ImmVira Clinical Snapshot: Intratumoral Injected OV (MVR-T3011 IT) Monotherapy Achieved Median PFS of 12.9 Months on Treatment of Melanoma
Source: CISION Prn News Wire, February 2023
SHENZHEN, China, Feb. 8, 2023 /PRNewswire/ — ImmVira’s first intratumoral injected OV product MVR-T3011 IT has shown positive efficacy in the course of clinical studies in the U.S. and China as of January 2023, with which the monotherapy treatment significantly prolonged PFS to a median of 12.9 months among melanoma patients who had failed previous immune-oncology treatment. Currently, late-stage melanoma faces poor prognosis. Clinical studies have found that median PFS of only 1.7 months for stage IV patients, second-line mono immunotherapy achieved median PFS of 2.8 and 3.6 months, combination therapy of PD-1 Ab and VEGF inhibitor achieved median PFS of 4.2 months.
This Phase II clinical study commenced in mid-2021 in the U.S. and China. 19 patients with advanced melanoma who had failed prior PD-1 or PD-1/CTLA-4 combination treatment received MVR-T3011 IT monotherapy, and nearly 90% of subjects had distant metastasis and over 50% of subjects had baseline target lesion diameters that added up to more than five centimeters. After receiving local monotherapy of MVR-T3011 IT, the confirmed ORR and DCR (including low dosage cohorts in dose-escalation stage) was 21.1% (4/19) and 47.4% (9/19), respectively. Median PFS was 12.9 months, and 12-month PFS rate was 51.5%. Median PFS significantly increased, also showing MVR-T3011 IT’s potential in reversing resistance of immune checkpoint inhibitors.
In the clinical studies KEYNOTE-151 and POLARIS-01, the ORR of PD-1 Ab (pembrolizumab/ toripalimab) in Chinese subjects with advanced melanoma treated with second-line monotherapy was 17.6% and 17.3%, respectively, with the median PFS of 2.8 months and 3.6 months, respectively. In LEAP-004, a Phase II study of second-line subjects with recurrent or metastatic melanoma who had failed prior PD-1 or PD-1/CTLA-4 treatment, the combination of VEGF inhibitor (lemvastinib) and PD-1 Ab (pembrolizumab) had an ORR of 21% and a median PFS of 4.2 months. Compare with the clinical studies in patients at a similar stage, the efficacy of MVT-T3011 IT monotherapy topical administration demonstrated encouraging results.