FDA Grants Fast Track Designation to MVR-T3011 in HNSCC


The FDA fast-tracked MVR-T3011, an intratumorally injected oncolytic virus, for treating recurrent or metastatic head and neck squamous cell cancer post-platinum chemotherapy and at least 1 prior anti-PD1/PDL1 therapy.

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  • MVR-T3011 received a fast track designation from the FDA for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC).
  • MVR-T3011 is an oncolytic virus that is currently undergoing evaluation in phase 1 and 2 trials conducted in both the United States and China.
  • An FDA fast track designation aims to aid the development and expedite the review of drugs.

The FDA granted a fast track designation for MVR-T3011, an oncolytic virus product given via intratumoral injection, for the treatment of patients with recurrent or metastatic HNSCC with disease progression following treatment with platinum-based chemotherapy and at least 1 previous line of anti-PD-1/PD-L1 therapy.1

MVR-T3011 is a proprietary 3-in-1 oncolytic virus being developed by ImmVira. The goal of the novel genetic engineered agent is to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. The product works by incorporating the PD-1 antibody and IL-12, which helps to further enhance immune responses in the tumor microenvironment.

Results from phase 1 and 2 trials of the agent which are ongoing in the United States and China support this fast track designation. These studies are focusing on evaluating the efficacy, safety, and durability of response of MVR-T3011 in patients with HNSCC.

This regulatory decision seeks to meet the unmet medical needs associated with HNSCC.

"Attaining fast track designation from the FDA marks a pivotal milestone and underscores MVR-T3011 IT's capacity to address the substantial unmet needs of HNSCC patients," said Grace Guoying Zhou, chairwoman and chief executive officer of ImmVira, in a press release. "We are encouraged by the FDA's decision as it reflects the need for FDA approved and widely available treatments for these patients. This designation will allow us to work closely with the FDA to quickly advance MVR-T3011 IT, to make a meaningful difference for patients who require new treatment options."

3d illustration of throat cancer: © Lars Neumann - stock.adobe.com

3d illustration of throat cancer: © Lars Neumann - stock.adobe.com

Two trials, including an ongoing phase 1/2a study (NCT05602792) being done in China evaluating MVR-T3011 as monotherapy and a phase 1/2a study (NCT04370587) of the agent as a monotherapy or with pembrolizumab (Keytruda) in the United States, had their data shared at the 2023 American Society of Clinical Oncology Annual Meeting.2,3,4 Findings showed that MVR-T3011 demonstrated clinical efficacy when used alone or as a combination therapy.2

The study evaluating MVR-T3011 as a monotherapy study in China included patients with solid tumors who were given the recommended phase 2 dose (RP2D) of the agent. This included 55 patients who were response-evaluable.

As of the data cutoff date of January 18, 2023, the confirmed overall response rate (ORR) was 11% and the disease control rate (DCR) was 49%. A total of 12 patients with HNSCC who progressed after treatment with platinum-based chemotherapy and anti-PD-1/PD-L1 therapy had a confirmed ORR of 25% and DCR of 50%.

Further, 69.2% of patients had increases in tumor-infiltrating CD8-positive cell density in biopsy collected at 8 weeks after the first dose. Specifically, 3 patients with HNSCC who achieved a partial response had an increase in tumor-infiltrating CD8-positive cell density.

For safety, a favorable safety profile was seen along with clinical compliance, and encouraging antitumor activity was observed among patients with HNSCC.

The second study evaluated MVR-T3011 monotherapy or in combination with pembrolizumab. As of January 17, 2023, 29 patients received the combination or MVR-T3011 alone. Preliminary findings showed that among patients with immune-resistant melanoma, the confirmed ORR and DCR was 25.0% and 33.3%, respectively.

Here, the most common treatment-related adverse effect observed among all 90 patients treated with MVR-T3011 was pyrexia. Additionally, there were no dose-limiting toxicities reported, and no additional safety signals observed with the combination therapy.

Trial results showed that MVR-T3011 monotherapy and combination therapy with pembrolizumab were safe and tolerable. MVR-T3011 may modify tumor microenvironment and overcome immune resistance.

The open-label, first-in-human study is enrolling patients with melanoma, sarcoma, squamous cell carcinoma, non-small cell lung cancer (NSCLC), and HNSCC.4 The phase 1 portion of the study is utilizing a 3+3 design to assess escalating doses of MVR-T3011. Total enrollment will be determined based on observed toxicities and/or activity, with approximately 15 to 30 evaluable patients expected to be enrolled.

Part 1 of the phase 2a study will begin once the RP2D is established, and this part will evaluate the safety, tolerability, and preliminary efficacy of MVR-T3011 as a single agent.

Part 2 of the phase 2a portion of the trial plans to assess the safety, tolerability, and preliminary efficacy of MVR-T3011 plus pembrolizumab. This portion plans to include 15 patients with histologically or pathologically confirmed metastatic NSCLC.

Moreover, a rollover arm will be available for those who experience documented progression on MVR-T3011 alone. Here, they will be allowed to receive the agent in combination with pembrolizumab, if deemed eligible.

The study has an estimated completion date of October 31, 2025, and is enrolling patients in Arizona, Massachusetts, Pennsylvania, Texas, Virginia, and Australia.

1. ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment. News release. ImmVira. March 15, 2024. Accessed March 20, 2024. https://tinyurl.com/3fbmx5ma
2. ImmVira presented latest encouraging clinical results of two proprietary products at ASCO 2023. News release. ImmVira. June 6, 2023. Accessed March 20, 2024. https://tinyurl.com/4bd42mvd
3. A study of T3011 administered via intratumoral injection in patients with advanced solid tumors. ClinicalTrials.gov. Updated November 2, 2022. Accessed March 20, 2024.https://clinicaltrials.gov/study/NCT05602792
4. A clinical study of intratumoral MVR-T3011 (T3011) given as a single agent and in combination with intravenous pembrolizumab in participants with advanced or metastatic solid tumors. ClinicalTrials.gov. Updated August 29, 2023. Accessed March 20. 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04370587
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