Shots:
- The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s review
- Trial showed that SC is noninferior to IV in AUC exposure & Ctrough along with improved 2EPs, incl. ORR (45.4% vs 42.1%), mDOR (9.1 vs 8mos.), & mPFS (8.1 vs 7.8mos.), while mOS was not reached in both arms
- Time & motion study demonstrated that SC dosing reduced pts chair time by 49.7% (59.0 vs 117.2min), room time by 47.4% (66.7 vs 126.9min), & HCP time by 45.7% (4 vs 25.8min), incl. 44.6% in preparation (5.1 vs 9.2min) & 46.7% in administration/monitoring (8.9 vs 16.7min); data was published in the Annals of Oncology
Ref: Merck | Image: Merck
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