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Poster session 01

747P - SOLACE2: A phase II randomized trial of olaparib (O) and durvalumab (D) with or without low dose cyclophosphamide (LDCy) in platinum-sensitive recurrent ovarian cancer (PSROC)

Date

14 Sep 2024

Session

Poster session 01

Topics

Cancer Biology;  Tumour Immunology;  Translational Research;  Immunotherapy

Tumour Site

Ovarian Cancer

Presenters

Clare Scott

Citation

Annals of Oncology (2024) 35 (suppl_2): S544-S595. 10.1016/annonc/annonc1592

Authors

C.L. Scott1, M.L. Friedlander2, K. Francis3, A.E..R. Kartikasari4, K. Diamante3, N. Bound1, C. Davies5, R. OConnell3, Y.C. Lee3, J. Lombard6, S.E. Baron-Hay7, Y. Antill8, C. Shannon9, S. Selva-Nayagam10, P.J. Beale11, K. Shield-Artin1, M. Wakefield1, C. Vandenberg1, M. Plebanski4, C.K. Lee3

Author affiliations

  • 1 Cancer Biology And Stem Cells Division, WEHI - Walter and Eliza Hall Institute of Medical Research, 3052 - Parkville/AU
  • 2 Medical Oncology Department, Prince of Wales Hospital, 2031 - Sydney/AU
  • 3 Nhmrc Clinical Trials Centre, The University of Sydney, 2050 - Camperdown/AU
  • 4 School Of Health And Biomedical Sciences, RMIT - Royal Melbourne Institute Of Technology, 3001 - Melbourne/AU
  • 5 Tr-anzgog, Australia New Zealand Gynaecological Oncology Group (ANZGOG), 2050 - Camperdown/AU
  • 6 Medical Oncology, Newcastle Private Hospital, 2305 - New Lambton Heights/AU
  • 7 Medical Oncology Department, Royal North Shore Hospital, 2065 - St Leonards/AU
  • 8 Medical Oncology, Frankston Hospital, 3199 - Frankston/AU
  • 9 Medical Oncology, Mater Cancer Care Centre, 4101 - South Brisbane/AU
  • 10 Medical Oncology, Royal Adelaide Hospital, 5000 - Adelaide/AU
  • 11 Medical Oncology, Chris O'Brien Lifehouse, 2050 - Camperdown/AU

Resources

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Abstract 747P

Background

Preclinical data shows that T-cell priming by LDCy leads to greater responses in PSROC treated with LDCy and O compared with O alone. We hypothesized that priming with LDCy would also enhance the treatment effect of D with O.

Methods

In this non-comparative phase 2 trial, women naïve of D and O with first recurrence PSROC and asymptomatic CA125 progression were randomly assigned in 1:1:1 ratio to receive: (A) 12 weeks induction with O followed by maintenance O-D, (B) 12 weeks LDCy-O followed by maintenance O-D, and (C) O continuous therapy. The primary endpoint was progression-free survival (PFS) rate at 36 weeks (PFS36). Response according to RECIST and CA125, safety, and a novel immune signature based on tumor microenvironment were also assessed.

Results

A total of 114 patients underwent randomization. Median follow-up was 36.1 months with 89.5% progression events. PFS36 rates were 47.4% (95% CI 31.0-62.1), 48.7% (95% CI 32.5-63.2) and 35.1% (20.4-50.2) for arms (A), (B) and (C) respectively. The median PFS was 8.2, 8.3 and 5.7 months respectively. Objective responses were observed in 42.1%, 53.8% and 35.1% respectively. Table summarizes outcomes according to homologous recombinant deficiency (HRD) status. Immune signature expression was associated with longer PFS regardless of treatment arms (N=98; HR 0.31, 95% CI 0.19-0.48), including BRCA wild-type HRD ovarian cancer (N=56; HR 0.39, 95% CI 0.20-0.75). The safety profile of LDCy, O and D was consistent with previous reports, but higher rates of treatment-related adverse events occurred in arm (B) as compared with arms (A) and (C). Table: 747P

Arm A Arm B Arm C
BRCA mutation PFS36 N=3 66.7% N=5 100% N=5 80.0%
BRCA wild-type homologous recombinant deficient PFS36 N=19 57.9% N=20 45.0% N=19 26.3%
BRCA wild-type homologous recombinant proficient PFS36 N=10 40.0% N=10 40.0% N=9 22.2%

Conclusions

LDCy-O, or O alone, followed by maintenance O-D did not significantly improve PFS as compared with O continuous therapy. A previously unreported immune signature is prognostic for greater PFS with olaparib-based treatment, including within BRCA wild-type HRD ovarian cancer.

Clinical trial identification

ANZCTR: ACTRN12618000686202.

Editorial acknowledgement

Legal entity responsible for the study

The University of Sydney.

Funding

This research was conducted with support from AstraZeneca and its Group of Companies.

