Αρχική World News Immunotherapy Prolongs Survival in Recurrent, Persistent or Metastatic Cervical Cancer

Immunotherapy Prolongs Survival in Recurrent, Persistent or Metastatic Cervical Cancer [ESMO Congress 2021 Press Release]

LBA2_PR – Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for persistent, recurrent, or metastatic cervical cancer: Randomized, double-blind, phase 3 KEYNOTE-826 study

N. Colombo1, C. Dubot2, D. Lorusso3, V. Cáceres4, K. Hasegawa5, R. Shapira-Frommer6, K.S. Tewari7, P. Salman8, E. Hoyos9, E. Yañez10, M. Gumus11, M. Olivera Hurtado de Mendoza12, V. Samouëlian13, V. Castonguay14, A. Arkhipov15, S. Toker16, K. Li16, S.M. Keefe16, B.J. Monk17

1Gynecologic Oncology, European Institute of Oncology IRCCS and Università degli Studi di Milano Bicocca, Milan, Italy, 2Oncologie Médicale, Institut Curie Saint Cloud, and GINECO, Paris, France, 3Gynaecology Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy, 4Medical Oncology, Instituto de Oncologia Angel H. Roffo, Buenos Aires, Argentina, 5Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan, 6Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel, 7Obstetrics & Gynecology, University of California, Irvine, Orange, United States of America, 8Medical Oncology, Oncovida Cancer Center, Providencia, Santiago, Chile, 9Medical Oncology, IMAT Oncomedica S.A., Monteria, Colombia, 10Medical Oncology, Universidad de la Frontera, Temuco, Chile, 11Medical Oncology, Istanbul Medeniyet University Hospital, Istanbul, Turkey, 12Medical Oncology, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru, 13OB-GYN, Centre Hospitalier de l’Université de Montréal (CHUM), Centre de Recherche de l’Université de Montréal (CRCHUM), Université de Montréal, Montreal, Canada, 14Medical Oncology, Centre Hospitalier Universitaire de Québec, Université Laval, Quebec City, Canada, 15Oncology and chemical therapy, Medical Rehabilitation Center under the Ministry of Health of Russian Federation, Moscow, Russian Federation, 16Oncology, Merck & Co., Inc., Kenilworth, United States of America, 17Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, United States of America

Background: Pembrolizumab (pembro) shows efficacy in patients (pts) with previously treated, PD-L1–positive advanced cervical cancer. In KEYNOTE-826 (NCT03635567), we evaluated the efficacy and safety of pembro + chemotherapy (chemo) ± bevacizumab (bev) for recurrent, persistent, or metastatic cervical cancer.

Methods: 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 were randomized 1:1 to pembro 200 mg or placebo Q3W for ≤35 cycles added to chemo (paclitaxel + cisplatin or carboplatin) ± bev. Pts were stratified by metastatic status at diagnosis, planned bev use, and PD-L1 combined positive score (CPS). Dual primary end points were PFS per RECIST v1.1 assessed by investigator review and OS, each tested sequentially in the PD-L1 CPS ≥1, all-comer, and CPS ≥10 populations. All data are from the protocol-specified first interim analysis (May 3, 2021 data cutoff).

Results: From Nov 2018 to Jan 2020, 617 pts were randomized to pembro + chemo (N = 308; 63.6% with bev) or placebo + chemo (N = 309; 62.5% with bev); 548 (88.8%) pts had PD-L1 CPS ≥1 and 317 (51.4%) had CPS ≥10. Pembro + chemo significantly improved PFS and OS in the CPS ≥1, all-comer, and CPS ≥10 populations (Table). The pembro + chemo benefit was seen regardless of bev use. Grade ≥3 AE incidence was 81.8% in the pembro + chemo arm and 75.1% in the placebo + chemo arm. The most common grade ≥3 AEs were anemia (30.3% vs 26.9%) and neutropenia (12.4% vs 9.7%).

