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Clinical Studies

Efficacy and safety of rucaparib treatment in patients with BRCA-mutated, relapsed ovarian cancer: final results from Study 10

British Journal of Cancer volume 128, pages 255–265 (2023)Cite this article

Subjects

Abstract

Background

Study 10, a four-part Phase 1/2 study, evaluated oral rucaparib monotherapy in patients with advanced solid tumours. Here we report the final efficacy and safety results in heavily pretreated patients with ovarian cancer who received rucaparib in Study 10 Parts 2A and 2B.

Methods

Parts 2A and 2B (Phase 2 portions) enrolled patients with relapsed, high-grade, platinum-sensitive or platinum-resistant, BRCA-mutated ovarian cancer who had received 2–4 (Part 2A) or 3–4 (Part 2B) prior chemotherapies. Patients received oral rucaparib 600 mg twice daily (starting dose). The primary endpoint was the investigator-assessed objective response rate (ORR) by RECIST v1.1.

Results

Fifty-four patients were enrolled: 42 in Part 2A (all had platinum-sensitive disease) and 12 in Part 2B (4 with platinum-sensitive disease; 8 with platinum-resistant disease). ORR was 59.3% (95% CI 45.0–72.4%). The median time to onset of the most common nonhaematological treatment-emergent adverse events (TEAEs) was typically early (<56 days) and was later for haematological TEAEs (53–84 days). The median duration of grade ≥3 TEAEs was ≤13 days.

Conclusions

In patients with relapsed, platinum-sensitive or platinum-resistant germline BRCA-mutant high-grade ovarian cancer who had received ≥2 prior chemotherapies, rucaparib had robust antitumour activity with a safety profile consistent with prior reports.

Clinical trial registration

NCT01482715.

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Fig. 1: Response to rucaparib according to RECIST (N = 54).
Fig. 2: Median time to first onset and median duration of first TEAE.
Fig. 3: Prevalence of most common nonhaematological and haematological TEAEs by treatment month.
Fig. 4: Examples of individual patient laboratory values according to the rucaparib dose received.

Data availability

Consent was not obtained from patients to allow the posting of the data to public repositories. Requests for de-identified datasets for the results reported in this publication will be made available to qualified researchers following the submission of a methodologically sound proposal to medinfo@clovisoncology.com. Data will be made available for such requests following the online publication of this article and for 1 year thereafter in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization. Data will be provided by Clovis Oncology. The redacted protocol for the Study 10 clinical study is available on https://clinicaltrials.gov/ProvidedDocs/15/NCT01482715/Prot_000.pdf. Clovis Oncology does not share identified participant data or a data dictionary.

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Acknowledgements

Medical writing and editorial support were funded by Clovis Oncology, Inc., and were provided by Nathan Yardley and Stephen Bublitz of Ashfield MedComms, an Inizio company.

Funding

This study was funded by Clovis Oncology, Inc. (Boulder, USA).

Author information

Author notes

  1. Rebecca S. Kristeleit

    Present address: Department of Oncology, Guy’s and St Thomas’ NHS Foundation Trust, Great Maze Pond, London, UK

  2. Yvette Drew

    Present address: BC Cancer Centre, Vancouver, BC, Canada

Authors and Affiliations

  1. UCL Cancer Institute, University College London, London, UK

    Rebecca S. Kristeleit

  2. Northern Centre for Cancer Care, Newcastle Hospitals NHS Foundation and Newcastle University, Newcastle Upon Tyne, UK

    Yvette Drew

  3. Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada

    Amit M. Oza

  4. Division of Hematology Oncology, Abramson Cancer Center, Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA, USA

    Susan M. Domchek

  5. Gynaecology Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK

    Susana Banerjee

  6. Beatson West of Scotland Cancer Center, National Health Service Greater Glasgow and Clyde and University of Glasgow, Glasgow, UK

