Article Text

Download PDFPDF

#1121 KEYNOTE-826: final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab + chemotherapy vs placebo + chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer
  1. Bradley J Monk1,
  2. Nicoletta Colombo2,
  3. Krishnansu Sujata Tewari3,
  4. Coraline Dubot4,
  5. M Valeria Caceres5,
  6. Kosei Hasegawa6,
  7. Ronnie Shapira-Frommer7,
  8. Pamela Salman8,
  9. Eduardo Yañez9,
  10. Mahmut Gumus10,
  11. Mivael Olivera Hurtado De Mendoza11,
  12. Vanessa Samouëlian12,
  13. Vincent Castonguay13,
  14. Alexander Arkhipov14,
  15. Cumhur Tekin15,
  16. Kan Li15,
  17. Stephen Michael Keefe15 and
  18. Domenica Lorusso16
  1. 1HonorHealth, University of Arizona, Creighton University, Phoenix, USA
  2. 2Gynecologic Oncology, European Institute of Oncology IRCCS and Università degli Studi di Milano Bicocca, Milano, Italy
  3. 3Obstetrics and Gynecology, University of California, Irvine Orange, Irvine, USA
  4. 4Oncologie Médicale, Institut Curie Saint Cloud, and GINECO, Paris, France
  5. 5Medical Oncology, Instituto de Oncologia Angel H. Roffo Mayor Irusta 3777, Buenos Aires, Argentina
  6. 6Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan
  7. 7Ella Lemelbaum Institute for Immuno Oncology and Melanoma, Sheba Medical Center, Ramat Gan, Israel
  8. 8Medical Oncology, Oncovida Cancer Center, Providencia Santiago, Chile
  9. 9Medical Oncology, Universidad de la Frontera, Temuco, Chile
  10. 10Medical Oncology, Istanbul Medeniyet University Hospital, Istanbul, Tunisia
  11. 11Medical Oncology, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru
  12. 12Gynecologic Oncology, Centre Hospitalier de l’Université de Montréal (CHUM), Centre de Recherche de l’Université de Montréal (CRCHUM), Université de Montréal, Montreal, Canada
  13. 13Medical Oncology, Centre Hospitalier Universitaire de Québec, Université Laval, Quebec City, Canada
  14. 14Oncology and Chemical Therapy, Medical Rehabilitation Center under the Ministry of Health of Russian Federation, Moscow, Russia
  15. 15Oncology, Merck and Co., Inc., Rahway, USA
  16. 16Gynaecology Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy


Introduction/Background The first interim analysis of KEYNOTE-826 (NCT03635567) showed that first-line pembrolizumab (pembro) + chemotherapy (chemo) provided statistically significant and clinically meaningful improvements in OS and PFS vs placebo (pbo) + chemo in patients (pts) with recurrent, persistent, or metastatic cervical cancer across all prespecified populations (PD-L1 combined positive score [CPS] ≥1, all-comer, and CPS ≥10). Here, we present the protocol-specified final OS analysis results of KEYNOTE-826.

Methodology Eligible adults with persistent, recurrent, or metastatic cervical cancer not previously treated with systemic chemo (prior radiosensitizing chemo allowed) and not amenable to curative treatment (surgery or radiation) were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 35 cycles + chemo (paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 or carboplatin AUC 5), ± bev 15 mg/kg. Pts were stratified by metastatic status at diagnosis (yes/no), planned bev use (yes/no), and PD-L1 CPS ( < 1, 1 to < 10, or ≥10). Dual primary end points were OS and PFS per RECIST v1.1 assessed by investigator review, each tested sequentially in the PD-L1 CPS ≥1, all-comer, and CPS ≥10 populations.

Results From Nov 2018 to Jan 2020, 617 patients were randomized (pembro + chemo, n = 308 [63.6% with bev]; pbo + chemo, n = 309 [62.5% with bev]); 548 (88.8%) pts had PD-L1 CPS ≥1 and 317 (51.4%) had CPS ≥10. At the Oct 3, 2022 data cutoff, median follow-up was 39.1 mo. Pembro + chemo significantly improved OS and PFS in the CPS ≥1, all-comer, and CPS ≥10 populations (table 1). The pembro + chemo benefit was seen regardless of bev use. Grade ≥3 AE incidence was 82.4% in the pembro + chemo arm and 75.4% in the placebo + chemo arm. The most common grade ≥3 AEs were anemia (30.3% vs 27.8%), neutropenia (12.4% vs 9.7%), and hypertension (10.4% vs 11.7%).

Abstract #1121 Table 1

Conclusion The addition of pembro to chemo ± bev significantly reduced the risk of death by 40% in the PD-L1 CPS ≥1 population, by 37% in the all-comer population, and by 42% in the CPS ≥10 population, and had a manageable safety profile. These data are consistent with the earlier results and provide further support for pembro + chemo ± bev as a new standard of care for first-line treatment of persistent, recurrent, or metastatic cervical cancer.

Disclosures .

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.