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<p>SOLACE2 (ACTRN12618000686202) investigates whether 12-weeks of olaparib, or cyclophosphamide-olaparib priming, improves subsequent durvalumab-olaparib progression-free survival (PFS), and is superior to olaparib monotherapy without any priming, in platinum-sensitive recurrent ovarian cancer (n = 114). We also evaluate the utility of CUP-CC assay, an immune signature of C-C chemokine receptor type 4 up-regulation, chemokines, and cytokines. Priming with olaparib, or cyclophosphamide-olaparib, followed by durvalumab-olaparib, are both associated with longer PFS compared to olaparib monotherapy, but do not reach the pre-specified primary endpoint of 36-week trial threshold (PFS36). PFS36 rates are 47.4% (95% CI, 31.0-62.1; olaparib priming then olaparib-durvalumab), 48.7% (32.5-63.2; olaparib-cyclophosphamide then olaparib-durvalumab) and 35.1% (20.4-50.3; olaparib monotherapy). PFS is significantly longer for the homologous recombination deficient (N = 71) as compared to the proficient (HRP) (N = 29) subgroups (Hazard Ratio (HR) 0.55, 0.35-0.87). CUP-CC+ subgroup (N = 58) has a significantly longer PFS (HR 0.31, 0.19-0.49) than CUP-CC- (N = 46). Future studies should investigate whether CUP-CC has the potential to personalize poly (ADP-ribose) polymerase inhibitor therapies for patients who are <i>BRCA</i> wild-type, including HRP patients.</p>

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Olaparib, durvalumab, and cyclophosphamide, and a prognostic blood signature in platinum-sensitive ovarian cancer: the randomized phase 2 SOLACE2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月5日

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  • Chee Khoon Lee,
  • Apriliana E. R. Kartikasari,
  • Nirashaa T. Bound,
  • Katherine E. Francis,
  • Kristy Shield-Artin,
  • Justin Bedo,
  • Ksenija Nesic,
  • Katrina Diamante,
  • Rachel L. O’Connell,
  • Mutsa Madondo,
  • Momodou Cox,
  • Claire Davies,
  • Cyril Deceneux,
  • Georgia Goodchild,
  • Andrew Jarratt,
  • Emily Cassar,
  • Hina Amer,
  • U. G. Imalki U. Kariyawasam,
  • Yeh Chen Lee,
  • Janine Lombard,
  • Sally Baron-Hay,
  • Yoland Antill,
  • Catherine Shannon,
  • Sudarshan Selva-Nayagam,
  • Philip Beale,
  • Danka Zebic,
  • Sandy Simon,
  • Anneliese Linaker,
  • Michael A. Quinn,
  • Anthony T. Papenfuss,
  • Matthew J. Wakefield,
  • Cassandra J. Vandenberg,
  • Michael Friedlander,
  • Clare L. Scott,
  • Magdalena Plebanski

摘要

SOLACE2 (ACTRN12618000686202) investigates whether 12-weeks of olaparib, or cyclophosphamide-olaparib priming, improves subsequent durvalumab-olaparib progression-free survival (PFS), and is superior to olaparib monotherapy without any priming, in platinum-sensitive recurrent ovarian cancer (n = 114). We also evaluate the utility of CUP-CC assay, an immune signature of C-C chemokine receptor type 4 up-regulation, chemokines, and cytokines. Priming with olaparib, or cyclophosphamide-olaparib, followed by durvalumab-olaparib, are both associated with longer PFS compared to olaparib monotherapy, but do not reach the pre-specified primary endpoint of 36-week trial threshold (PFS36). PFS36 rates are 47.4% (95% CI, 31.0-62.1; olaparib priming then olaparib-durvalumab), 48.7% (32.5-63.2; olaparib-cyclophosphamide then olaparib-durvalumab) and 35.1% (20.4-50.3; olaparib monotherapy). PFS is significantly longer for the homologous recombination deficient (N = 71) as compared to the proficient (HRP) (N = 29) subgroups (Hazard Ratio (HR) 0.55, 0.35-0.87). CUP-CC+ subgroup (N = 58) has a significantly longer PFS (HR 0.31, 0.19-0.49) than CUP-CC- (N = 46). Future studies should investigate whether CUP-CC has the potential to personalize poly (ADP-ribose) polymerase inhibitor therapies for patients who are BRCA wild-type, including HRP patients.