U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test. These approvals represent the first PD-1 inhibitors plus Trop-2-directed ADC regimen in advanced TNBC.

These approvals are based on data from the Phase 3 KEYNOTE-D19/ASCENT-04 trial demonstrating that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.51-0.84]; p=0.0009) versus KEYTRUDA plus chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin) for the first-line treatment of adult patients with PD-L1+ (CPS ≥10) unresectable locally advanced or metastatic TNBC. KEYTRUDA plus Trodelvy resulted in a median progression-free survival (PFS) of 11.2 months [95% CI, 9.3-16.7] versus 7.8 months [95% CI, 7.3-9.3] with KEYTRUDA plus chemotherapy. The objective response rate (ORR) was higher with KEYTRUDA plus Trodelvy (61% [95% CI, 55-68]) than with KEYTRUDA plus chemotherapy (55% [95% CI, 48-62]), and complete responses occurred in 12% and 8% of patients, respectively. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK‑3475A‑D77 comparing the pharmacokinetic, efficacy and safety profiles of KEYTRUDA QLEX and KEYTRUDA.