{"id":27453,"date":"2021-09-18T13:05:00","date_gmt":"2021-09-18T13:05:00","guid":{"rendered":"http:\/\/e2824fa3ad3e22b365485da60f777e57"},"modified":"2024-11-03T15:14:29","modified_gmt":"2024-11-03T15:14:29","slug":"immunotherapy-prolongs-survival-in-recurrent-persistent-or-metastatic-cervical-cancer-esmo-congress-2021-press-release","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/immunotherapy-prolongs-survival-in-recurrent-persistent-or-metastatic-cervical-cancer-esmo-congress-2021-press-release\/","title":{"rendered":"Immunotherapy Prolongs Survival in Recurrent, Persistent or Metastatic Cervical Cancer [ESMO Congress 2021 Press Release]"},"content":{"rendered":"

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

\n

N. Colombo<\/u>1<\/sup>, C. Dubot2<\/sup>, D. Lorusso3<\/sup>, V. C\u00e1ceres4<\/sup>, K. Hasegawa5<\/sup>, R. Shapira-Frommer6<\/sup>, K.S. Tewari7<\/sup>, P. Salman8<\/sup>, E. Hoyos9<\/sup>, E. Ya\u00f1ez10<\/sup>, M. Gumus11<\/sup>, M. Olivera Hurtado de Mendoza12<\/sup>, V. Samou\u00eblian13<\/sup>, V. Castonguay14<\/sup>, A. Arkhipov15<\/sup>, S. Toker16<\/sup>, K. Li16<\/sup>, S.M. Keefe16<\/sup>, B.J. Monk17<\/sup><\/p>\n

1<\/sup>Gynecologic Oncology, European Institute of Oncology IRCCS and Universit\u00e0 degli Studi di Milano Bicocca, Milan, Italy, 2<\/sup>Oncologie M\u00e9dicale, Institut Curie Saint Cloud, and GINECO, Paris, France, 3<\/sup>Gynaecology Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy, 4<\/sup>Medical Oncology, Instituto de Oncologia Angel H. Roffo, Buenos Aires, Argentina, 5<\/sup>Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan, 6<\/sup>Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel, 7<\/sup>Obstetrics & Gynecology, University of California, Irvine, Orange, United States of America, 8<\/sup>Medical Oncology, Oncovida Cancer Center, Providencia, Santiago, Chile, 9<\/sup>Medical Oncology, IMAT Oncomedica S.A., Monteria, Colombia, 10<\/sup>Medical Oncology, Universidad de la Frontera, Temuco, Chile, 11<\/sup>Medical Oncology, Istanbul Medeniyet University Hospital, Istanbul, Turkey, 12<\/sup>Medical Oncology, Instituto Nacional de Enfermedades Neopl\u00e1sicas, Lima, Peru, 13<\/sup>OB-GYN, Centre Hospitalier de l\u2019Universit\u00e9 de Montr\u00e9al (CHUM), Centre de Recherche de l\u2019Universit\u00e9 de Montr\u00e9al (CRCHUM), Universit\u00e9 de Montr\u00e9al, Montreal, Canada, 14<\/sup>Medical Oncology, Centre Hospitalier Universitaire de Qu\u00e9bec, Universit\u00e9 Laval, Quebec City, Canada, 15<\/sup>Oncology and chemical therapy, Medical Rehabilitation Center under the Ministry of Health of Russian Federation, Moscow, Russian Federation, 16<\/sup>Oncology, Merck & Co., Inc., Kenilworth, United States of America, 17<\/sup>Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, United States of America<\/p>\n

Background:<\/strong> Pembrolizumab (pembro) shows efficacy in patients (pts) with previously treated, PD-L1\u2013positive advanced cervical cancer. In KEYNOTE-826 (NCT03635567), we evaluated the efficacy and safety of pembro + chemotherapy (chemo) \u00b1 bevacizumab (bev) for recurrent, persistent, or metastatic cervical cancer.<\/p>\n

Methods:<\/strong> 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 \u226435 cycles added to chemo (paclitaxel + cisplatin or carboplatin) \u00b1 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 \u22651, all-comer, and CPS \u226510 populations. All data are from the protocol-specified first interim analysis (May 3, 2021 data cutoff).<\/p>\n

Results:<\/strong> 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 \u22651 and 317 (51.4%) had CPS \u226510. Pembro + chemo significantly improved PFS and OS in the CPS \u22651, all-comer, and CPS \u226510 populations (Table). The pembro + chemo benefit was seen regardless of bev use. Grade \u22653 AE incidence was 81.8% in the pembro + chemo arm and 75.1% in the placebo + chemo arm. The most common grade \u22653 AEs were anemia (30.3% vs 26.9%) and neutropenia (12.4% vs 9.7%).<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\n\n

