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Mini oral session - Gynaecological cancers

723MO - Tisotumab vedotin (TV) + carboplatin (Carbo) in first-line (1L) or + pembrolizumab (Pembro) in previously treated (2L/3L) recurrent or metastatic cervical cancer (r/mCC): Interim results of ENGOT-Cx8/GOG-3024/innovaTV 205 study

Date

19 Sep 2021

Session

Mini oral session - Gynaecological cancers

Presenters

Ignace Vergote

Citation

Annals of Oncology (2021) 32 (suppl_5): S725-S772. 10.1016/annonc/annonc703

Authors

I.B. Vergote1, B.J. Monk2, R.E. O’Cearbhaill3, A.M. Westermann4, S. Banerjee5, D.C. Collins6, M.R. Mirza7, D. O'Malley8, C. Gennigens9, S. Pignata10, B. Melichar11, A. Sadozye12, F. Forget13, K.S. Tewari14, E. Gort15, I. Soumaoro16, C. Mondrup Andreassen17, L.V. Nicacio18, E. Van Nieuwenhuysen1, D. Lorusso19

Author affiliations

  • 1 Gynecologic Oncology, Belgium and Luxembourg Gynaecological Oncology Group, University of Leuven, Leuven Cancer Institute, 3000 - Leuven/BE
  • 2 Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, 85284 - Phoenix/US
  • 3 Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 10065 - New York/US
  • 4 Medical Oncology, Academisch Medisch Centrum, 1105AZ - Amsterdam/NL
  • 5 Gynecology, The Royal Marsden NHS Foundation Trust, SW3 6JJ - London/GB
  • 6 Medical Oncology, Cork University Hospital/Oncology Trials Unit, 0000 - Cork/IE
  • 7 Oncology, Rigshospitalet Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 8 Gynecologic Oncology, Department of Gynecology and Obstetrics, The Ohio State University College of Medicine, 43210 - Columbus/US
  • 9 Medical Oncology, Centre Hospitalier Universitaire de Liege, 4000 - Liège/BE
  • 10 Urology And Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, 80131 - Naples/IT
  • 11 Medical Oncology, Palacký University Medical School and Teaching Hospital, 77900 - Olomouc/CZ
  • 12 Medical Oncology, NHS Greater Glasgow and Clyde, G12 0YN - Glasgow/GB
  • 13 Medical Oncology, Centre Hospitalier de l'Ardenne, 6800 - Libramont/BE
  • 14 Obstetrics & Gynecology, University of California, Irvine Medical Center, 92868 - Orange/US
  • 15 Medical Oncology, University Medical Center Utrecht, 3584 CX - Utrecht/NL
  • 16 Medical Oncology, Genmab US, Inc., 08540 - Princeton/US
  • 17 Biostatistics, Genmab A/S, 1560 - Copenhagen/DK
  • 18 Medical Affairs, Seagen, Inc., 98021 - Bothell/US
  • 19 Gynecologic Oncology, Fondazione IRCCS, Foundation Policlinico Universitario Agostino Gemelli IRCCS, 00168 - Rome/IT
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Resources

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Abstract 723MO

Background

TV demonstrated durable activity (objective response rate [ORR]=24%; median duration of response [mDOR]=8.3 mo) with manageable safety in previously treated r/mCC (Lancet Oncol. 2021; 22:609-619). Here we report results for the 1L TV + carbo and 2L/3L TV + pembro cohorts of the 2-part, multi-cohort phase Ib/II trial ENGOT-cx8/GOG-3024/innovaTV 205 clinical trial in r/mCC.

Methods

In the 1L TV + carbo cohort, pts with no prior systemic therapy (excluding chemoradiation) for r/mCC received TV 2.0 mg/kg + carbo AUC 5 IV every 3 weeks (Q3W). In the 2L/3L TV + pembro cohort, pts with r/mCC, with disease progression on/after 1–2 prior systemic therapies, received TV 2.0 mg/kg + pembro 200 mg IV Q3W. The primary endpoint was ORR per RECIST v1.1.

