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Poster display session

5033 - Evaluation of tumour responses and olaparib efficacy in platinum-sensitive relapsed ovarian cancer (PSROC) patients (pts) with or without measurable disease in the SOLO2 trial (ENGOT Ov-21)

Date

09 Sep 2017

Session

Poster display session

Presenters

Amit Oza

Citation

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

Authors

A.M. Oza1, P. Combe2, J. Ledermann3, S. Marschner4, A. Amit5, T. Huzarski6, N. Lainez Milagro7, A. Savarese8, C. Scott9, M.O. Nicoletto10, P. Harter11, T. Enomoto12, G.S. Sonke13, J. Kim14, I. Vergote15, A. Allen16, E. Pujade-Lauraine17

Author affiliations

  • 1 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 2 Medical Oncology, Hôpital Européen Georges Pompidou, Paris/FR
  • 3 Gynaecological Oncology, UCL Cancer Institute, University College London, WC1E6BT - London/GB
  • 4 Nhmrc Clinical Trials Centre, University of Sydney, Sydney/AU
  • 5 Department Of Obstetrics And Gynecology, Gynecology-oncology Unit, Rambam Health Care Campus, Haifa/IL
  • 6 ,, Pomeranian Medical University, Szczecin/PL
  • 7 Oncología Médica, Complejo Hospitalario de Navarra, Pamplona/ES
  • 8 Mito And Department Of Medical Oncology 1, Regina Elena National Cancer Institute, Rome/IT
  • 9 Department Of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 10 Medical Oncology, Istituto Oncologico Veneto, IRCCS, 35128 - Padova/IT
  • 11 Gynecology And Gynecologic Oncology, Kliniken Essen Mitte, 45136 - Essen/DE
  • 12 Department Of Obstetrics And Gynecology, Niigata University, Niigata/JP
  • 13 Medical Oncology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 14 College Of Medicine, Obstetrics And Gynecology, Seoul National University, Seoul/KR
  • 15 ,, University Hospital Leuven and BGOG, Leuven/BE
  • 16 Oncology Global Medicines Development, AstraZeneca, Gaithersburg/US
  • 17 ,, Université Paris Descartes, AP-HP, , - Paris/FR
More

Resources

Abstract 5033

Background

In SOLO2 (NCT01874353), maintenance therapy with olaparib (Lynparza) significantly prolonged progression-free survival (PFS) vs placebo in pts with PSROC and a BRCA1/2 mutation (BRCAm; hazard ratio 0.30, 95% CI 0.22–0.41; P

Methods

The randomized, double-blind, Phase III SOLO2 study enrolled 295 pts previously treated with ≥2 PBC regimens who were in response after receiving their most recent cycle of PBC. Pts were randomized 2:1 to receive olaparib (300 mg bid; tablet) or placebo. Objective tumour responses were investigator assessed using modified Response Evaluation Criteria in Solid Tumors v1.1.

Results

Table. PFS subgroup analysis for pts with CR or PR at study entry

Olaparib

N=196*

Placebo

N=99

Pts with CR at study entry

n

91

47

Median PFS, months

NR

5.6

HR (95% CI)

0.26 (0.16–0.42)

Pts with PR at study entry

n

105

52

Median PFS, months

13.8

5.5

HR (95% CI)

0.37 (0.25–0.54)

*One patient in the olaparib arm did not receive study treatment. HR, hazard ratio; NR, not reached

At study entry, 73/196 (37%) olaparib pts and 35/99 (35%) placebo pts had measurable disease (evidence of target lesions at baseline); within this group, the adjusted objective response rate (number of pts with CR and PR divided by the number of pts with measurable disease at baseline) was 41.1% with olaparib vs 17.1% with placebo (odds ratio 3.52, 95% CI 1.34–10.59; P=0.0097). The placebo value is higher than expected, possibly due to a carry-over effect from last chemotherapy. In the olaparib arm, 17/113 pts (15.0%) with evidence of disease at baseline achieved CR following maintenance therapy (placebo arm, 5/55 [9.1%]).

Conclusions

Treatment with olaparib not only maintained the response achieved with PBC, but also induced additional antitumour activity in pts with measurable target tumour lesions at baseline. Olaparib monotherapy led to a significant PFS benefit in pts with both CR or PR at study entry, further supporting the role of olaparib as maintenance treatment for pts with PSROC and a BRCAm.

Clinical trial identification

NCT01874353, 1 June 2017

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

J. Ledermann: Honoraria from AstraZeneca and Pfizer, consulting fees from AstraZeneca, Clovis Oncology, Pfizer and Roche. N. Lainez Milagro: Advisory board for AstraZeneca. C. Scott: Received honoraria from Roche, research funding from Roche, Genentech and Clovis Oncology, royalties to the institution from AbbVie, and travel and accommodation expenses from Roche and AstraZeneca. P. Harter: Advisory boards for AstraZeneca, Clovis, Pharmamar, Roche and Tesaro, and lecture fees from AstraZeneca and Roche. T. Enomoto: Lecture fees from Chugai, AstraZeneca, Kaken, Johnson & Johnson, Nihonkayaku and Mochida. G.S. Sonke: Institutional research funding by AstraZeneca, Merck, Novartis and Roche. A. Allen: Employee of AstraZeneca. E. Pujade-Lauraine: E. Pujade-Lauraine has 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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