Merck Reports US FDA’s Approval of Keytruda + Chemoradiotherapy for Treating FIGO 2014 Stage III-IVA Cervical Cancer
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- The approval was based on the P-III (KEYNOTE-A18) study of Keytruda (200mg, IV, Q3W, 5 cycles; 400mg, IV, Q6W, 15 cycles) + CRT vs PBO for treating cervical cancer patients (incl. 596 with stage III-IVA having either node+/- disease, 462 with stage IB2-IIB having node+ disease & 2 with stage IVB disease) without prior surgery, radiation, or systemic therapy
- The analysis of total 596 patients showed that in 61/293 patients in the Keytruda + CRT arm attained PFS vs 94/303 in the PBO arm. 12mos. PFS rate was 81% vs 70%. mPFS was not attained either arm
- Furthermore, an improved PFS of 41% was seen in the overall population and a PFS HR of 0.91 was seen in 462 stage IB2-IIB patients. OS data was immature during the PFS analysis
Ref: Merck | Image: Merck
Related News:- Merck’s Keytruda + Padcev Received the US FDA Approval for the Treatment of Urothelial Cancer
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
