Genelux Corporation Announces Publication of Positive Topline Data from Phase 2 VIRO-15 Trial Evaluating Olvimulogene Nanivacirepvec (Olvi-Vec) in Platinum-Resistant or Refractory Ovarian Cancer in the Journal of the American Medical Association (JAMA) Oncology
- Phase 2 Trial of Olvi-Vec-primed immunochemotherapy in heavily pre-treated patients
- Met primary endpoint of objective response rate with deep and durable responses
- Generated promising progression-free survival
- Demonstrated clinical reversal of platinum resistance and refractoriness
- Phase 3 OnPrime/GOG-3076 randomized active-controlled registrational trial in collaboration with
GOG Foundation/Partners is currently enrolling
- The Article was featured on JAMA Oncology’s podcast with lead investigator,
Robert W. Holloway, MD
“We are incredibly pleased to have the Phase 2 trial data featured as an Original Investigation in such a prominent peer-reviewed journal. The results published in JAMA Oncology add to the body of evidence supporting the clinically-meaningful efficacy and safety of Olvi-Vec," said
Patients with PRROC have limited therapeutic options, representing a considerable unmet medical need. In this Phase 2 clinical trial of 27 patients [platinum-resistant (n=14) or platinum-refractory (n=13)] and median 4 prior lines of therapy, Olvi-Vec followed by platinum-based chemotherapy ± bevacizumab as immunochemotherapy demonstrated objective response rate (ORR) of 54% and a median progression-free survival (PFS) of 11.0 months with a manageable safety profile.
- All patients completed both Olvi-Vec infusions and chemotherapy. Median follow-up duration was 47.0 months (95% CI, 35.9 months to NA, upper limit not reached).
- ORR by RECIST1.1 was 54% (95% CI, 33%-74%), with Duration of Response of 7.6 months (95% CI, 3.7-9.6 months). Disease Control Rate was 88% (21/24). Overall, 19 of 22 evaluable patients (86%) showed tumor shrinkage. ORR by tumor biomarker CA-125 was 85% (95% CI, 65%-96%), and 25 of 26 evaluable patients (96%) exhibited decreased CA-125 levels.
- Median PFS by RECIST1.1 was 11.0 months (95% CI, 6.7-13.0 months), and 6-month PFS rate was 77% in all patients. Median PFS was 10.0 months (95% CI, 6.4-NA months) in the platinum-resistant group and 11.4 months (95% CI, 4.3-13.2 months) in the platinum-refractory group.
- Median overall survival (OS) was 15.7 months (95% CI, 12.3-23.8 months) in all patients, with median OS of 18.5 months (95% CI, 11.3-23.8 months) in platinum-resistant group and 14.7 months (95% CI, 10.8-33.6 months) in platinum-refractory group.
- Most frequent treatment-related adverse events (TRAEs) (any grade, grade 3) were pyrexia (63.0%, 3.7%) and abdominal pain (51.9%, 7.4%). There were no grade 4 treatment-related adverse events and no treatment-related discontinuations or deaths.
About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Vaccinia virus is a non-human pathogen utilized as a vaccine to eradicate smallpox. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit.
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Olvi-Vec being a life-changing therapy for patients with PRROC. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’ filings with the
Investor and Media Contacts
Source: Genelux Corporation