FDA approves Keytruda and Keytruda Qlex with Trodelvy as first-line PD-L1-high triple-negative breast cancer treatment

The FDA approved Keytruda and Keytruda Qlex, each combined with Trodelvy (sacituzumab govitecan), as first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (CPS of 10 or more). In the KEYNOTE-D19 (ASCENT-04) trial, the combination reduced the risk of progression or death by 35% versus Keytruda plus chemotherapy, with median progression-free survival of 11.2 months versus 7.8 months. The approval extends Keytruda's breast cancer reach into the first-line setting.

• Population: PD-L1 CPS of 10 or more, first-line metastatic or unresectable
• Progression-free survival hazard ratio 0.65 (p=0.0009)
• Median progression-free survival 11.2 vs 7.8 months
• 443 patients randomized 1:1