As it is, Merck will have to make do with pursuing its own combinations. If the results had been positive, it could have seized the advantage from Roche in the disease. Testing Keytruda as a monotherapy in this setting always looked like a more difficult feat to achieve, but the drug’s success as a monotherapy in other tumour types, such as non-small cell lung cancer, has emboldened Merck & Co. It said other endpoints were not formally tested per the study protocol because the primary endpoint of OS had not been met. The company announced yesterday that the drug had failed to meet its pre-specified primary endpoint of superior overall survival (OS). That approval was a first for checkpoint inhibitors in TNBC, but differed in that it was a combination of Tecentriq and chemotherapy (Celgene’s Abraxane, nab-paclitaxel).īy contrast, Merck & Co’s phase 3 Keynote-119 trial evaluated Keytruda as a monotherapy for the second or third-line treatment compared to chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). The disease, which accounts for 10-20% of all breast cancers, is seen as a key area of expansion for the PD-1 and PD-L1 checkpoint inhibitors, and Roche’s Tecentriq gained a significant victory when it was approved in the disease in the US in March. Merck & Co’s blockbuster Keytruda has suffered a rare setback, the immunotherapy failing to show benefits compared to standard chemotherapy in advanced triple negative breast cancer (TNBC).
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