Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly

Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. 

When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%.  

Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. The addition of the vaccine added no toxicities to patients. The trial included 118 patients randomized 1:1 into the two treatment arms. 

In June, Ultimovacs had reported disappointing results from an independent review that the vaccine did not meet the primary endpoint of its Phase II study for progression-free survival (PFS). The biotech pointed out an investigator assessment of the primary endpoint did show a statistically significant positive PFS benefit in the UV1 arm, sending the stock tumbling over 30% at the time. 

The new data has helped to reassure investors, bringing the company’s stock price up around 25% this week. Ultimovacs contends the “data supports further development in mesothelioma” and will be discussing the results with regulatory authorities, CEO Carlos de Sousa said in a statement. The company also said the results will be presented later this week at the ESMO Congress 2023 in Madrid, Spain.

The FDA has granted Orphan Drug Designation for this indication. 

UV1 is designed as a universal cancer vaccine, consisting of a tumor-associated antigen found in almost all cancer types. In addition to mesothelioma, it’s also in Phase II trials combined with one or more checkpoint inhibitors for ovarian, non-small cell lung cancer as well as head and neck cancers. 

New data was also announced this week for UV1 as a first-line treatment when combined with Keytruda for advanced non-resectable and metastatic malignant melanoma. The combo resulted in 33% complete responses and extended overall survival of 87% after one year. This indication received Fast Track Designation from the FDA in 2021. 

Published: Oct 18, 2023 By Kate Goodwin