Disclosure

C.L. Scott: Financial Interests, Personal, Advisory Board, Scientific Advisory Board, member, Sept 2021 - current: OncologyOne; Financial Interests, Institutional, Full or part-time Employment, Laboratory Head and Head Clinical Discovery Translation, WEHI: Walter and Eliza Hall Institute of Medical Research; Financial Interests, Institutional, Full or part-time Employment, Chair, Gynaecological Cancer: University of Melbourne; Financial Interests, Institutional, Full or part-time Employment, Specialist Medical Oncologist: Peter MacCallum Cancer Centre, Melbourne Health; Financial Interests, Institutional, Royalties, Royalties via my institution Walter and Eliza Hall Institution of Medical Research: Venetoclax; Financial Interests, Institutional, Research Grant, Research grant, PI, To my laboratory, including provision of drugs for research: AstraZeneca; Financial Interests, Institutional, Funding, Research grant, PI, To my laboratory, including provision of drug: Eisai, Sierra Oncology; Financial Interests, Institutional, Other, In kind research support including provision of drug, to my laboratory: Clovis Oncology; Financial Interests, Institutional, Other, In kind research support, provision of drug, to my laboratory: Beigene; Financial Interests, Institutional, Coordinating PI, Funding of the SOLACE2 trial, Study Chair and PI, Steering committee, Chair: AstraZeneca; Financial Interests, Institutional, Coordinating PI, Provision of study drug, Eribulin, for the EPOCH trial, Study Chair: Eisai; Financial Interests, Institutional, Coordinating PI, Provision of study drug, Pembrolizumab, for the EPOCH trial, Study Chair: MSD; Financial Interests, Institutional, Steering Committee Member, EMBRACE clinical trial, AZ supplied olaparib, My role, member of the steering committee; performing translation (funds from govt grant): AstraZeneca; Financial Interests, Institutional, Funding, Research grant, To my laboratory, including provision of drug for research: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant, Research grant, PI, to my laboratory, including provision of drug: Ideaya Biosciences; Non-Financial Interests, Advisory Role, Advisory Boards, member: AstraZeneca; Non-Financial Interests, Advisory Role, Advisory Board, Member: Eisai; Non-Financial Interests, Advisory Role, Advisory Board, member: Sierra Oncology, Roche, Takeda, MSD, GSK; Non-Financial Interests, Advisory Role, Advisory Board, Chair: EpsilaBio; Non-Financial Interests, Institutional, Proprietary Information, Research collaboration, provision of drugs and discussion of commercial in confidence information: AstraZeneca, Eisai; Non-Financial Interests, Institutional, Product Samples, Research collaboration, provision of drugs: AstraZeneca, Eisai; Non-Financial Interests, Institutional, Proprietary Information, Research collaboration, provision of drugs: Boerhinger Ingelheim, Ideaya Biosciences; Non-Financial Interests, Other, Board, Chair: International Rare Cancer Initiative; Non-Financial Interests, Leadership Role, GCIG Executive Board of Directors, Member: Gynaecological Cancer InterGroup (GCIG), Director; Other, PI, funded by theAustralian Government as part of the Australian Genomic Cancer Medicine Centre (AGCMC) (OMICO).: Australian Rare Cancer Portal. M.L. Friedlander: Financial Interests, Personal, Advisory Board, /Speaker: AstraZeneca, GSK, MSD; Financial Interests, Personal, Speaker, Consultant, Advisor: Limbic; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Institutional, Research Funding: AstraZeneca, Novartis, Beigene; Non-Financial Interests, Institutional, Principal Investigator: AstraZeneca, Beigene. K. Francis: Financial Interests, Personal, Invited Speaker, Castrate sensitive metastatic prostate cancer meeting: Janssen; Financial Interests, Personal, Invited Speaker, Breast cancer meeting on management of advanced breast cancer: Gilead. N. Bound: Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, IDEAYA biosciences, Eisai Inc.. Y.C. Lee: Financial Interests, Institutional, Invited Speaker, Educational events: AstraZeneca; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Institutional, Research Grant: BeiGene. J. Lombard: Financial Interests, Personal, Advisory Board, Ad Board for durvalumab + olaparib in uterine cancer: AstraZeneca; Financial Interests, Personal, Invited Speaker, educational dinner talk June 2023: Novartis; Financial Interests, Personal, Other, registration for virtual ESMO attendance October 2023: Novartis; Financial Interests, Personal, Invited Speaker, Speaker educational dinner March 2023: Eisai; Financial Interests, Personal, Invited Speaker, educational dinner speaker: Gilead; Financial Interests, Personal, Other, payment for registartion for international virtual meeting (ASCO) June 2022: GSK. S.E. Baron-Hay: Financial Interests, Personal, Advisory Board, Participation in an advisory board: Pfizer, Eisai, Novartis, GSK; Financial Interests, Personal, Advisory Board, Participation in an advisory board Invited speaker at education meeting: AstraZeneca; Financial Interests, Personal, Invited Speaker, Talks at Gilead education meeting Development of education slide deck: Gilead. Y. Antill: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo; Financial Interests, Institutional, Research Funding: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca. C. Shannon: Financial Interests, Personal, Advisory Board: AstraZeneca, Gilead, GSK, MSD. P.J. Beale: Financial Interests, Personal, Advisory Board: GSK. K. Shield-Artin, M. Wakefield, C. Vandenberg: Financial Interests, Institutional, Research Funding: AstraZeneca, Boehringer Ingelheim, Ideaya Biosciences, Eisai Inc. M. Plebanski: Financial Interests, Institutional, Research Funding: AstraZeneca; Non-Financial Interests, Personal, Advisory Board: Ovarian Cancer Research Foundation ; Financial Interests, Institutional, Other: Smartinject. C.K. Lee: Financial Interests, Personal, Advisory Board: AstraZeneca, Amgen, Roche, Janssen, Gilead, MSD, GSK, Novartis, Merck kGA; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Amgen, Merck kGA, Novartis, Roche. All other authors have declared no conflicts of interest.

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