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Mini Oral - Gynaecological cancers 2

LBA34 - Single-agent anti-PD-1 balstilimab or in combination with anti-CTLA-4 zalifrelimab for recurrent/metastatic (R/M) cervical cancer (CC): Preliminary results of two independent phase II trials


18 Sep 2020


Mini Oral - Gynaecological cancers 2



Tumour Site

Cervical Cancer


David O'Malley


Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325


D.M. O'Malley1, A. Oaknin2, B.J. Monk3, A. Leary4, F. Selle5, J. Alexandre6, L.M. Randall7, C. Rojas8, M. Neffa9, A. Kryzhanivska10, L. Gladieff11, D. Berton12, T. Meniawy13, I. Lugowska14, I. Bondarenko15, K.N. Moore16, W.I. Ortuzar Feliu17, M. Ancukiewicz18, I. Shapiro19, I.L. Ray-Coquard20

Author affiliations

  • 1 Gynecology And Obstetrics, OSUCCC - The Ohio State University Comprehensive Cancer Center - James, 43210 - Columbus/US
  • 2 Medical Oncology, Vall d'Hebron University Hospital, 8035 - Barcelona/ES
  • 3 Gynecologic Oncology Department, Arizona Oncology (US Oncology Network), 85016 - Phoenix/US
  • 4 Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 5 Medical Oncology, Hôpital Croix Saint Simon – Diaconesses, 75020 - Paris/FR
  • 6 Medical Oncology, Université de Paris, hôpital Cochin, 75014 - Paris/FR
  • 7 Department Of Obstetrics And Gynecology, Massey Cancer Center, Virginia Commonwealth University, 23298 - Richmond/US
  • 8 Medical Oncology, Universidad de los Andes, 8420323 - Santiago/CL
  • 9 Department Of Surgery, CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection,, 61166 - Kharkiv/UA
  • 10 Medical Oncology, CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU, 76018 - Ivano-Frankivsk/UA
  • 11 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 12 Medical Oncology, Groupe d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens (GINECO), Institut de Cancérologie de l'Ouest (ICO) Centre René Gauducheau, Saint-Herblain/FR
  • 13 Medical Oncology, Linear Clinical Research, Nedlands/AU
  • 14 Medical Oncology, Maria Sklodowska-Curie Memorial Cancer Centre-Institute of Oncology, 02-781 - Warsaw/PL
  • 15 Haematology, Oncology, 4Municipal Institution City Clinical Hospital, Dnipropetrovsk Oblast/UA
  • 16 Department Of Obstetrics And Gynecology University, Stephenson Cancer Center/University of Oklahoma, 73104 - Oklahoma City/US
  • 17 Clinical Development, Agenus Inc - Corporate HQ, R&D and Vaccine Manufacturing, 2421 - Lexington/US
  • 18 Clinical Development, Agenus Inc., Lexington/US
  • 19 Global Development, agenus inc., 02421 - Lexington/US
  • 20 Medical Oncology Department, Centre Léon Bérard, 69008 - Lyon/FR


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Abstract LBA34


Second line treatment for R/M CC continues to be a high unmet clinical need. We present data from 2 ph2 trials, of single-agent balstilimab (bal) and in combination with zalifrelimab (zal) in R/M CC.


Patients received single-agent bal 3mg/kg q2w (NCT03104699) or in combination with zal 1mg/kg q6w (NCT03495882) up to 2 yrs. The primary endpoint was objective response rates (ORR) assessed per RECIST 1.1 by independent review, secondary endpoints included safety and DOR.


We treated161 & 155 pts in the bal and bal/zal, respectively with 160 & 143 pts had baseline measurable disease (modified ITT population). All pts previously received platinum-based treatment for their first line as per protocol. Squamous-cell cancer (SCC) (63% bal; 74% bal/zal) was the predominant histologic subtype with adenocarcinoma/adenosquamous/other (AC) also represented. PD-L1 positive was defined as CPS ≥ 1% (62% bal; 55% bal/zal), negative as CPS <1% (26% bal; 25% bal/zal) or unknown (12% bal; 20% bal/zal). Efficacy data are below.

Treatment was well tolerated in both trials. 49 (30%) pts had immune-related AEs in bal & 50 (35%) in bal/zal trial (all grades) and severe (Grade 3+) 13 (8.0%) and 15 (10.5%) respectively. Treatment discontinuation were seen in 22 pts (13.7%) in bal and 15 pts (10%) in bal/zal. There were no treatment related deaths on the bal trial and 2 in the bal/zal trial (nephritis; pneumonitis). No new safety signals were identified. Table: LBA34

Efficacy bal (160) N (%) bal/zal (143) N (%)
ORR 24 (14) 31 (22)
CR 3 (2) 8 (6)
PR 20 (12) 23 (16)
DOR (m) 15.4 [1.1+,15.4] NR [1.3+,16.6+]
SCC 18/100 (18) 28/106 (27)
AC 5/59 (8) 3/37 (7)
PD-L1 + 19/99 (19) 21/79 (27)
PD-L1 - 4/42 (10) 4/36 (11)
Unknown PD-L1 0/19 (0) 6/28 (21)


These results show that both single-agent bal and bal/zal are active and well tolerated in R/M CC. Adding bal to zal increased both ORR and DOR with marginal increase in AEs. Responses were more common in the PD-L1 + and SCC pts, but responses were seen in PD-L1-, AC pts. This is by far the largest reported study of checkpoint inhibitors in cervical cancer to date.

Clinical trial identification

NCT03104699, NCT03495882.

Editorial acknowledgement

Legal entity responsible for the study

Agenus Inc.


Agenus Inc.


D.M. O'Malley: Honoraria (institution): AstraZeneca; Research grant/Funding (self): Clovis; Honoraria (self): Tesaro; Honoraria (self), Honoraria (institution): Immunogen; Honoraria (self): Ambry; Honoraria (self), Honoraria (institution): Jansen/J&J; Honoraria (self), Honoraria (institution): AbbVie; Honoraria (self), Honoraria (institution): Regeneron; Honoraria (self), Honoraria (institution): Amgen; Honoraria (self), Honoraria (institution): Novocure; Honoraria (self), Honoraria (institution): Genentech/Roche; Honoraria (institution): VentiRx; Honoraria (institution): Array Biopharma; Research grant/Funding (institution): EMD Serono; Research grant/Funding (institution): Ergomed; Research grant/Funding (institution): Ajinomoto Inc.; Research grant/Funding (institution): Stemcentrx, Inc.; Research grant/Funding (institution): Cerulean Pharma; Honoraria (self), Research grant/Funding (institution): GOG Foundation; Research grant/Funding (institution): Bristol-Myers Squibb Co; Research grant/Funding (institution): Serono Inc; Research grant/Funding (institution): Tracon Pharmaceuticals; Research grant/Funding (institution): Yale University; Research grant/Funding (institution): New Mexico Cancer Care Alliance; Research grant/Funding (institution): INC Research, Inc; Research grant/Funding (institution): inVentiv Health Clinical; Research grant/Funding (institution): Iovance Biotherapeutics, Inc; Research grant/Funding (institution): PRA Int; Honoraria (self): Myriad Genetics; Honoraria (self), Research grant/Funding (institution): Esai. I.L. Ray-Coquard: Honoraria (self), Advisory/Consultancy: Agenus Inc.; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: advaxis; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Genmab; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy: Deciphera; Honoraria (self), Advisory/Consultancy: Mersena; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: Clovis. All other authors have declared no conflicts of interest.

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