In a key triumph for Roche’s runner-up checkpoint Tecentriq, the FDA sanctioned a combo of the PD-L1 with Celgene’s Abraxane for frontline use in triple negative breast cancer.
The accelerated approval marks the first cancer immunotherapy regimen approved for this type of metastatic cancer, the pharma giant said, just months after reporting some historic Phase III data on progression-free survival.
In the IMpassion130 study, Tecentriq plus Abraxane (the chemotherapy nab-paclitaxel) “significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone,” with a median PFS of 7.4 months versus 4.8 months. The hazard ratio came in at 0.60 and p<0.0001.
Tecentriq is now sanctioned to treat patients whose tumors express PD-L1 — something that needs to be verified by a companion diagnostic from Roche. Approved concurrently for this indication, the VENTANA PD-L1 (SP142) Assay scans tumor-infiltrating immune cells for PD-L1.
Targeted therapy has long eluded patients suffering from triple negative breast cancer, as the common types of receptors — estrogen receptor, progesterone receptor and HER2/neu – are not expressed on their tumors. The approval of Tecentriq represents “a meaningful step forward in the understanding of this disease,” said Roche head of global development Sandra Horning.
Trailing behind Merck and Bristol-Myers Squibb, the pharma giant will need to get out well ahead of the competition in key cancer areas if they expect to hold on to their third-ranked position in the market, as AstraZeneca moves ahead with its advantage in one important niche of non-small cell lung cancer.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 45,000+ biopharma pros who read Endpoints News by email every day.Free Subscription