlier this year, Tecentriq did win a first-in-class go-ahead in small cell lung cancer, but AstraZeneca’s Imfinzi is already threatening to step on its turf.

Not so in TNBC, though, where other companies trialing their drugs haven’t yet met with Roche’s level of success. In May, Keytruda suffered a rare trial miss, failing to extend the lives of previously treated TNBC patients.

Meanwhile, Tecentriq wasn’t the only cancer drug to get a boost from European regulators this week. They also approved Bristol-Myers Squibb and AbbVie’s multiple myeloma drug Empliciti for use alongside Celgene’s Pomalyst and dexamethasone in patients who have already failed two or more prior therapies, including Celgene’s Revlimid and a proteasome inhibitor.

Empliciti scored the same approval in the U.S. last November.

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