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Proffered Paper - Gynaecological cancers 2

LBA31 - Primary results from IMagyn050/GOG 3015/ENGOT-OV39, a double-blind placebo (pbo)-controlled randomised phase III trial of bevacizumab (bev)-containing therapy +/- atezolizumab (atezo) for newly diagnosed stage III/IV ovarian cancer (OC)

Date

21 Sep 2020

Session

Proffered Paper - Gynaecological cancers 2

Presenters

Kathleen Moore

Citation

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

Authors

K.N. Moore1, M. Bookman2, J. Sehouli3, A. Miller4, C. Anderson5, G. Scambia6, T. Myers7, C. Taskiran8, K. Robison9, J. Maenpaa10, L.J. Willmott11, N. Colombo12, J. Thomes-Pepin13, M.A. Gold14, C. Aghajanian15, F. Wu16, L. Molinero17, V. Khor18, Y.G. Lin18, S. Pignata19

Author affiliations

  • 1 Department Of Obstetrics And Gynecology, Stephenson Cancer Center at the University of Oklahoma, 73104 - Oklahoma City/US
  • 2 Gynecologic Oncology, Kaiser Permanente Northern California, San Francisco/US
  • 3 Department Of Gynecology With Center For Oncological Surgery, Charité-Medical University of Berlin (Campus Virchow Klinikum), 13353 - Berlin/DE
  • 4 Department Of Biostatistics And Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo/US
  • 5 Gynecologic Oncology, Willamette Valley Cancer Institute, Eugene/US
  • 6 Department Of Obstetrics And Gynaecology, Fondazione Policlinico Universitario Gemelli IRCCS, 00168 - Roma/IT
  • 7 Division Of Gynecologic Oncology, Baystate Medical Center, Springfield/US
  • 8 Department Of Obstetrics And Gynecology, Division Of Gynecologic Oncology, Koc University School of Medicine and VKV American Hospital, 34365 - Istanbul/TR
  • 9 Gynecologic Oncology, Women and Infants Hospital, Providence/US
  • 10 Department Of Obstetrics And Gynecology, Tampere University and University Hospital, 33521 - Tampere/FI
  • 11 Gynecologic Oncology, Arizona Oncology Associates, PC, 85016 - Phoenix/US
  • 12 Department Of Medicine And Surgery, European Institute of Oncology, IRCCS, and University of Milan-Bicocca, 20141 - Milan/IT
  • 13 Gynecologic Oncology, Minnesota Oncology, Maplewood/US
  • 14 Department Of Obstetrics And Gynecology, Oklahoma Cancer Specialists, Tulsa/US
  • 15 Gynecologic Medical Oncology Service, Weill Cornell Medical College, New York/US
  • 16 Biostatistics, Biometrics, Genentech, Inc., South San Francisco/US
  • 17 Oncology Biomarker Development, Genentech, Inc., South San Francisco/US
  • 18 Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 19 Department Of Urology And Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, 80131 - Napoli/IT
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Resources

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Abstract LBA31

Background

Atezo, which targets PD-L1, is effective in several cancers. Blocking tumour-associated VEGF may promote T-cell infiltration into the tumour bed and boost anti-tumour immune response, justifying combination with bev. Dual VEGF-A and PD-L1 blockade is effective in lung and hepatocellular cancers.

Methods

IMagyn050 (NCT03038100) enrolled patients (pts) with newly diagnosed untreated stage III/IV OC who underwent either primary cytoreductive surgery (PCS) with gross residual disease or neoadjuvant chemotherapy (NACT) and interval surgery. Eligible pts were randomised 1:1 to atezo 1200 mg or pbo cycles 1–22, with paclitaxel 175 mg/m2 + carboplatin AUC6 cycles 1–6 + bev 15 mg/kg cycles 2–22 (PCS pts), omitting peri-operative bev in NACT pts. Cycles were repeated q3w. Stratification factors were: stage (III vs IV), ECOG PS (0 vs 1/2), PD-L1 staining in immune cells (IC <1% vs ≥1% [PD-L1+]) and treatment strategy (PCS vs NACT). The co-primary endpoints were investigator-assessed progression-free survival (PFS; RECIST v1.1) and overall survival (OS) in the intent-to-treat (ITT) and PD-L1+ populations. PFS was tested in parallel in the two populations; OS was tested hierarchically.

