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Clinical Studies

Olaparib maintenance versus placebo in platinum-sensitive non-small cell lung cancer: the Phase 2 randomized PIPSeN trial

British Journal of Cancer volume 130, pages 417–424 (2024)Cite this article

Subjects

Abstract

Background

Platinum-sensitivity is a phenotypic biomarker of Poly (ADP-ribose) polymerase inhibitors (PARPi) sensitivity in histotypes where PARPi are approved. Approximately one-third of non-small cell lung cancers (NSCLC) are platinum-sensitive. The double-blind, randomized phase II PIPSeN (NCT02679963) study evaluated olaparib, a PARPi, as maintenance therapy for patients with platinum-sensitive advanced NSCLC.

Methods

Chemonaïve patients with ECOG performance status of 0–1, platinum-sensitive, EGFR- and ALK-wild-type, stage IIIB-IV NSCLC were randomized (R) to receive either olaparib (O) maintenance or a placebo (P). The primary objective was progression-free survival (PFS) from R. Secondary objectives included overall survival (OS) and safety. With an anticipated hazard ratio of 0.65, 144 patients were required to be randomized, and approximately 500 patients enrolled.

Results

The trial was prematurely terminated because anti-PD(L)1 therapy was approved during the trial recruitment. A total of 182 patients were enrolled, with 60 patients randomized: 33 and 27 in the O and P arms, respectively. Patient and tumor characteristics were well-balanced between arms, except for alcohol intake (33% vs 11% in the O and P arms, respectively, p = 0.043). The median PFS was 2.9 and 2.0 months in the O and P arms, respectively (logrank p = 0.99). The median OS was 9.4 and 9.5 months in the O and P arms, respectively (p = 0.28). Grade ≥3 toxicities occurred in 15 and 8 patients in O and P arms, with no new safety concerns.

Conclusion

PIPSeN was terminated early after enrollment of only 50% of the pre-planned population, thus being statistically underpowered. Olaparib maintenance did neither improve median PFS nor OS in this patient population.

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Fig. 1: Study design.
Fig. 2: CONSORT diagram of PIPSeN.
Fig. 3: Treatment outcomes.

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Data availability

Original data could be made available upon request for research purposes on a case-by-case basis, in a pseudonymized way and under current GDPR policies, so that patient protection is fully ensured.

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Acknowledgements

Figure 1 has been created by Mihaela Aldea with Biorender.com. English editing was performed with ChatGPT v4.

Author information

Authors and Affiliations

  1. Drug Development Department, DITEP, Gustave Roussy, Villejuif, France

    Sophie Postel-Vinay & Anas Gazzah

  2. ERC StG group, Inserm Unit U981, Gustave Roussy, Villejuif, France

    Sophie Postel-Vinay & Anas Gazzah

  3. University College of London, Cancer Institute, London, UK

    Sophie Postel-Vinay

  4. Medical Oncology Department, Hospital Son Llátzer, Palma de Mallorca, Spain

    Juan Coves

  5. Biostatistics Department, Gustave Roussy, Villejuif, France

    Matthieu Texier

  6. Department of Medical Oncology, Thoracic tumor board and International Cancer for Thoracic Cancers (CICT), Villejuif, France

    Mihaela Aldea, Anas Gazzah, David Planchard & Benjamin Besse

  7. Medical Oncology Department, Hospital Universitario Fundación Jiménez Díaz, IIS-FJD, Madrid, Spain

    Manuel Dómine

  8. Faculty of Medicine, Paris-Saclay University, Paris, France

    David Planchard, Jean-Charles Soria & Benjamin Besse

  9. Medical Oncology Department, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain

    Ramon De Las Peñas

  10. Medical Oncology Department, Hospital Universitario Basurto, Bilbao, Spain

    Ma Angeles Sala Gonzalez

  11. Instituto Oncológico Dr. Rosell, Hospital Universitario Dexeus, Grupo Quirón Salud, Barcelona, Spain

    Santiago Viteri

  12. Medical Oncology Department, Hospital Virgen de los Lirios de Alcoy, Alcoy, Spain

    Javier Perez

  13. Medical Oncology Department, Hospital Universitario de Jaén, Jaén, Spain

    Ana Laura Ortega

  14. Institut Català d’Oncologia Badalona, Hospital Universitari Germans Trias i Pujol, Badalona; Badalona Applied Research Group in Oncology, Barcelona, Spain

    Teresa Moran

  15. Hospital General Universitario de Valencia, Medical Oncology Department; TRIAL Mixed Unit, Centro Investigación Príncipe Felipe-Fundación Investigación Hospital General Universitario de Valencia, Valencia, Spain