Results

There were 33 pts treated with 1L TV + carbo (median 5 cycles). Confirmed ORR was 55% (Table). All treated pts had adverse events (AEs) with 76% reporting grade (gr) ≥3 AEs regardless of causality. Prespecified AEs of interest (gr 1-2/ gr ≥3) included ocular (55%/3%), peripheral neuropathy (27%/12%) and bleeding events (48%/6%). There were 35 pts treated with 2L/3L TV + pembro (median 6 cycles), with most having received 1 prior systemic treatment for r/mCC (57%) and prior bevacizumab (57%). Confirmed ORR was 35% (Table). All treated pts had AEs with 74% reporting gr ≥3 AEs regardless of causality. AEs of interest included (gr 1-2/ gr ≥3) ocular (51%/3%), peripheral neuropathy (37%/3%) and bleeding events (54%/9%). There were no treatment-related deaths in either cohort.

Conclusions

Both 1L TV + carbo and 2L/3L TV + pembro had encouraging antitumor activity with acceptable safety profiles in pts with r/mCC. Table: 723MO

Summary of efficacy

Parameters 1L TV + Carbo (N = 33) Median FU: 4.8 months 2L/3L TV + Pembro (N = 34)a Median FU: 10.2 months
Objective response rate, n (%) [95% CI]Complete response, n (%)Partial response, n (%) 18 (55) [36–72]2 (6)16 (48) 12 (35) [20–54]2 (6)10 (29)
Median duration of response, months (range) 5.6 (2.7-NE) NE
Median time to response, months (range) 1.4 (1.1–4.4) 1.4 (1.3–5.8)
Median PFS, months (range) 6.9 (3.9–NE) 5.6 (2.7–9.6)

NE, not estimable. a1 pt was excluded from the full analysis set as they didn’t have any target or non-target lesions at baseline. Response ongoing in 13/18 pts with 1L TV + carbo and 8/12 pts with 2L/3L TV + pembro.

Clinical trial identification

NCT03786081.

Editorial acknowledgement

Editorial assistance was provided by Jerome Sah, PhD (ApotheCom, Yardley, PA, USA), and funded by Genmab A/S.

Legal entity responsible for the study

Genmab A/S and Seagen Inc.

Funding

Genmab A/S.

