OnPrime Study of Olvi-Vec, Platinum-Doublet, and Bevacizumab Initiates in Ovarian Cancer

The phase 3 OnPrime trial (NCT0528147, GOG-3076) evaluating the efficacy and safety of Olvi-Vec (olvimulogene nanivacirepvec), platinum-doublet chemotherapy, and bevacizumab (Avastin) compared with platinum-doublet chemotherapy plus bevacizumab has begun examining patients with platinum-resistant/refractory ovarian cancer, according to Genelux Corporation.¹

Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus which works to increase its safety, tumor selectivity and therapeutic potential to result in immunogenic cell death. The agent triggers immune activation and memory for long-term immunotherapy to fight against cancer.

In preclinical studies, Olvi-Vec has been administered to more than 150 patients and was generally well tolerated and has demonstrated evidence of clinical benefit.

“Initiating the OnPrime trial represents a major milestone for Genelux,” said Thomas D. Zindrick, president and chief executive officer of Genelux, in the press release. “Based on the positive results of our VIRO-15 phase 2 trial, we believe that Olvi-Vec-primed immunochemotherapy has the potential to address the high unmet need of patients living with platinum-resistant/refractory ovarian cancer. Our goal in phase 3 is to replicate these positive results and transform the treatment paradigm for this particularly difficult-to-treat cancer. We look forward to progressing our study and sharing updates on the Olvi-Vec clinical development program.”

The multicenter, randomized, open-label, phase 3 OnPrime trial will be conducted at approximately 30 sites across the country and has a planned enrollment of 186 women with platinum-resistant/refractory ovarian cancer.²

Patients will be randomized in a 2:1 ratio to either the experimental arm of Olvi-Vec, platinum-doublet chemotherapy, and bevacizumab or the active comparator arm of platinum-doublet plus bevacizumab.

Enrollment in the trial is open to patients aged 18 years and older with histologically confirmed non-resectable ovarian, fallopian tube or primary peritoneal cancer. Patients must have high-grade serous endometrioid, or clear-cell ovarian cancer, an performance status ECOG of 0 or 1, and a life expectancy of 6 months or greater.

Further requirements include a minimum of 3 prior lines of systemic therapy with no maximal limit, prior bevacizumab or biosimilar treatment, to have at least 1 measurable target lesion per RECIST 1.1, adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count, have disease progression after last prior line of therapy, and have no contraindication to receive carboplatin, cisplatin or bevacizumab.

The primary end point of the trial is progression-free survival (PFS) in the intention-to-treat (ITT) population. Secondary end points of incidence of treatment-emergent adverse events in the ITT population, to determine the safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab, duration of response, PFS in the modified ITT population and ITT population, overall response rate, and overall survival.

Preclinical studies have evaluated Olvi-Vec as a monotherapy and in combination with other therapies, in approximately 150 patients with a variety of cancer types.

The VIRO-15 phase 2 (NCT02759588) trial enrolled 27 patients with platinum-resistant/refractory ovarian cancer who received a median of 4 prior lines and whose disease progressed after the last prior line. In the trial, Olvi-Vec met the pre-established efficacy and safety end points with a median PFS of 11.0 months (95% CI, 6.7-13.0), ORR of 54%, and ORR by GCIG CA-125 of 85%.

Regarding safety, the most frequent grade 3 treatment-related adverse event was abdominal pain (7.4%), and there were no observed treatment-related discontinuations or patient deaths.

Now, the phase 3 OnPrime trial is actively recruiting patients in Orlando, Florida with an estimated study completion date of October 2026.

References:

Genelux Corporation Initiates a Pivotal Phase 3 Trial, Evaluating Olvi-Vec for the treatment of Platinum-Resistant/Refractory Ovarian Cancer. News release. Genelux Corporation. September 21, 2022. Accessed September 26, 2022. https://finance.yahoo.com/news/genelux-corporation-initiates-pivotal-phase-120600334.html?guccounter=1

Efficacy & safety of Olvi-Vec and platinum-doublet + bevacizumab compared to platinum-doublet + bevacizumab in platinum-resistant/refractory ovarian cancer (OnPrime, GOG-3076). ClinicalTrials.gov. Updated September 6, 2022. Accessed September 26, 2022.https://clinicaltrials.gov/ct2/show/NCT05281471