#KEYNOTE 048 RESULTS TRIAL#

P+C vs E showed favorable OS in pts with CPS ≥20 in Asia and non-Asia subgrps regardless of PD-L1 status, durable responses, and similar safety. P vs E showed favorable OS in Asia and non-Asia subgrps, regardless of PD-L1 status responses were durable, particularly among all non-Asia subgrps safety was favorable. HRs are from product-limit (Kaplan-Meier) method for censored data 95% CIs are based on Cox regression model with Efron’s method of tie handling with treatment as a covariate. Gr 3-5 drug-related AE rates with P vs E were 28.6% vs 76.9% in the Asia subgrp and 13.9% vs 67.2% in the non-Asia subgrp rates with P+C vs E were 71.9% vs 76.9% in the Asia subgrp and 70.8% vs 67.2% in the non-Asia subgrp.Table: 1136P Asia, CPS ≥20Ĭ, chemotherapy CI, confidence interval CPS, combined positive score DOR, duration of response E, EXTREME HR, hazard ratio mo, months ORR, objective response rate OS, overall survival P, pembrolizumab PFS, progression-free survival. ResultsĮfficacy is reported in the table.

Primary end points were progression-free survival and OS. Pts with R/M HNSCC not curable by local therapy and with no prior systemic therapy were randomized (1:1:1) to P 200 mg Q3W, P+C (cisplatin 100 mg/m 2 or carboplatin AUC 5 Q3W + 5-FU 1000 mg/m 2/day for 4 days Q3W), or E (cetuximab 400 mg/m 2 loading dose with 250 mg/m 2 subsequent infusion QW + C) until progressive disease, unacceptable toxicity, 6 cycles of C, or 24 months of P. Safety was favorable or similar to that of E. P+C significantly improved OS vs E in the total pop (P = 0.0034). At 2nd interim analysis, overall survival (OS) was significantly longer with P than E in patients (pts) with PD-L1 combined positive score (CPS) ≥20 (P = 0.0007) and CPS ≥1 (P = 0.0086) and was noninferior in the total population (pop).

#KEYNOTE 048 RESULTS TRIAL#

KEYNOTE-048 (NCT02358031) is a randomized, open-label, phase 3 trial of P or P + chemotherapy (C) vs EXTREME (E) as 1L therapy for R/M HNSCC. 14 Medicine, Ramathibodi Hospital, Mahidol University, Bangkok/TH.13 Medical Oncology, Merck & Co., Inc., 07033 - Kenilworth/US.11 Medical Oncology, Kindai University Faculty of Medicine, 589-8511 - Osaka/JP.10 Medical Oncology, Taipei Veterans General Hospital, Taipei/TW.9 Otolaryngology-head And Neck, Yokohama City University Graduate School of Medicine, Yokohama/JP.

8 Medical Oncology, China Medical University Hospital, Taichung/CN.

7 Medical Oncology, Medicine, Siriraj Hospital, Mahidol University, Bangkok/TH.

6 Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo/JP.

5 Medical Oncology, Chulalongkorn University, Bangkok/TH.

4 Medical Oncology, National Cheng Kung University, 704 - Tainan/TW.

3 Clinical Oncology, University of Malaya, Kuala Lumpur/MY.

2 Oncology, National Taiwan University Hospital, Taipei/TW.

1 Head And Neck Medical Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP.

Keynote 048 results