Merck Backs Up Keytruda Approval In TNBC With Encouraging Overall Survival Data

Merck & Co Inc MRK announced the final overall survival (OS) results from the Phase 3 KEYNOTE-355 trial of Keytruda in combination with chemotherapy for the first-line metastatic triple-negative breast cancer (mTNBC).
Keytruda combined with chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in OS.
The data were presented at the European Society for Medical Oncology (ESMO21) Congress 2021.
A combination of Keytruda and chemotherapy reduced the risk of death by 27% over Chemo alone in previously untreated patients whose tumors expressed the PD-L1 biomarker at a combined positive score (CPS) of at least 10.
Adding Keytruda helped the patients live an additional 6.9 months or a median of 23 months versus 16.1 months in the Chemo alone group.
Keytruda snagged an accelerated approval in front-line triple-negative breast cancer in November.
In July, an FDA green light for its use around surgery for early-stage, high-risk TNBC converted that conditional nod into a full one.
Related Link: FDA Approves Merck's Keytruda/Chemo Combo For Early Breast Cancer.
Price Action: MRK shares are down 0.95% at $71.00 during the premarket session on the last check Monday.
Check out our coverage of the European Society for Medical Oncology Congress (ESMO21).