    Carlos Camps

  16. Medical Oncology Department, Hospital Universitario Severo Ochoa, Madrid, Spain

    Ana Lopez-Martin

  17. Medical Oncology Department, Hospital Universitario Puerta de Hierro, Universidad Autónoma Madrid, IDIPHIM, Madrid, Spain

    Mariano Provencio

  18. Medical Oncology Department, Hospital Universitario Dr. Balmis de Alicante, Alicante, Spain

    Bartomeu Massuti

  19. Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona; Translational Cancer Research Unit, Instituto Oncológico Dr Rosell, Dexeus University Hospital, Barcelona, Spain

    Rafael Rosell

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Contributions

Study design, SPV, JCS and RR; Methodology & statistics, SPV, JP, MT, JCS and RR; Investigation, patient screening and enrollment: SPV, JC, AG, MD, DP, RDLP, MASG, SV, JP, ANO, TM, CC, ALM, MP, JCS, BB, BM, RR; Writing – Original Draft: MA and SPV; Writing – Review & Editing; all co-authors; Funding Acquisition, SPV and JCS.

Corresponding author

Correspondence to Sophie Postel-Vinay.

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Competing interests

SPV and AG: Principal/sub-Investigator of Clinical Trials for Abbvie, Adaptimmune, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, Astra Zeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Celgene Corporation, Chugai Pharmaceutical Co, Cullinan-Apollo, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Forma Tharapeutics, Gamamabs, Genentech, GlaxoSmithKline, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Janssen Cilag, Janssen Research Foundation, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Lytix Biopharma As, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Millennium Pharmaceuticals, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Oxford Therapeutics, Ose Pharma, Pfizer, Pharma Mar, PEP-therapy, Pierre Fabre, Medicament, Roche, Sanofi Aventis, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Xencor. SPV: Preclinical research funding: IMCore Hoffman La-Roche; AstraZeneca for work unrelated to this manuscript; Advisory board: Daiichi-Sankyo, Amgen. MA Travel: Sandoz ; Recherche grant : Sandoz ; Advisory : Viatris. DP: Consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung; Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung; Clinical trials research as principal or co-investigator (Institutional financial interests): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo; Travel, Accommodation, Expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer. MD: MD: Consultant or Advisory Role: Astra-Zeneca, Boehringer Ingelheim, Janssen Cilag, MSD, Pfizer, Roche, Sanofi, Takeda. Speaking: Astra-Zeneca, BMS, MSD, Pfizer, Roche, Takeda. MP: MP: Consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb (BMS), Merck, Novartis, Pfizer, Travel, Accommodation, Expenses: AstraZeneca, Roche, Novartis,BMS. ALM: No conflicts of interest related to this study. Other conflicts of interest: - Consultant or advisory board: Amgen, Boehringer. Speaking: BMS, MSD, Pierre Fabre, Astra Zeneca. TM: Dr. Moran declares consulting/advisory role fees from Roche, Bristol Myers, Boeringher, Astra Zeneca, Lilly, and Research funding from Kyowa Kirin and Janssen, all of them unrelated with the present project. JCS is a full time-employee at Amgen since August 2021. He owns stock at Gritstone Bio, Relay Therapeutics and Amgen. BB: Contracted / supported research grants: Abbvie, Amgen, AstraZeneca, BeiGene, Blueprint Medicines, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cristal Therapeutics, Daiichi-Sankyo, Eli Lilly, GSK, Ignyta, IPSEN, Inivata, Janssen, Merck KGaA, MSD, Nektar, Onxeo, OSE immunotherapeutics, Pfizer, Pharma Mar, Roche-Genentech, Sanofi, Servier, Spectrum Pharmaceuticals, Takeda, Tiziana Pharma, Tolero Pharmaceuticals JCS: Personal fees outside of this work: Astex, AstraZeneca, Bayer, Blend Therapeutics, Boehringer-Ingelheim, Clovis, Eli Lilly, Gammamabs, Merus, Mission Therapeutics, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, Servier, Symphogen, Tarveda; Gritstone; AstraZeneca All other authors declare no conflicts of interest.

Ethics approval and consent to participate

PIPSeN was granted central approval by the French Regulatory Authority ANSM under the reference 150127A12, on 10 April 2015, and Ethics Committee CPP Ile de France 8 on 10 Feb 2015. In Spain, PIPSeN was approved by the Agencia Española del Medicamento y Productos Sanitarios under the reference MUH/AEC, and the EC of Hospital Germans Trias i Pujol. Each enrolled patient provided informed consent as described in the manuscript and Supplementary Materials.

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Postel-Vinay, S., Coves, J., Texier, M. et al. Olaparib maintenance versus placebo in platinum-sensitive non-small cell lung cancer: the Phase 2 randomized PIPSeN trial. Br J Cancer 130, 417–424 (2024). https://doi.org/10.1038/s41416-023-02514-5

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