Shots:
- The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes
- Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W; n=126), both in combination with Pt-doublet CT in treatment-naive metastatic NSCLC adults (n=377) with no EGFR, ALK or ROS1 mutations
- Trial showed that Keytruda SC is comparable to Keytruda in PK exposure levels, plus achieved ORR of 45% vs 42%, with comparable PFS & OS observed between the two
Ref: Merck | Image: Merck | Press Release
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