Phase 2 trial of oncolytic immunotherapy launches in BCG-unresponsive NMIBC

The first patient has been dosed in a phase 2 trial (NCT06971614) investigating MVR-T3011, an oncolytic immunotherapy for patients with BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC), ImmVira announced in a news release.¹

According to the company, MVR-T3011 is “a novel oncolytic immunotherapy combining a proprietary replication competent oncolytic virus backbone with payload expression of PD-1 Ab and IL-12.”

Vignesh T. Packiam, MD

"MVR-T3011 represents a novel drug design and has the potential to address an unmet need in NMIBC,” said Vignesh T. Packiam, MD, principal investigator and the director of clinical and translational research in urologic oncology at Rutgers Cancer Center in New Jersey, in the news release.¹ “Integration of PD-1 Ab and IL-12 genes into the genome of this novel oncolytic immunotherapy can augment immune responses in the tumor microenvironment and prolong the early-phase antitumor efficacy.”

In total, the single-arm, open-label trial plans to enroll 70 patients through 15 to 20 clinical trial sites across the US and China.² Patients are eligible for enrollment if they have adequate laboratory test values, and ECOG Performance Status of 0 to 2, and an expected survival of at least 24 weeks.²

In the study, MVR-T3011 will first be dosed at a level of 2×10⁹ PFU. If there are no safety concerns following the dose-limiting toxicity assessment, the investigators will then assess outcomes at the 1×10¹⁰ PFU dose level.

Treatment will include both an induction and a maintenance period. In the induction period, patients will receive MVR-T3011 once a week for 6 weeks, followed by 6 weeks of observation and an efficacy assessment at 3 months. In the maintenance period, patients will receive MVR-T3011 every 3 weeks until approximately 24 months or until they meet the criteria for treatment discontinuation.

The objectives of the trial are to further confirm the recommended phase 2 dose and to assess the efficacy of MVR-T3011. The primary end points for the trial are complete response rate in patients with carcinoma in situ (CIS), recurrence-free survival in patients with high-grade Ta/T1 without CIS, and the incidence of dose-limiting toxicities across 2 dose levels. Secondary end points include longer-term (18 to 24 months) efficacy assessments and safety.

Primary completion of the trial is expected for December 2028.

Grace Guoying Zhou, PhD

"The initiation of this multi-country phase 2 study marks a major milestone for ImmVira," said Grace Guoying Zhou, PhD, co-founder, CEO, and chairwoman of ImmVira, in the news release.¹ "We are delighted with the notable progress and results achieved in the phase I clinical trial of MVR-T3011 for the treatment of NMIBC and are extremely excited about working with key thought leaders in the U.S. and China to further explore the potential of this drug in NMIBC patients."

Data on MVR-T3011

Data from a phase 1 study of MVR-T3011 were shared at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain.³

At a data cutoff of June 2024, 14 patients were evaluable for efficacy. Among those, the 3-month complete response (CR) rate across all dose levels was 71.4% (10 of 14). At the 2×10⁹ PFU dose level, the CR rate was 87.5% (7 of 8). There were no dose-limiting toxicities reported, and a maximum tolerated dose had not been reached.

Updated findings with a data cutoff of September 2024 were also shared by ImmVira, which included data from 20 patients in the study.⁴ At the dose level of 2×10⁹ PFU, the 3-month CR rate was consistent at 81.8% (9 of 11).

Based on these results, the authors concluded, “Intravesical T3011 demonstrates promising anti-tumor efficacy and an excellent safety profile in patients with high-risk BCG-failure NMIBC.”

REFERENCES

1. ImmVira announces first patient dosed in a multi-regional phase II clinical trial evaluating MVR-T3011 oncolytic immunotherapy in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC). News release. ImmVira. Published online and accessed June 10, 2025. https://www.prnewswire.com/news-releases/immvira-announces-first-patient-dosed-in-a-multi-regional-phase-ii-clinical-trial-evaluating-mvr-t3011-oncolytic-immunotherapy-in-patients-with-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer-nmibc-302477586.html

2. A study of T3011 in patients with BCG-unresponsive high risk NMIBC. ClinicalTrials.gov. Last updated May 14, 2025. Accessed June 10, 2025. https://clinicaltrials.gov/study/NCT06971614

3. Ye D, Wu J, Zhou G, et al. Preliminary results from a phase I study of T3011, an oncolytic HSV expressing IL-12 and anti-PD-1 antibody, for BCG-failure non-muscle-invasive bladder cancer (NMIBC). Annals of Oncol. 2024;35 (suppl 2, S1156). https://www.annalsofoncology.org/article/S0923-7534(24)03603-2/fulltext

4. ESMO 2024 - ImmVira unveils clinical results of intravesical MVR-T3011 for high-risk BCG-failure NMIBC patients. News release. ImmVira. September 15, 2024. Accessed June 10, 2025. https://www.immviragroup.com/news/561.html