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olvimulogene nanivacirepvec · 2 trials · 15 indications
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
| Arm | Type | Description |
|---|---|---|
| Olvi-Vec + Platinum-doublet & bevacizumab | EXPERIMENTAL | Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0 Platinum-doublet \& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5 |
| Physician's Choice of Chemotherapy & bevacizumab | ACTIVE_COMPARATOR | Physician's Choice of chemotherapy \& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent). |
| Single-arm run-in Olvi-Vec dose escalation Cohorts | EXPERIMENTAL | Cohort 1: Olvi-Vec administered over 3 consecutive days at 0.5,0.5,0.5 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 2: Olvi-Vec administered over 3 consecutive days at 1,1,1 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 3: Olvi-Vec administered over 4 consecutive days at 1,2,3 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. |
| Experimental Arm | EXPERIMENTAL | Olvi-Vec will be administered at the dose and schedule selected from the single-arm run-in Olvi-Vec dose escalation cohorts followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. |
| Active Comparator Arm | ACTIVE_COMPARATOR | Docetaxel starts in Week 0 and continues until disease progression is assessed by the BICR. |
| Active Comparator Arm Cross-over | OTHER | Patients randomized into the Active Comparator can cross-over to receive the same treatment as given in the Experimental Arm following determination of (1) disease progression by BICR after receiving docetaxel treatment and (2) confirming eligibility. |
| Name | Type | Description |
|---|---|---|
| olvimulogene nanivacirepvec | BIOLOGICAL | Olvi-Vec is an engineered oncolytic vaccinia virus |
| Platinum chemotherapy: carboplatin (preferred) or cisplatin | DRUG | Administered according to local practice |
| Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin | DRUG | Administered according to local practice |
| Bevacizumab (or biosimilar) | DRUG | Administered according to local practice |
| Platinum chemotherapy: carboplatin or cisplatin | DRUG | Administered according to local practice. |
| Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC | DRUG | Administered according to local practice. |
| Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab | DRUG | Administered according to local practice. |
| Docetaxel | DRUG | Administered according to local practice. |
Inclusion Criteria: * Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer. * High-grade serous \[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed...
Olvimulogene nanivacirepvec is an investigational oncolytic viral therapy being studied for advanced non-squamous non-small-cell lung cancer and platinum-resistant ovarian cancer. It is also being evaluated in platinum-refractory ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and related ovarian cancer subtypes. The drug is currently in clinical development and is not approved by the FDA.
Olvimulogene nanivacirepvec is a gene therapy modality that uses a modified vaccinia virus to infect and replicate within cancer cells. It is designed to selectively target tumor cells while sparing normal tissue. The therapy is being investigated as a treatment for advanced non-squamous non-small-cell lung cancer and platinum-resistant ovarian cancer.
Olvimulogene nanivacirepvec is being developed by Genelux Corporation, a biopharmaceutical company. Genelux is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with advanced non-squamous non-small-cell lung cancer and platinum-resistant ovarian cancer.
Olvimulogene nanivacirepvec is in Phase 2 clinical development for advanced non-squamous non-small-cell lung cancer. It is also being studied in a Phase 3 trial for platinum-resistant or refractory ovarian cancer. Both trials are currently recruiting patients in the United States. The drug remains investigational and has not received FDA approval.
Olvimulogene nanivacirepvec is being studied in two clinical trials. NCT05281471 is a Phase 3 trial evaluating the drug with platinum-doublet chemotherapy and bevacizumab versus physician's choice chemotherapy in platinum-resistant or refractory ovarian cancer. NCT06463665 is a Phase 2 trial testing the drug with platinum-doublet chemotherapy and an immune checkpoint inhibitor versus docetaxel in non-small-cell lung cancer.
Olvimulogene nanivacirepvec is also known as Olvi-Vec. Clinical trials reference the drug as Olvi-Vec in their titles, including the OnPrime trial for ovarian cancer. Both names refer to the same investigational oncolytic viral therapy being developed by Genelux Corporation.