On February 5, 2024, the U.S. Food and Drug Administration (FDA) approved a Fast Track designation for the UV1 cancer vaccine in combination with ipilimumab and nivolumab for patients with inoperable mesothelioma, an aggressive cancer caused by asbestos exposure.

The Fast Track designation allows the FDA to accelerate the review of the vaccine developed by biotechnology company Ultimovacs ASA, possibly allowing UV-1 to reach patients sooner.

This designation streamlines the drug review process with:

  • The ability to submit data and related materials in segments as they are completed
  • More frequent meetings and communications with the FDA to resolve questions
  • Prioritized review by the FDA

“We are pleased that the FDA has granted Fast Track designation for UV1. [It has] demonstrated a positive safety profile and encouraging signs of improvement in overall survival in combination with the checkpoint inhibitors ipilimumab and nivolumab in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need.”

- Carlos de Sousa, CEO of Ultimovacs

The news follows positive results from a clinical trial that combined the UV1 vaccine with the immunotherapy medications Opdivo® and Yervoy®. The trio of drugs successfully improved overall survival compared to those who only received immunotherapy.

Learn more about the UV1 vaccine and its success in the mesothelioma clinical trial below.

Understanding the Therapeutic UV1 Vaccine

The immunotherapy drug combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was approved by the FDA as a first-line (standard) treatment for pleural mesothelioma after studies showed it improved survival. However, this combination alone doesn’t work for all patients, leading researchers to explore a new approach.

One of the challenges in treating mesothelioma has been identifying specific targets for treatment. Ultimovacs designed its UV1 vaccine to target the enzyme telomerase, which is a known biomarker, or sign, of cancer.

In fact, telomerase is present in 85-90% of cancers regardless of how far tumors have spread, meaning that UV1 may work as a universal vaccine for various types and stages of cancers.

Similarly to other types of immunotherapy treatment, mesothelioma vaccines aim to help the body’s immune system fight off cancer cells. While no mesothelioma vaccines have been approved by the FDA yet, this Fast Track designation for UV1 could soon lead to it becoming the first approved cancer vaccine for mesothelioma.

A mesothelioma specialist can help you access the latest treatments being tested in clinical trials. Use our Free Doctor Match to get connected with a specialist now.

About the NIPU Phase II Clinical Trial

The FDA cited the positive results of UV1’s phase II clinical trial sponsored by Oslo University as the reason why it approved the request for Fast Track designation. The trial compared UV1 in combination with immunotherapy as a second-line treatment for pleural mesothelioma.

Did You Know?

Second-line treatments are used when a patient’s cancer does not respond well to other standard therapies.

Known as NIPU (nivolumab and Ipilimumab plus/minus UV1 vaccination), the clinical trial involves 118 pleural mesothelioma patients whose cancer had already spread after they received chemotherapy as a first-line treatment.

From there, the patients were split into 2 groups, with:

  • All patients getting Opdivo (nivolumab) every 2 weeks and Yervoy (ipilimumab) every 6 weeks until the cancer spread, the side effects became too much, or 2 years passed
  • An experimental group receiving an additional 8 injections of the UV1 cancer vaccine within the first 3 months of care

By splitting the groups this way, researchers were able to test the influence of immunotherapy on their own and then with the UV1 vaccine for mesothelioma.

Results of the NIPU Phase II Clinical Trial

The results of the phase II NIPU clinical trial were revealed at the European Society for Medical Oncology Congress in October 2023.

When used as an add-on to treatment with nivolumab and ipilimumab, the UV1 cancer vaccine resulted in:
  • 27% improved survival and a life expectancy of 15.4 months — 4 months longer than immunotherapy alone
  • 31% of patients in the UV1 group achieved partial or complete remission, as opposed to the 16% in the group that didn’t receive the vaccine
  • No additional side effects or toxicities from the combination of drugs

These results are great news for patients who are not eligible for surgery and who may not have a response to chemotherapy. Additionally, a Fast Track designation could bring this treatment option to even more patients soon.

Find the Right Mesothelioma Treatment for You

While researchers will continue to monitor the study participants in future phases of the trial, the significance of these results to mesothelioma patients can’t be understated.

If you or a loved one have been diagnosed with mesothelioma, our team may be able to help you:

  • Find mesothelioma doctors, cancer centers, or support groups nearby
  • Understand your treatment options as well as possible symptoms or side effects
  • Pursue mesothelioma compensation that can help you afford medical care and other expenses

A mesothelioma diagnosis can feel overwhelming, but you don’t have to go through this alone. Call (866) 608-8933 now to get help from our caring Patient Advocates.

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Laura WrightWritten by:

Lead Editor

Laura Wright is a journalist and content strategist with more than 15 years of professional experience. She attended college at the University of Florida, graduating magna cum laude with a bachelor’s degree in journalism in 2008. Her writing has been featured in The Gainesville Sun and other regional publications throughout Florida.

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  1. Sava, Jordyn. Targeted Oncology (February 2024). FDA Fast Tracks UV1, Ipilimumab, and Nivolumab in Malignant Mesothelioma. Retrieved February 5, 2024, from https://www.targetedonc.com/view/fda-fast-tracks-uv1-ipilimumab-and-nivolumab-in-malignant-mesothelioma
  2. Ultimovacs ASA. (2023, October 17). Ultimovacs Announces NIPU Results Presented at ESMO 2023: Significant and Clinically Meaningful Improvement in Overall Survival for Patients Receiving UV1 Cancer Vaccine in Phase II NIPU Trial in Malignant Mesothelioma. Retrieved February 5, 2024, from https://ultimovacs.com/investors/news/ultimovacs-announces-nipu-results-presented-at-esmo-2023-significant-and-clinically-meaningful-improvement-in-overall-survival-for-patients-receiving-uv1-cancer-vaccine-in-phase-ii-nipu-trial-in-mali
  3. Ultimovacs ASA. (2024, February 5). Ultimovacs Receives FDA Fast Track Designation for UV1 Cancer Vaccine for the Treatment of Patients with Unresectable Mesothelioma. Retrieved February 5, 2024, from https://ultimovacs.com/investors/news/ultimovacs-receives-fda-fast-track-designation-for-uv1-cancer-vaccine-for-the-treatment-of-patients-with-unresectable-mesothelioma

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