Source: FDA, National Drug Code (US) Revision Year: 2026
TUDRIQEV is an oncolytic viral therapy which preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R– expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote an anti-tumor immune response.
No studies have been performed to evaluate the pharmacodynamics of TUDRIQEV.
In the IGNYTE Study, TUDRIQEV biodistribution and viral shedding were assessed using a quantitative polymerase chain reaction (qPCR) assay. Blood, urine, and swab samples were collected from injection site(s), injection-site(s) dressings, and oral mucosa of 278 patients receiving TUDRIQEV. Samples were collected before dosing, during treatment, at 30 and 60 days following the last TUDRIQEV injection, and up to 100 days after the last dose of study treatment (either TUDRIQEV or nivolumab). Patients were asked to report any appearance of herpetic-like lesions in caregivers or close contacts. As the presence of DNA does not equate to live/infectious TUDRIQEV, DNA-positive swab samples were further assessed in a validated 50% tissue culture infectious dose (TCID50) assay, which detects live TUDRIQEV.
TUDRIQEV DNA was detected in blood samples from 53 out of 274 (19%) patients within 6 hours of injection with decreasing levels thereafter. TUDRIQEV DNA was detected in 3 out of 1976 (0.2%) urine samples. TUDRIQEV is cleared from both blood and urine after 30 days, with all samples from follow-up visits testing negative for TUDRIQEV DNA. No sample had detectable TUDRIQEV DNA 30-days after the end of treatment in blood, urine, swab samples collected from injection site(s), injection-site(s) dressing, or oral mucosa. TUDRIQEV DNA was detected on the surface of injected lesions in 112 of 266 (42%) patients, and 358 of 1947 (18%) tested samples. Consistent with the kinetics of TUDRIQEV replication in tumors, TUDRIQEV DNA was present at the injection site up to 15 days post injection in approximately 20% of patients. The incidence of detection of TUDRIQEV DNA in the exterior of injection site dressings was lower than at the injection site with samples from 43 of 207 (21%) patients' exterior of injection-site dressing samples testing positive for TUDRIQEV DNA. Positive samples were further assessed for live TUDRIQEV. Out of 314 samples, 4 tested positive by TCID50. The reported incidence of TUDRIQEV transmission to close contacts was 0%.
No differences in the incidence of detectable TUDRIQEV DNA were observed between patients who were HSV-1 seronegative or seropositive at baseline.
No studies have been conducted with TUDRIQEV to assess its mutagenic or carcinogenic potential or effects on male fertility [see Use in Specific Populations (8.1)].
The efficacy of TUDRIQEV in combination with nivolumab was evaluated in an open-label, multiregional, single-arm study (IGNYTE; NCT03767348). The study enrolled adult patients with stage IIIB, IIIC, or IV unresectable advanced melanoma who had previously been treated with at least eight consecutive weeks of immediate prior anti-PD-1-based therapy and experienced disease progression while being on the anti-PD-1-based therapy and subsequently confirmed by imaging, biopsy or clinical observation.
The study excluded patients who had received prior oncolytic virus therapy, uncontrolled or untreated central nervous system (CNS) metastasis, an active or history of hepatitis B, hepatitis C, HIV infection, prior severe complications from HSV-1 infection, and patients requiring chronic systemic corticosteroids.
Patients received TUDRIQEV by intratumor injection every 2 weeks for 8 consecutive injections, starting at a concentration of 106 PFU/mL at week 1 followed by TUDRIQEV at a concentration of 107 PFU/mL for the remaining doses. Starting with the second dose of TUDRIQEV, nivolumab was administered at a dose of 240 mg by intravenous infusion every 2 weeks for 16 weeks followed by nivolumab single agent at a dose of 480 mg by intravenous infusion every 4 weeks for up to a total of 24 months.
At investigator discretion, patients could receive up to 16 additional doses of TUDRIQEV at a concentration of 107 PFU/mL every 2 weeks either in combination with nivolumab or as monotherapy if nivolumab was previously stopped due to toxicity related to nivolumab.
Among the 140 patients, 91 patients with at least one noninjected lesion were included in the efficacy population (Table 3). Of those 91, the population characteristics were as follows: median age was 62 years (range: 23 to 91), 68% were male, 68% were White, 30% were of "unknown" race; Eastern Cooperative Oncology Group (ECOG) performance status was 0 (68%), 1 (32%); 80% had Stage IV disease. Of these 91 patients, 45%, 24%, and 7% of patients had lung, liver, and brain lesions, respectively. All patients received at least one prior anti-PD-1 based therapy. Prior anti-PD-1 therapy was given in the adjuvant treatment setting for 13% of patients. Tumor PD-L1 expression was negative (<1%) in 54% of patients.
The primary efficacy outcome was objective response rate (ORR) and the secondary outcome measure was duration of response (DOR). Tumor responses were assessed using radiographic imaging and/or caliper measurements with photography every 8 weeks.
The main efficacy results are summarized in Table 3.
Table 3. Efficacy Results for the IGNYTE Study:
| Endpoints | N=91 |
| Objective Response Rate | |
| ORR % (95% CI) | 24.2 (15.8, 34.3) |
| Duration of response (DoR) | |
| Median DoR in months (95% CI)* | 14.1 (10.7, NR) |
| DoR range, months | 3.9 to 34.6+ |
| % Patients with DoR ≥6 months* | 86.1 |
| % Patients with DoR ≥12 months* | 54.6 |
NR, not reached.
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