Oncolytics Biotech Inc Announces Phase II Trial with REOLYSIN for Ovarian Cancer

Strategic Insights -

The Gynaecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. The study, GOG186H, has been approved and will be sponsored by the Cancer Therapy Evaluation Programme, Division of Cancer Treatment and Diagnosis, US National Cancer Institute (NCI). The study aims to estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel with REOLYSIN to weekly paclitaxel alone and to determine the frequency and severity of adverse events associated with treatment.

Key Takeaways:

  • The GOG186H study will be a randomized Phase II trial with up to 150 patients enrolled, aiming to estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel with REOLYSIN to weekly paclitaxel alone.
  • The primary objectives of the trial are to estimate the progression-free survival hazard ratio and to determine the frequency and severity of adverse events associated with treatment.
  • The study will also estimate the progression-free survival and overall survival of patients treated with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN.
  • The trial will assess progression-free survival and overall survival in patients with measurable disease (RECIST 1.1 criteria) and patients with detectable (nonmeasurable) disease.
  • The study chair will be Dr. David E Cohn of The Ohio State University Comprehensive Cancer Center - Arthur G James Cancer Hospital and Richard J Solove Research Institute.
  • Oncolytics will provide clinical supplies of REOLYSIN for the study, which is sponsored by the NCI with its Clinical Trials Agreement.

Statistics:

  • The study will aim to enroll up to 150 patients.
  • Patients will receive standard doses of paclitaxel on days one, eight, and 15 every 28 days.
  • Patients in the second arm will also receive intravenous REOLYSIN on days one through five of each 28-day cycle at a dose of 3x1010 TCID50.
  • The study is expected to have a duration of unknown length, as the enrolled time period is not specified in the press release.

Sources:

  • Oncolytics Biotech Inc
  • The Gynaecologic Oncology Group (GOG)
  • Cancer Therapy Evaluation Programme, Division of Cancer Treatment and Diagnosis, US National Cancer Institute (NCI)
  • The Ohio State University Comprehensive Cancer Center - Arthur G James Cancer Hospital and Richard J Solove Research Institute
  • REOLYSIN (R)