Table 5 Selected phase II-III clinical trials of virus-based cancer vaccines
Platform | Vaccine | Year, Phase, reference | Target cancer | Route | Results |
|---|---|---|---|---|---|
Sample number | |||||
Viral vector (modified vaccinia Ankara) | TG4010: encoding MUC1 and IL-2 | 2016, phase IIb and III, NCT01383148 [159] | Stage IV NCSLC without activating EGFR mutation and with high expression of MUC1/222 | Subcutaneous | Improved PFS (5.9 vs 5.1Â months) and OS (12.6 vs 10.6Â months) compared to chemotherapy alone |
Viral vector (Vaccinia, fowlpox) | PROSTVAC-VF: encoding PSA and three immune costimulatory molecules | 2010, phase II, NCT00078585 [167] | Minimally symptomatic mCRPC/125 | Subcutaneous | Increased three-year OS rate (30% vs 17%) and extended median survival by 8.5Â months |
2019, phase III, NCT01322490 [168] | Asymptomatic or minimally symptomatic mCRPC/1297 | No improvement compared to placebo | |||
Viral vector (adenovirus) | Nadofaragene firadenovec: IFNA2B | 2021, phase III, NCT02773849 [161] | BCG-unresponsive non-muscle-invasive bladder cancer/151 | Intravesical | 53.4% CR at 3-month; 45.5% of 12Â month-maintained response |
OVs (adenovirus) | H101 | 2004, phase III, not found [174] | Advanced squamous cell carcinomas of the head and neck or esophagus/123 | Intratumoral | Higher ORR (78.8% vs 39.6%) compared to Chemotherapy alone |
OVS (HSV) | Talimogene laherparepvec (T-VEC): encoding GM-CSF | 2019, phase III, NCT00769704 [176] | Unresected stage IIIB to IVM1c melanoma/436 | Intralesional | Higher DRR (19% vs 1.4%) and longer median OS (23.3 vs 18.9Â months) compared to GM-CSF alone |
2023, phase III, NCT02263508 [181] | Unresectable IIIB-IVM1c melanoma/692 | No improvement compared to pembrolizumab | |||
2023, phase II, NCT01740297 [180] | Unresectable stage IIIB‒IV melanoma/198 | Higher ORR (35.7% vs 16.0%) and DRR (33.7% vs 13.0%) | |||
OVs (HSV) | RP-1: encoding GM-CSF and a fusogenic protein | Phase I/II, NCT03767348 | Anti–PD-1–failed advanced melanoma | Intratumoral | Recruiting |