PD-L1 CPS \u22651<\/strong><\/p>\n<\/td>\n

\n

All-Comer<\/strong><\/p>\n<\/td>\n

\n

PD-L1 CPS \u226510<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Pembro + Chemo<\/strong>
 (N = 273)<\/strong><\/p>\n<\/td>\n

\n

Placebo + Chemo<\/strong>
 (N = 275)<\/strong><\/p>\n<\/td>\n

\n

Pembro + Chemo<\/strong>
 (N = 308)<\/strong><\/p>\n<\/td>\n

\n

Placebo + Chemo<\/strong>
 (N = 309)<\/strong><\/p>\n<\/td>\n

\n

Pembro + Chemo<\/strong>
 (N = 158)<\/strong><\/p>\n<\/td>\n

\n

Placebo + Chemo<\/strong>
 (N = 159)<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

PFS per RECIST v1.1 by investigator review<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Median, mo<\/p>\n<\/td>\n

\n

10.4<\/p>\n<\/td>\n

\n

8.2<\/p>\n<\/td>\n

\n

10.4<\/p>\n<\/td>\n

\n

8.2<\/p>\n<\/td>\n

\n

10.4<\/p>\n<\/td>\n

\n

8.1<\/p>\n<\/td>\n<\/tr>\n

\n

12-mo rate, %<\/p>\n<\/td>\n

\n

45.5<\/p>\n<\/td>\n

\n

34.1<\/p>\n<\/td>\n

\n

44.7<\/p>\n<\/td>\n

\n

33.5<\/p>\n<\/td>\n

\n

44.6<\/p>\n<\/td>\n

\n

33.5<\/p>\n<\/td>\n<\/tr>\n

\n

HR (95% CI)<\/p>\n<\/td>\n

\n

0.62 (0.50-0.77);
 P<\/em> < 0.001<\/p>\n<\/td>\n

\n

0.65 (0.53-0.79);
 P<\/em> < 0.001<\/p>\n<\/td>\n

\n

0.58 (0.44-0.77);
 P<\/em> < 0.001<\/p>\n<\/td>\n<\/tr>\n

\n

OS<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Median, mo<\/p>\n<\/td>\n

\n

NR<\/p>\n<\/td>\n

\n

16.3<\/p>\n<\/td>\n

\n

24.4<\/p>\n<\/td>\n

\n

16.5<\/p>\n<\/td>\n

\n

NR<\/p>\n<\/td>\n

\n

16.4<\/p>\n<\/td>\n<\/tr>\n

\n

24-mo rate, %<\/p>\n<\/td>\n

\n

53.0<\/p>\n<\/td>\n

\n

41.7<\/p>\n<\/td>\n

\n

50.4<\/p>\n<\/td>\n

\n

40.4<\/p>\n<\/td>\n

\n

54.4<\/p>\n<\/td>\n

\n

44.6<\/p>\n<\/td>\n<\/tr>\n

\n

HR (95% CI)<\/p>\n<\/td>\n

\n

0.64 (0.50-0.81);
 P<\/em> < 0.001<\/p>\n<\/td>\n

\n

0.67 (0.54-0.84);
 P<\/em> < 0.001<\/p>\n<\/td>\n

\n

0.61 (0.44-0.84);
 P<\/em> = 0.001<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

Conclusions:<\/strong> 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 \u00b1 bev may be a new standard of care for this population.<\/p>\n

Clinical trial identification:<\/strong> NCT03635567.<\/p>\n

Editorial acknowledgement:<\/strong> 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.<\/p>\n

Legal entity responsible for the study:<\/strong> Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.<\/p>\n

Funding:<\/strong> Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.<\/p>\n

Disclosure: <\/strong>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. C\u00e1ceres: 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\u2019s Bureau: MSD; Financial Interests, Personal, Speaker\u2019s Bureau: AstraZeneca; Financial Interests, Personal, Speaker\u2019s Bureau: Tesaro; Financial Interests, Personal, Speaker\u2019s Bureau: Clovis; Financial Interests, Personal, Speaker\u2019s Bureau: Eisai.
P. Salman: Financial Interests, Institutional, Principal Investigator: MSD.
E. Hoyos: Financial Interests, Institutional, Funding: MSD.
E. Ya\u00f1ez: 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. Samou\u00eblian: 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.<\/p>\n<\/div>\n

Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"

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. C\u00e1ceres4, K. Hasegawa5, R. Shapira-Frommer6, K.S. Tewari7, P. Salman8, E. Hoyos9, E. Ya\u00f1ez10, M. Gumus11, M. Olivera Hurtado de Mendoza12, V. Samou\u00eblian13, V. Castonguay14, A. Arkhipov15, […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-27453","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27453","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=27453"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27453\/revisions"}],"predecessor-version":[{"id":43614,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27453\/revisions\/43614"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=27453"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=27453"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=27453"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}