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Gynaecological cancers

2965 - Vanucizumab (VAN) in combination with atezolizumab (ATEZO) for platinum-resistant recurrent ovarian cancer (PROC): Results from a single arm extension phase of the phase I study BP28179

Date

09 Sep 2017

Session

Gynaecological cancers

Presenters

Ana Oaknin

Citation

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

Authors

A. Oaknin1, I. Vergote2, I. Ray-Coquard3, A. Leary4, V. Rodriguez Freixinos1, N. Concin2, P. Toussaint3, C. Massard4, L. Fariñas-Madrid1, E. Van Nieuwenhuysen2, A. Lahr5, I. Franjkovic5, S. Rossomanno6, P. Gerber6, T. Nayak7, F. Heil8, C. Boetsch7, A. Sahbi9, K. Longauer7, O. Krieter5

Author affiliations

  • 1 Medical Oncology Department, Vall d'Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 2 Department Of Obstetrics And Gynaecology And Gynaecologic Oncology, University Hospital, Leuven/NL
  • 3 Oncologie Médicale, Université Claude Bernard Lyon I, Lyon/FR
  • 4 Gynecology Unit, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 5 Pharma Research And Early Development, Roche Innovation Center Munich, 82337 - Penzberg/DE
  • 6 Pharma Research And Early Development, Roche Innovation Center Basel, 4070 - Basel/CH
  • 7 Pharma Research And Early Development, Roche Innovation Center Basel, Basel/CH
  • 8 Pharma Research And Early Development, Roche Innovation Center Munich, 82377 - Penzberg/DE
  • 9 Pharma Research And Early Development, Roche Innovation Center Welwyn, Welwyn/GB
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Resources

Abstract 2965

Background

VAN is a bi-specific human IgG1 antibody, simultaneously blocking two key angiogenic factors, Ang-2 and VEGF-A. VAN as a single agent showed an objective response rate (ORR) of 29% in bevacizumab- naïve PROC. The anti-PD-L1 agent, ATEZO demonstrated a 22% ORR in advanced OC. Preclinical data suggested additive antitumor activity of VAN when combined with anti−PD-L1. Hence, treatment with VAN plus ATEZO has the potential to reverse pro-angiogenic and immune-suppressive signals, thereby resulting in improved clinical benefit.

Methods

Eligible patients (pts) had PROC measurable by RECIST 1.1. Pts with history of bowel obstruction, > 2 prior lines of systemic chemotherapy, or previous treatments with VEGF-A inhibitors or agents targeting Ang/Tie2 receptor axis were ineligible. Pts received VAN 2000 mg and ATEZO 840 mg, each IV Q2W, until disease progression or unacceptable toxicity. Primary efficacy endpoint was ORR as per RECIST 1.1, with tumor assessments every 8 weeks.

Results

17 pts with median age of 63 years (range 45-74) were treated. Serous histology was present in all pts, except one clear cell subtype. 4 pts (24%) achieved confirmed PR, 8 pts (47%) experienced SD and 4 (24%) had PD, while one patient was not evaluable. The achieved RECIST ORR of 24% remained unchanged when evaluated as per immune-related response criteria. 9/17 pts were evaluable for CA-125 per GCIG criteria; three and two achieved a response with and without normalization respectively. The current estimate of PFS rate @ 6 months is 65% (median follow-up: 162 days). The most common adverse events (AE) of any grade (G) were decreased appetite, diarrhea (41% each), asthenia and constipation (35% each). AEs ≥ G3 included abdominal pain, LFT increase, asthenia, dyspnea, health deterioration, hypertension, GI obstruction, GI perforation (GIP), subileus, lymphedema, pleuritis and tonsillitis (6% each). One AE of GIP and asthenia each were fatal.

Conclusions

Our data suggest that VAN plus ATEZO does not improve upon monotherapy with VAN or ATEZO in PROC. The safety profile of this combination is consistent with reports for the single agents in this setting.

Clinical trial identification

NCT01688206

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd

Funding

Roche

Disclosure

A. Oaknin: Advisory Board and/or Board of Directors for Roche, AstraZeneca, Clavis, PharmaMar. I. Vergote: Research (via KULeuven) for Amgen, Exelixis, Lilly, Morphotek, Pronota, Roche; Advisory Boards and/or Board of Directors for Roche, Genentech and multiple other pharmaceutical companies exceeding the character limit and thus not listed here. I. Ray-Coquard: Advisory Board for Roche. A. Leary: Advisory board and/or board of directors for AstraZeneca, Clovis, GamaMabs; Research funding: GamaMabs, Merus. A. Lahr, I. Franjkovic, S. Rossomanno, A. Sahbi, K. Longauer: Employment Roche. P. Gerber, F. Heil, C. Boetsch, O. Krieter: Stock options and employment Roche. T. Nayak: Stock options. All other authors have declared no conflicts of interest.

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