    Rosalind M. Glasspool

  7. Scottish Gynaecological Cancer Trials Group, University of Glasgow, Glasgow, UK

    Rosalind M. Glasspool

  8. Medical Oncology, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain

    Judith Balmaña

  9. Division of Gynecologic Oncology, University of California, San Francisco, San Francisco, CA, USA

    Lee-may Chen

  10. Drug Development Unit, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA

    Manish R. Patel

  11. Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, USA

    Howard A. Burris

  12. Oncology Department, Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

    Tamar Safra

  13. Clinical Operations, Clovis Oncology, Inc., Boulder, CO, USA

    Jennifer Borrow

  14. Molecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA

    Kevin K. Lin

  15. Biostatistics, Clovis Oncology, Inc., Boulder, CO, USA

    Sandra Goble

  16. Clinical Development, Clovis Oncology, Inc., Boulder, CO, USA

    Lara Maloney

  17. Department of Oncology, Chaim Sheba Medical Center, Tel HaShomer, Israel

    Ronnie Shapira-Frommer

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  1. Rebecca S. Kristeleit
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Contributions

RSK, YD, TS, SG and LM designed the study. RSK, YD, AMO, SMD, SB, RMG, Judith Balmaña, LC, MRP, HAB, TS and RSF treated patients. RSK, YD, AMO, SMD, SB, RMG, Judith Balmaña, LC, MRP, HAB, TS, KKL and RSF acquired the data. RSK, KKL, SG and LM interpreted data. All authors wrote the manuscript and reviewed draft and final versions of it.

Corresponding author

Correspondence to Rebecca S. Kristeleit.

