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Gynaecological cancers

4670 - Efficacy of olaparib maintenance therapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by lines of prior chemotherapy: Phase III SOLO2 trial (ENGOT Ov-21)

Date

09 Sep 2017

Session

Gynaecological cancers

Presenters

Richard Penson

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

R. Penson1, M. Kaminsky-Forrett2, J. Ledermann3, C. Brown4, M. Plante5, J. Korach6, T. Huzarski7, A. Gomez de Liano Lista8, C. Pisano9, M. Friedlander10, N. Colombo11, M. Gropp-Meier12, H. Nakai13, G.S. Sonke14, J. Kim15, I. Vergote16, A. Allen17, E. Pujade-Lauraine18

Author affiliations

  • 1 Medical Gynecologic Oncology, Massachusetts General Hospital, 2114 - Boston/US
  • 2 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 3 Gynaecological Oncology, UCL Cancer Institute, University College London, WC1E6BT - London/GB
  • 4 Nhmrc Clinical Trials Centre, University of Sydney, Sydney/AU
  • 5 Gynecologic Oncology Division, CHU de Québec-Université Laval, Quebec/CA
  • 6 Gynecologic Oncology Department, Chaim Sheba Medical Center, Tel Hashomer/IL
  • 7 ,, Pomeranian Medical University, Szczecin/PL
  • 8 Servicio De Oncología Médica, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 9 Medical Oncology B, Istituto Tumori di Napoli, Naples/IT
  • 10 Medical Oncology, Prince of Wales Hospital, Randwick/AU
  • 11 ,, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 12 Department Of Gynecology And Obstetrics, Oberschwabenklinik Ravensburg, Ravensburg/DE
  • 13 Department Of Obstetrics And Gynecology, Kindai University, Osaka/JP
  • 14 Medical Oncology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 15 College Of Medicine, Obstetrics And Gynecology, Seoul National University, Seoul/KR
  • 16 Gynaecologie-verloskunde, University Hospital Leuven and BGOG, 3000 - Leuven/BE
  • 17 Oncology Global Medicines Development, AstraZeneca, Gaithersburg/US
  • 18 ,, Université Paris Descartes, AP-HP, , - Paris/FR
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Resources

Abstract 4670

Background

In the Phase III SOLO2 trial (NCT01874353), maintenance treatment with the poly(ADP-ribose) polymerase inhibitor olaparib (Lynparza) was shown to significantly improve progression-free survival (PFS) vs placebo in pts with PSROC and a BRCA1/2 mutation (BRCAm; hazard ratio [HR] 0.30, 95% CI 0.22–0.41; P

Methods

SOLO2 enrolled pts who had received ≥2 prior lines of PBC before being in response to their most recent regimen. Pts were randomized 2:1 to receive olaparib tablets (300 mg bid) or placebo. PFS was investigator assessed with modified RECIST v1.1. For the PFS subgroup analyses, subgroups were predefined; HRs were calculated using a Cox proportional hazards model.

Results

Of 295 randomized pts, 195 received olaparib and 99 received placebo. 85 pts in the olaparib arm (43.4%) had received ≥3 prior lines vs 37 pts (37.4%) in the placebo arm.

Table. PFS subgroup analysis by number of prior lines of platinum-based chemotherapy received

Prior lines of platinum-based chemotherapy received

2

3

≥4

Olaparib

Placebo

Olaparib

Placebo

Olaparib

Placebo

n*

110

62

60

20

25

17

PFS events, n (%)

57 (51.8)

44 (71.0)

34 (56.7)

19 (95.0)

16 (64.0)

17 (100)

Median PFS, months

22.1

5.7

16.9

5.1

17.0

5.4

Hazard ratio (95% CI)

0.38 (0.26–0.57)

0.24 (0.13–0.42)

0.26 (0.13–0.51)

*Number of prior lines of platinum-based chemotherapy was unknown for one olaparib-arm patient; Progression or death using modified RECIST version 1.1

Pts who had received 2 prior lines of PBC were more likely to have had a platinum-free interval of >12 months (70.9% vs 48.3% and 40.0% for 3 and ≥4 prior lines, respectively in the olaparib arm; 69.4% vs 60.0% and 23.5% placebo) and a complete response at baseline (50.9% vs 36.7% and 48.0% olaparib; 54.8% vs 35.0% and 35.3% placebo) vs pts who had received ≥3 prior lines.

Conclusions

In SOLO2, olaparib maintenance monotherapy improved PFS in pts with PSROC irrespective of the number of prior lines of PBC received.

Clinical trial identification

NCT01874353, 1 June 2017

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

R. Penson: Honoraria: Amgen, Genentech, AstraZeneca, Endocyte, Eisai, Vascular Biogenics, Baxalta, AbbVie, Clovis, Tesaro; research: Genentech, ImClone, Endocyte, AstraZeneca, Eisai, Amgen, Vascular Biogenics; commercial: Advance Medical. J. Ledermann: Honoraria from AstraZeneca and Pfizer, and consulting fees from AstraZeneca, Clovis Oncology, Pfizer and Roche. M. Friedlander: Research grants and advisory board honoraria from AstraZeneca. N. Colombo: Reports grants and personal fees from AstraZeneca, and personal fees from Roche, Pharmamar, Clovis, Pfizer and Tesaro. M. Gropp-Meier: Honoraria from AstraZeneca. G.S. Sonke: Institutional research funding by AstraZeneca, Merck, Novartis and Roche. A. Allen: Employee of AstraZeneca. E. Pujade-Lauraine: Received advisory board membership and honoraria from AstraZeneca and Pfizer, and advisory board membership, honoraria and speakers\' bureau membership from Roche. All other authors have declared no conflicts of interest.

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