Results

Of 1301 enrolled pts, ∼25% received NACT. At the data cut-off (30 Mar 2020) median follow-up was ∼20 months in both arms. There was no statistically significant PFS improvement in either the ITT population (HR 0.92 [95% CI 0.79–1.07]; median 18.4 months with pbo vs 19.5 months with atezo) or the PD-L1+ population (HR 0.80 [0.65–0.99], median 18.5 vs 20.8 months, respectively). Exploratory PFS analyses in the PD-L1 IC ≥5% subgroup showed a trend favouring atezo. Though immature, first interim OS results did not show significant benefit from atezo. Similar proportions discontinued any study treatment for AEs (22% pbo vs 26% atezo pts). The safety profile of atezo + bev + chemotherapy was consistent with expected AEs.

Conclusions

Atezo did not significantly improve PFS in the ITT or PD-L1+ population. The combination was generally well tolerated with manageable AEs. Exploratory biomarker subgroup analyses are ongoing.

Clinical trial identification

NCT03038100.

Editorial acknowledgement

Jennifer Kelly (Medi-Kelsey Ltd), funded by F Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

K.N. Moore: Advisory/Consultancy: Aravive; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Clovis; Advisory/Consultancy: Eisai; Advisory/Consultancy, Research grant/Funding (institution): GSK/Tesaro; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution): Immunogen; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy: Mersana; Advisory/Consultancy: OncoMed/Mereo; Advisory/Consultancy: VBL Therapeutics; Advisory/Consultancy: Vavotar; Advisory/Consultancy: Tarveda; Research grant/Funding (institution): PTC Therapeutics; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): OncoMed. M. Bookman: Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: AstraZeneca; Non-remunerated activity/ies, Steering Committee: Roche; Honoraria (self): AbbVie; Honoraria (self): Aravive; Honoraria (self): Mateon; Honoraria (self): Immunogen. J. Sehouli: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): PharmaMar; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Clovis; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: GSK/Tesaro; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Novocure; Advisory/Consultancy: Eisai; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Leadership role: NOGGO; Leadership role: ESGO; Leadership role: PARSGO; Leadership role: AGO; Research grant/Funding (institution): Roche Diagnostics; Research grant/Funding (institution): Medac. G. Scambia: Advisory/Consultancy: Tesaro Bio Italy S.r.l/GlaxoSmithKline; Advisory/Consultancy: Johnson & Johnson; Speaker Bureau/Expert testimony: Clovis Oncology Italy S.r.l.; Research grant/Funding (self): MSD Italia S.r.l. J. Maenpaa: Honoraria (self): AstraZeneca; Honoraria (self): Orion Pharma; Honoraria (self): Clovis; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Tesaro/GSK. L.J. Willmott: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Clovis; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Genentech; Honoraria (self), Advisory/Consultancy: GSK; Honoraria (self), Speaker Bureau/Expert testimony: Merck. N. Colombo: Honoraria (self), Travel/Accommodation/Expenses: PharmaMar; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self): GSK/Tesaro; Honoraria (self): Clovis; Honoraria (self): Immunogen; Honoraria (self): MSD; Honoraria (self): Pfizer; Honoraria (self): Biocad; Research grant/Funding (institution): Roche. C. Aghajanian: Honoraria (self), Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: Immunogen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Clovis; Honoraria (self), Advisory/Consultancy: Eisai/Merck; Honoraria (self), Advisory/Consultancy: Mersana Therapeutics; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): AstraZeneca. F. Wu: Full/Part-time employment: Genentech, Inc.; Shareholder/Stockholder/Stock options: Roche. L. Molinero: Full/Part-time employment: Genentech, Inc.; Shareholder/Stockholder/Stock options: Roche. V. Khor: Full/Part-time employment: Genentech, Inc.; Shareholder/Stockholder/Stock options: Roche. Y.G. Lin: Full/Part-time employment: Genentech, Inc.; Shareholder/Stockholder/Stock options: Roche. S. Pignata: Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self): GSK; Honoraria (self): Clovis; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): PharmaMar; Research grant/Funding (institution): Pfizer. All other authors have declared no conflicts of interest.

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