Disclosure

I.B. Vergote: Financial Interests, Institutional, Advisory Role, Consultancy fees: Clovis Oncology, Carrick Therapeutics, Deciphera Pharmaceuticals, Elevar Therapeutics, Genmab, Amgen, Millennium Pharmaceuticals, Octimet Oncology, Verastem Oncology; Financial Interests, Personal and Institutional, Advisory Role, Consultancy fees: AstraZeneca, F. Hoffmann-La Roche Ltd, GSK, Immunogen, MSD, Novocure, Oncoinvent, Sotio; Financial Interests, Personal, Advisory Role: Elevar Therapeutics; Financial Interests, Personal, Advisory Role: Jazz Pharma, Mersana, Zentalis; Financial Interests, Institutional, Research Grant, via KULeuven: Oncoinvent, Genmab; Financial Interests, Personal, Research Grant: Amgen, Roche; Financial Interests, Personal, Other, Accommodations/travel expenses: Amgen, MSD, Tesaro, AstraZeneca, Roche. B.J. Monk: Financial Interests, Personal, Advisory Role: Agenus, Akeso Bio, Aravive, AstraZeneca, Clovis, Eisai, Elevar, Genmab/Seagen, GOG Foundation, Gradalis, ImmunoGen, Karyopharm, Iovance, Merck, McKesson, Mersana, Novocure, Myriad, Pfizer, Puma, Roche/Genentech, Sorrento, Tesaro/GSK, VBL; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, Tesaro/GSK. R.E. O’Cearbhaill: Financial Interests, Personal, Other, Honoraria: GlaxoSmithKline; Financial Interests, Personal, Advisory Role: Regeneron, Seagen; Financial Interests, Institutional, Research Grant: Bayer/Celgene/Juno, Tesaro/GSK, Ludwig Cancer Institute, Abbvie/StemCentrx, Regeneron, TCR2 Therapeutics, Atara Biotherapeutics, MarkerTherapeutics, Syndax Pharmaceuticals, Genmab Therapeutics, Sellas Therapeutics, Genentech, Kite Pharma, Gynecologic Onco; Financial Interests, Personal, Other, Meal: AstraZeneca; Non-Financial Interests, Personal, Other, Non-compensated steering committee member for the PRIMA, Moonstone (Tesaro/GSK) and DUO-O (AstraZeneca) studies. S. Banerjee: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Amgen, Clovis, Genmab, Immunogen, Mersana, MSD, Merck Sereno, OncXerna, Pfizer, Roche; Financial Interests, Personal, Other, PI-pharma sponsored clinical trial: Verastem; Financial Interests, Institutional, Research Grant: AstraZeneca, Tesaro, GSK. D.C. Collins: Financial Interests, Personal, Other, Honoraria: AZD, Roche, Pfizer, Amgen, Takeda, Genmab; Financial Interests, Personal, Advisory Role: Genmab, Pfizer, MSD; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Other, Travel/accommodations/expenses: Roche. M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zailab; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK; Financial Interests, Personal, Member of the Board of Directors: Karyopharm; Financial Interests, Personal, Stocks/Shares: Karyopharm; Non-Financial Interests, Institutional, Research Grant: Apexigen; Non-Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Institutional, Other, Trial chair: Deciphera; Non-Financial Interests, Institutional, Research Grant: GSK, Ultimovacs. D. O'Malley: Financial Interests, Personal, Advisory Role: AstraZeneca, Tesaro/GSK, Immunogen, Ambry, Janssen/J&J, BBI, Agenus, AbbVie, Regeneron, Amgen, Novocure, Genentech/Roche, GOGFoundation, Iovance Biotherapeutics, Inc, Myriad Genetics, Eisai, Agenus, Tarveda, Merck, SeaGen, Novartis, Mersana, Clovis, Rubi; Financial Interests, Institutional, Research Grant: AstraZeneca, Tesaro/GSK, Immunogen, Janssen/J&J, AbbVie, Regeneron, Amgen, Novocure, Genentech/Roche, VentiRx, Array Biopharma, EMD Serono, Ergomed, Ajinomoto Inc., Ludwig Cancer Research Stemcentrx, Inc, Cerulean Pharma, GOGFoundation, NCI, Bristol Myer. S. Pignata: Financial Interests, Personal, Other, Honoraria: Roche, AstraZeneca, MSD, Clovis, GSK; Financial Interests, Institutional, Research Grant: Roche, MSD, Pfizer, AstraZeneca. B. Melichar: Financial Interests, Personal, Other, Honoraria: Roche, Pfizer, BMS, Astellas, Novartis, Bayer, MSD, Merck Serono, Sanofi, Servier, AstraZeneca, Amgen, Janssen, Eisai, E. Lilly, Pierre Fabre; Financial Interests, Personal, Advisory Role: Roche, Pfizer, BMS, Astellas, Novartis, Bayer, MSD, Merck Serono, Sanofi, Servier, AstraZeneca, Amgen, Janssen, Eisai, E. Lilly, Pierre Fabre; Financial Interests, Personal, Other, Travel/accommodations/expenses: Merck, Serono, BMS. K.S. Tewari: Financial Interests, Institutional, Advisory Role: Genentech, Regeneron, AbbVie, Merck; Financial Interests, Personal, Advisory Role: Genentech, Merck, Instil Bio, Eisai, AstraZeneca, Clovis, GSK/Tesaro, AbbVie; Financial Interests, Personal, Speaker’s Bureau, Speaker bureau/expert testimony: Merck, Eisai, AstraZeneca, GSK/Tesaro, Clovis; Financial Interests, Personal, Leadership Role, DSMB Chair – Iovance study on TILs: Iovance. I. Soumaoro: Financial Interests, Personal, Full or part-time Employment: Genmab. C. Mondrup Andreassen: Financial Interests, Personal, Full or part-time Employment: Genmab A/S; Financial Interests, Personal, Stocks/Shares: Genmab A/S. L.V. Nicacio: Financial Interests, Personal, Full or part-time Employment: Seagen; Financial Interests, Personal, Other, Travel/accommodations/expenses: Seagen. D. Lorusso: Financial Interests, Personal, Other, Honoraria: MSD, ImmunoGen, Genmab, AstraZeneca, Merck Serono, Clovis, Pharmamar, GSK; Financial Interests, Personal, Advisory Role: Merck Serono, Pharmamar; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Expert Testimony: Clovis; Financial Interests, Institutional, Research Grant: MSD, Clovis, GSK, Pharmamar; Financial Interests, Personal, Other, Travel/accommodations/expenses: Pharmamar, GSK, AstraZeneca, Roche; Financial Interests, Personal, Member of the Board of Directors: GCIG, MITO Group, Engot. All other authors have declared no conflicts of interest.

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