PD-L1 CPS ≥1

All-Comer

PD-L1 CPS ≥10

Pembro + Chemo
 (N = 273)

Placebo + Chemo
 (N = 275)

Pembro + Chemo
 (N = 308)

Placebo + Chemo
 (N = 309)

Pembro + Chemo
 (N = 158)

Placebo + Chemo
 (N = 159)

PFS per RECIST v1.1 by investigator review

Median, mo

10.4

8.2

10.4

8.2

10.4

8.1

12-mo rate, %

45.5

34.1

44.7

33.5

44.6

33.5

HR (95% CI)

0.62 (0.50-0.77);
 P < 0.001

0.65 (0.53-0.79);
 P < 0.001

0.58 (0.44-0.77);
 P < 0.001

OS

Median, mo

NR

16.3

24.4

16.5

NR

16.4

24-mo rate, %

53.0

41.7

50.4

40.4

54.4

44.6

HR (95% CI)

0.64 (0.50-0.81);
 P < 0.001

0.67 (0.54-0.84);
 P < 0.001

0.61 (0.44-0.84);
 P = 0.001

Conclusions: Pembro + chemo provided statistically significant, clinically meaningful PFS and OS improvements in pts with persistent, recurrent, or metastatic cervical cancer, regardless of PD-L1 expression and concomitant bev use. Along with a manageable safety profile, these data suggest pembro + chemo ± bev may be a new standard of care for this population.

Clinical trial identification: NCT03635567.

