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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 oncology therapy being studied for platinum-resistant ovarian cancer and advanced non-squamous non-small-cell lung cancer. It is being evaluated in clinical trials for these indications, including platinum-resistant or refractory ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and advanced or metastatic non-small-cell lung cancer.
Olvimulogene nanivacirepvec is a gene therapy modality, classified under the -vec/-gene target class. It is designed to deliver genetic material for therapeutic effect in oncology. The specific molecular target is not disclosed in the available information.
Olvimulogene nanivacirepvec is being developed by Genelux Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol GNLX. The company is conducting clinical trials to evaluate the drug's efficacy and safety in ovarian cancer and non-small-cell lung cancer.
Olvimulogene nanivacirepvec is in Phase 2 clinical development. It is currently being studied in a Phase 2 trial for advanced non-squamous non-small-cell lung cancer, and it is also being evaluated in a Phase 3 trial for platinum-resistant ovarian cancer. The drug is investigational and not yet approved.
Olvimulogene nanivacirepvec is being studied in two clinical trials. NCT05281471 is a Phase 3 trial in platinum-resistant or refractory ovarian cancer, comparing olvi-vec plus platinum-doublet and bevacizumab to physician's choice of chemotherapy and bevacizumab. NCT06463665 is a Phase 2 trial in advanced non-squamous non-small-cell lung cancer, comparing olvimulogene nanivacirepvec plus platinum-doublet and immune checkpoint inhibitor to docetaxel.
Yes, Olvimulogene nanivacirepvec is also known as Olvi-Vec. The clinical trial NCT05281471 refers to the drug as Olvi-Vec in its title, while NCT06463665 uses the full name Olvimulogene Nanivacirepvec. Both names refer to the same investigational therapy being developed by Genelux Corporation.