Ethics declarations

Competing interests

RSK has received institutional funding from Clovis Oncology for this clinical trial; reports clinical trial grants from Merck Sharp & Dohme; has served as a consultant from Basilea Pharmaceutica and Shattuck Pharma; has received honoraria from Clovis Oncology, AstraZeneca, GlaxoSmithKline, and Incyte; received travelling support from AstraZeneca, GlaxoSmithKline, and Sierra Oncology; has served on data safety monitoring boards or advisory boards for Clovis Oncology, AstraZeneca, BeiGene, Eisai, GlaxoSmithKline, Incyte, iTeos Therapeutics, PharmaMar and Roche. YD has contributed to the development of rucaparib and has received royalty payments from Newcastle University for this work; has received research funding from Clovis Oncology, AstraZeneca, Merck KGaA, and Verastem; and has received honoraria for advisory boards/speakers fees from Clovis Oncology, AstraZeneca, Genmab, GlaxoSmithKline, Merck and Tesaro. AMO reports institutional research grants from AstraZeneca; served on an advisory board (uncompensated) for GlaxoSmithKline; served on advisory boards and steering committees (uncompensated) for Clovis Oncology and AstraZeneca; served as a principal investigator on investigator-initiated trials for Clovis Oncology, AstraZeneca, and GlaxoSmithKline. SMD has received research funding from Clovis Oncology and AstraZeneca; and has received honoraria from Clovis Oncology, AstraZeneca, and Bristol Myers Squibb. SB has served on advisory boards and received honoraria from Clovis Oncology, AstraZeneca, Genmab, GlaxoSmithKline, Immunogen, Merck Serono, Merck Sharp & Dohme, Mersana, Pfizer, Roche, Seattle Genetics, and Tesaro; received honoraria for lectures from AstraZeneca/Merck Sharp & Dohme, GlaxoSmithKline, Pfizer, Roche, and Tesaro; received support for travel or accommodation from NuCana and Tesaro; and reports institutional funding from AstraZeneca, GlaxoSmithKline and Tesaro. RMG reports grant funding for investigator-initiated studies from Clovis Oncology, Boehringer Ingelheim and Lilly/Ignyta; institutional fees from Novartis; institutional drug donation from GSK; personal fees from Clovis Oncology, AstraZeneca, and GlaxoSmithKline/Tesaro, Immunogen, Merck Sharp & Dohme and Sotio; and conference registration fees from GSK. Judith Balmaña has served on advisory boards for Clovis Oncology, AstraZeneca, and Bristol Myers Squibb; and has received support for travel from AstraZeneca. L-mC has received institutional funding from Clovis Oncology, AstraZeneca, Genentech, and GlaxoSmithKline/Tesaro for this clinical trial and others. MRP reports a leadership position with ION Pharma; has received honoraria from Adaptive Biotechnologies, Bayer, Genentech, Janssen Oncology, Pfizer, and Pharmacyclics; has served in a consulting or advisory role for Pharmacyclics/Janssen and Pfizer/EMD Serono; has served on speakers’ bureaus for Celgene, Exelixis, Genentech/Roche, and Taiho Pharmaceutical; his institution has received research funding from Clovis Oncology, Acerta Pharma, ADC Therapeutics, Agenus, Aileron Therapeutics, Artios, AstraZeneca, Bayer, Bicycle Therapeutics, BioNTech AG, BioTheryX, Black Diamond Therapeutics, Boehringer Ingelheim, Calithera Biosciences, Celgene, Checkpoint Therapeutics, CicloMed, Curis, Cyteir Therapeutics, Daiichi Sankyo, eFFECTOR Therapeutics, EMD Serono, Erasca, Evelo Biosciences, Forma Therapeutics, Genetec/Roche, Gilead Sciences, GlaxoSmithKline, H3 Biomedicine, Hengrui Therapeutics, Hutchison MediPharma, IgM Biosciences, Ignyta, Incyte, Jacobio Pharmaceuticals, Janssen, Jounce Therapeutics, Klus Pharma, Kymab, Lilly, Loxo Oncology, LSK BioPartners, Lycera, Mabspace, MacroGenics, Merck, Millennium, Mirati Therapeutics, Moderna Therapeutics, NGM Biopharmaceuticals, Novartis, Nurix, ORIC, Pfizer, Phoenix Molecular Designs, Placon, Portola Pharmaceuticals, Prelude Therapeutics, Puget Sound Biotherapeutics, PureTech, QiLu Pharmaceutical, Relay Therapeutics, Revolution Medicines, Ribon Therapeutics, Samumed, Seven and Eight Biopharmaceuticals, Silicon Therapeutics, Stemline Therapeutics, Syndax, Synthorx, Taiho Pharmaceutical, Takeda, TeneoBio, Tesaro, TopAlliance BioSciences, Treadwell Therapeutics, Vedanta Biosciences, Verastem Oncology, Vigeo, Xencor, and Zymeworks. HAB reports payment for consulting services from AstraZeneca, Celgene, Forma Therapeutics, and Incyte; has received payment for his expert testimony from Novartis; has performed noncompensated consulting services for Bayer, Daiichi Sankyo, GRAIL, Novartis, and Pfizer; and his institution has received grants for conduct of clinical trials from Clovis Oncology, Agios, Arch, Array BioPharma, Arvinas, AstraZeneca, Bayer, BIND Therapeutics, BioAtla, BioMed Valley Discoveries, Boehringer Ingelheim, Bristol Myers Squibb, CicloMed, CytomX Therapeutics, eFFECTOR Therapeutics, Foundation Medicine, Gilead Sciences, GlaxoSmithKline, Harpoon Therapeutics, Incyte, Janssen, Jounce Therapeutics, Kyocera, Lilly, Macrogenics, MedImmune, Merck, miRNA Therapeutics, Moderna Therapeutics, Novartis, Pfizer, Revolution Medicines, Roche/Genentech, Seattle Genetics, Takeda/Millennium, Tesaro, TG Therapeutics, Verastem, and Vertex. Dr. Burris is employed by and has a leadership position at HCA Healthcare/Sarah Cannon Research Institute and owns stock in that company. TS declares no conflict of interest. Jennifer Borrow, KKL, SG and LM are employees of Clovis Oncology and may own stock or have stock options in that company. RS-F has received research grants from Merck Sharp & Dohme; and has received speaker honoraria from AstraZeneca, Bristol Myers Squibb, Medison, Merck Sharp & Dohme, Neopharm and Novartis.

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The study was approved by an institutional review board at each study site and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines of the International Council for Harmonisation.

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Kristeleit, R.S., Drew, Y., Oza, A.M. et al. Efficacy and safety of rucaparib treatment in patients with BRCA-mutated, relapsed ovarian cancer: final results from Study 10. Br J Cancer 128, 255–265 (2023). https://doi.org/10.1038/s41416-022-02022-y

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