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Also known as Olvi-Vec, GL-ONC, GLV-1h68
Olvimulogene nanivacirepvec · 4 trials · 18 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.
Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0
Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer.
To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
| 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. |
| Experimental | EXPERIMENTAL | Olvi-Vec will be administered for 3 days in C1, then starting from C2, platinum (platinum (cisplatin or carboplatin)) and episode are administrated each 21 days till patients could not tolerate. |
| Phase 1b - Cohort 1 | EXPERIMENTAL | Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu. |
| Phase 1b - Cohort 2 | EXPERIMENTAL | Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu. |
| Phase 1b - Cohort 3 | EXPERIMENTAL | Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu. |
| Phase 2 | EXPERIMENTAL | Participants treated in the Phase 2 portion received 2 IP infusions of Olvi-Vec at 3 x 10e9 pfu followed by platinum-doublet chemotherapy with or without bevacizumab. |
| 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. |
| Olvi-Vec | DRUG | Olvi-Vec will be administered to patient for 3 days during C1 |
| platinum (cisplatin or carboplatin) | DRUG | After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Platinum （Carboplatin or Cisplatin）will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred. |
| Etoposide | DRUG | After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Etoposide will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred. |
| Platinum-doublet with or without bevacizumab | DRUG | Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab. |
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 gene therapy being studied in oncology for advanced non-squamous non-small-cell lung cancer, ovarian cancer including platinum-resistant ovarian cancer, and extensive stage small-cell lung cancer. It is being developed by Genelux Corporation under the ticker GNLX and is currently in Phase 2 development.
Olvi-Vec is the alternative name for olvimulogene nanivacirepvec, an investigational gene therapy developed by Genelux Corporation (GNLX). It is being studied in oncology across advanced non-squamous non-small-cell lung cancer, ovarian cancer including platinum-resistant ovarian cancer, and extensive stage small-cell lung cancer. Olvi-Vec and olvimulogene nanivacirepvec refer to the same drug asset.
Olvimulogene nanivacirepvec is being developed by Genelux Corporation, which trades under the ticker GNLX. The company is advancing the gene therapy across oncology indications including advanced non-squamous non-small-cell lung cancer, ovarian cancer, platinum-resistant ovarian cancer, and extensive stage small-cell lung cancer.
Olvimulogene nanivacirepvec is in Phase 2 development. It is an investigational gene therapy and has not been approved. Clinical work spans Phase 1, Phase 2, and Phase 3 studies, with the Phase 3 trial evaluating the drug in platinum-resistant and platinum-refractory ovarian cancer.
Olvimulogene nanivacirepvec is being studied in several trials. NCT06463665 is a recruiting Phase 2 study in advanced non-squamous non-small-cell lung cancer. NCT05281471 is a recruiting Phase 3 trial in platinum-resistant and platinum-refractory ovarian cancer. NCT07136285 is a recruiting Phase 1 study in extensive stage small-cell lung cancer, and NCT02759588 was a completed Phase 1 ovarian cancer trial.
Yes, Olvi-Vec is another name for olvimulogene nanivacirepvec. Both names refer to the same investigational gene therapy from Genelux Corporation (GNLX), which is being studied in oncology for advanced non-squamous non-small-cell lung cancer, ovarian cancer including platinum-resistant ovarian cancer, and extensive stage small-cell lung cancer.