Cancer Vaccine Candidate Combined with Checkpoint Inhibitors Reduced Death Risk by 27%

Ultimovacs ASA today announced the results from a phase 2 clinical trial for second-line treatment in patients with malignant mesothelioma.

The data presented as a late-breaking abstract at the ESMO Congress shows that Ultimovacs' cancer vaccine UV1, in combination with ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement of overall survival versus ipilimumab and nivolumab alone, a key secondary endpoint.

The UV1 cancer vaccination combined with ipilimumab and nivolumab reduced the risk of death by 27%.

"For patients with malignant mesothelioma, few treatment options are available after first-line chemotherapy. The NIPU study showed that patients receiving UV1 vaccination as an add-on to nivolumab and ipilimumab experienced an increased objective response rate and a clinically meaningful prolonged survival."

"These encouraging results provide a foundation for advancing further clinical development with UV1 vaccination in mesothelioma patients," said Principal Investigator of the NIPU clinical trial, Professor Åslaug Helland, MD Ph.D., in a press release on October 18, 2023.

UV1 is a therapeutic cancer vaccine that generates an immune response against the human telomerase enzyme.

The enzyme is essential for the ability of cancer cells to proliferate. Telomerase is present in 85-90% of all cancers across the stages of the disease. The vaccine is manufactured as an off-the-shelf product with a long shelf life. UV1 is easy to use and does not require sophisticated hospital infrastructure.

The results showed that UV1 plus ipilimumab and nivolumab improved overall survival (OS), reducing the risk of death by 27% (HR=0.73 [80% CI, 0.53-1.00]). The median OS was 15.4 months (95% CI, 11.1-22.6) for UV1 plus ipilimumab and nivolumab (treatment arm) versus 11.1 months (95% CI, 8.8-18.1) for ipilimumab and nivolumab alone (control arm), with a median observation time of 17.3 months. This degree of improvement met the protocol's predefined threshold for statistical significance.

The data further demonstrated a benefit in terms of objective response rate, as determined by a blinded independent central review. In the UV1 arm, 31% of the patients experienced an objective response compared to 16% in the control arm (odds ratio 2.44 [80% CI, 1.35-4.49]).

The safety profile of the combination of UV1 plus ipilimumab and nivolumab observed in the trial was consistent with the safety profile of ipilimumab and nivolumab alone, confirming the good safety profile for UV1.

The patients will continue to be monitored for efficacy and safety endpoints over the next years.

Malignant mesothelioma is an aggressive, complex form of cancer with a high mortality rate and few therapeutic options. Patients affected have often been occupationally or environmentally exposed to asbestos. Several efforts have been made in the last decades to improve the survival outcomes of patients with mesothelioma.

There is currently no established standard of care in second-line treatment.

In October 2023, Ultimovacs announced that the U.S. FDA had granted Orphan Drug Designation for UV1 to treat mesothelioma (based on the NIPU data from June 2023).

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biologies and disease stages, combined with different checkpoint inhibitors. 

The title of the late-breaking ESMO abstract is "LBA99 First survival data from the NIPU trial; A randomized, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second-line treatment in patients with malignant mesothelioma."

Oslo University Hospital sponsors the NIPU study with support from Bristol-Myers Squibb and Ultimovacs.