The U.S. Food and Drug Administration has given fast-track designation to a promising new cancer vaccine used with nivolumab (Opdivo) and ipilimumab (Yervoy) in treating unresectable malignant pleural mesothelioma. The approval follows a recently completed phase 2 clinical trial that offered promising results.
Combination of Vaccine and Drugs Deliver Signs of Improvement for Mesothelioma Patients
Though malignant pleural mesothelioma is always considered a fatal diagnosis, patients whose tumors are eligible for surgical removal have hope for extended survival. But for those whose tumors are considered inoperable – or unresectable – there are few options. Vaccine developer Ultimovacs ASA has been working toward a solution that combines its UV1 vaccine with the FDA-approved immunotherapy combination of Opdivo and Yervoy.
A recently completed Phase 2 clinical trial assessed the safety and efficacy of UV1 with Opdivo and Yervoy as first-line treatment for mesothelioma in patients with unresectable disease, with promising results. According to Carlos de Sousa, chief executive officer at Ultimovacs, “UV1 demonstrated a positive safety profile and encouraging signs of improvement in overall survival [OS] in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need.”
Results from Mesothelioma Trial Drive FDA Fast-Track Status
In granting Fast Track status to the vaccine and immunotherapy combination, the FDA offers mesothelioma patients hope for greater access. The accelerated approval program was introduced by the agency in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. Approval relies on the presence of an indication being present at an earlier point in a trial than the type of endpoints used in a traditional approval.
The preliminary results of the Phase 2 mesothelioma trial were presented at the 2023 European Society for Medical Oncology Congress, revealing that at a median follow-up of 17.3 months, the median overall survival with UV1 plus nivolumab and ipilimumab was 15.4 months compared with 11.1 months with nivolumab and ipilimumab but without the vaccine.
If you have been diagnosed with malignant pleural mesothelioma and need information about access to clinical trials, the Patient Advocates at Mesothelioma.net can help. Contact us today at 1-800-692-8608 for more information.
