OvaRex (oregovomab)

In the 97 EOC patients after optimal debulking surgery (residual tumor <1 cm or no gross residual tumor), patients treated with CIT had a dramatical and statistically significant improvement of both progression-free survival (PFS) and overall survival (OS) compared to those treated with chemotherapy alone with a median PFS of 41.8 months versus 12.2 months (hazard ratio &lsqb;HR] 0.46, 95 % confidence interval &lsqb;CI] 0.28-0.7) and OS not yet been reached (NE) versus 42.3 months (HR 0.35, 95 % CI 0.16-0.74), respectively. The current review as Part II will explore the possibility of using CIT as front-line therapy in the management of advanced-stage EOC patients after maximal cytoreductive surgery based on the evidence by many phase 2 studies.

The current standard therapy of epithelial ovarian cancer (EOC) is the combination of surgery (primary cytoreductive surgery or interval cytoreductive surgery) and platinum-based chemotherapy (mainly using paclitaxel and carboplatin either by neoadjuvant chemotherapy and/or by postoperative adjuvant chemotherapy) with/without adding targeted therapy (mainly using anti-angiogenesis agent- bevacizumab)...It is well-known that overexpression of CA125 has been associated with attenuated cellular apoptosis, platinum chemotherapy resistance, tumor proliferation and disease progression, suggesting that anti-CA125 may play a role in the management of patients with EOC. The current review is a Part I which will focus on development of anti-CA125 monoclonal antibody, hoping that alternation of the front-line therapy by chemo-immunotherapy will be beneficial for prolonged survival of patients with EOC.

The primary objective is PFS determined by RECIST 1.1 criteria. Current Trial Status: At the time of abstract submission, 618 patients were enrolled and target enrolment Cohort 1 (378) and Cohort 2 (240) was achieved.

P1b/2, N=54, Recruiting, CanariaBio Inc. | Trial primary completion date: Apr 2023 --> Apr 2024

P2, N=10, Active, not recruiting, CanariaBio Inc. | Trial completion date: May 2024 --> Oct 2024 | Trial primary completion date: Sep 2023 --> Jan 2024

P2, N=10, Active, not recruiting, CanariaBio Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> May 2024 | Trial primary completion date: May 2023 --> Sep 2023

P3, N=615, Active, not recruiting, CanariaBio Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2025

P1b/2, N=54, Recruiting, CanariaBio Inc. | Trial primary completion date: Dec 2021 --> Apr 2023

Patients were assigned to one of the followings: Cohort 1 (prior 1-3 lines of therapy), PLD (40 mg/m2 q4w till PD) + Oregovomab 2 mg (C1,2,3,5,7 for 5 doses) or Cohort 2 (>3 prior lines of therapy), weekly paclitaxel (80 mg/m2 D1,8,15 q4w till PD) + Oregovomab 2 mg (C1,2,3,5,7 for 5 doses). Trial in progress: there are no available results at the time of submission.

Trial in progress: there are no available conclusions at time of submission.

P2, N=10, Recruiting, OncoQuest Pharmaceuticals Inc. | Not yet recruiting --> Recruiting

P2, N=10, Not yet recruiting, OncoQuest Pharmaceuticals Inc.

P1/2, N=31, Recruiting, National Cancer Centre, Singapore | Active, not recruiting --> Recruiting

Since oral treatments as PARP-inhibitors have recently been approved in the OC first-line setting, the possible role of oregovomab needs still to be defined, also considering the intravenous route of administration. The easy to manage toxicity profile makes oregovomab an ideal candidate for association strategies.

P1, N=10, Terminated, OncoQuest Pharmaceuticals Inc. | Trial completion date: Sep 2021 --> Nov 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2021 --> Nov 2020; Sponsor Decision to discontinue long-term follow-up

P1/2, N=13, Terminated, National Cancer Centre, Singapore | N=32 --> 13 | Trial completion date: Dec 2019 --> Apr 2020 | Recruiting --> Terminated; The study had poor efficacy.

P1/2, N=31, Active, not recruiting, National Cancer Centre, Singapore