Editorial acknowledgement: Medical writing and/or editorial assistance was provided by Melanie Leiby of Merck & Co., Inc., Kenilworth, NJ, USA. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Legal entity responsible for the study: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure: N. Colombo: Financial Interests, , Invited Speaker: AstraZeneca, MSD/Merck, Novartis, Clovis, GSK; Financial Interests, , Advisory Board: Roche, Pharmamar, AstraZeneca, MSD/Merck, Clovis Oncology, Tesaro, GSK, Pfizer, Takeda, BIOCAD, Immunogen, Mersana, Eisai, Oncxerna; Financial Interests, , Funding: Roche, AstraZeneca.
C. Dubot: Financial Interests, Institutional, Funding: MSD.
D. Lorusso: Financial Interests, Personal and Institutional, Funding, funding/advisory role: MSD; Financial Interests, Personal and Institutional, Funding, funding/advisory role: Clovis Oncology; Financial Interests, Personal and Institutional, Funding, funding/advisory role: GSK; Financial Interests, Personal and Institutional, Funding, funding/advisory role: AstraZeneca; Financial Interests, Personal and Institutional, Funding, funding/advisory role: Pharmamar; Financial Interests, Personal, Advisory Role: Merck Serono; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Amgen.
V. Cáceres: Financial Interests, Institutional, Funding: MSD.
K. Hasegawa: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Role: MSD.
R. Shapira-Frommer: Financial Interests, Institutional, Funding: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: VBL Therapeutics.
K.S. Tewari: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Tesaro; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Speaker’s Bureau: Eisai.
P. Salman: Financial Interests, Institutional, Principal Investigator: MSD.
E. Hoyos: Financial Interests, Institutional, Funding: MSD.
E. Yañez: Financial Interests, Institutional, Funding: MSD.
M. Gumus: Financial Interests, Institutional, Funding: MSD.
M. Olivera Hurtado de Mendoza: Financial Interests, Institutional, Funding: MSD; Financial Interests, Personal and Institutional, Principal Investigator: MSD.
V. Samouëlian: Financial Interests, Institutional, Funding: MSD.
V. Castonguay: Financial Interests, Personal, Advisory Board: MSD.
A. Arkhipov: Financial Interests, Institutional, Funding: MSD; Financial Interests, Personal, Principal Investigator: MSD.
S. Toker: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme Corp.; Financial Interests, Personal, Stocks/Shares: Merck Sharp & Dohme Corp..
K. Li: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme Corp..
S.M. Keefe: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme Corp.; Financial Interests, Personal, Stocks/Shares: Merck Sharp & Dohme Corp..
B.J. Monk: Financial Interests, Institutional, Funding: MSD; Financial Interests, Personal, Leadership Role: US Oncology; Financial Interests, Personal, Other, honoraria/consulting: AbbVie; Financial Interests, Personal and Institutional, Other, honoraria/consulting, funding: Advaxis; Financial Interests, Personal, Other, honoraria/consulting: Agenus; Financial Interests, Personal, Other, honoraria/consulting: Akeso Biopharma; Financial Interests, Personal and Institutional, Other, honoraria/consulting, funding: Amgen; Financial Interests, Personal, Other, honoraria/consulting: Aravive; Financial Interests, Personal and Institutional, Other, honoraria/consulting/speakers’ bureau, funding: AstraZeneca; Financial Interests, Personal, Other, honoraria/consulting: Asymmetric Therapeutics; Financial Interests, Personal, Other, honoraria/consulting: Boston Biomedical; Financial Interests, Personal, Other, honoraria/consulting: ChemoID; Financial Interests, Personal, Other, honoraria/consulting/speakers’ bureau: Clovis Oncology; Financial Interests, Personal, Other, honoraria/consulting: Deciphera Pharmaceuticals; Financial Interests, Personal, Other, honoraria/consulting/speakers’ bureau: Eisai; Financial Interests, Personal, Other, honoraria: Elevar Therapeutics; Financial Interests, Personal, Other, honoraria/consulting: Geistlich Pharma; Financial Interests, Personal, Advisory Role: ChemoCare; Financial Interests, Personal, Other, honoraria/consulting : Genmab/Seattle Genetics; Financial Interests, Personal, Other, honoraria/consulting: GOG Foundation; Financial Interests, Personal, Other, honoraria/consulting: Gradalis; Financial Interests, Personal and Institutional, Other, honoraria/consulting, funding: ImmunoGen; Financial Interests, Personal, Other, honoraria/consulting: Immunomedics; Financial Interests, Personal, Other, honoraria/consulting: Incyte; Financial Interests, Personal, Other, honoraria/consulting: Iovance Biotherapeutics; Financial Interests, Personal, Other, honoraria/consulting: Karyopharm Therapeutics; Financial Interests, Personal, Other, honoraria/consulting: Laekna Health Care; Financial Interests, Personal, Other, honoraria/consulting/speakers’ bureau: Merck; Financial Interests, Personal, Other, honoraria/consulting: Mersana; Financial Interests, Personal, Other, honoraria/consulting: Myriad Pharmaceuticals; Financial Interests, Personal, Other, honoraria/consulting : Novocure; Financial Interests, Personal and Institutional, Other, honoraria/consulting, funding: Nucana; Financial Interests, Personal, Other, honoraria/consulting: Oncomed; Financial Interests, Personal, Other, honoraria/consulting : Oncoquest; Financial Interests, Personal, Other, honoraria/consulting: Oncosec; Financial Interests, Personal, Other, honoraria/consulting: Perthera; Financial Interests, Personal and Institutional, Other, honoraria/consulting, funding: Pfizer; Financial Interests, Personal, Other, honoraria/consulting: Puma Biotechnology; Financial Interests, Personal and Institutional, Other, honoraria/consulting, funding: Regeneron; Financial Interests, Personal, Other, honoraria/consulting/speakers’ bureau: Roche/Genentech; Financial Interests, Personal, Other, honoraria/consulting: Senti Biosciences; Financial Interests, Personal, Other, honoraria: Starton Therapeutics; Financial Interests, Personal, Other, honoraria/consulting: Takeda; Financial Interests, Personal, Other, honoraria/consulting: Tarveda Therapeutics; Financial Interests, Personal, Other, honoraria/consulting/speakers’ bureau: Tesaro/GSK; Financial Interests, Personal, Other, honoraria/consulting: Vascular Biogenics; Financial Interests, Personal, Other, honoraria/consulting: Vavotar Life Sciences; Financial Interests, Personal, Other, honoraria/consulting: Vigeo Therapeutics; Financial Interests, Personal, Advisory Role: Sorrento Therapeutics; Financial Interests, Institutional, Funding: Array BioPharma; Financial Interests, Institutional, Funding: Genentech; Financial Interests, Institutional, Funding: Janssen; Financial Interests, Institutional, Funding: Lilly; Financial Interests, Institutional, Funding: Morphotek; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: Tesaro.

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