Shots:
- The US FDA has approved Trodelvy + Keytruda/Keytruda Qlex for the 1L treatment of adults with inoperable, locally advanced, or metastatic TNBC expressing PD-L1 (CPS ≥ 10)
- Approval was based on the P-III (ASCENT-04/KEYNOTE-D19) trial assessing Trodelvy (10mg/kg, IV, Day 1 & 8 of each 21-day cycle) + Keytruda (200mg, IV, Day 1 of each 21-day cycle) (n=221) vs Keytruda + CT (n=222) in the above-mentioned pts (n=443)
- Trial showed a 35% reduction in the risk of disease progression or death, with an mPFS of 11.2 vs 7.8mos. & ORR of 61% vs 55% (CR: 12% vs 8%). Keytruda Qlex efficacy was supported by Keytruda studies & MK-3475A D77 data showing comparable PK, efficacy, & safety
Ref: Businesswire | Image: Merck & Gilead | Press Release
Related News: Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)
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