Ultimovacs has clawed back confidence in its cancer vaccine candidate. Having missed the primary goal earlier this year, the Norwegian biotech has hit back with data showing that adding its vaccine to two Bristol Myers Squibb drugs improved survival in patients with cancer of the lung lining.
Investors fled Ultimovacs in June, when the biotech reported the failure of its cancer vaccine to improve progression-free survival (PFS) in second-line patients with malignant pleural mesothelioma. Adding UV1 to BMS’ Opdivo and Yervoy had no statistical effect on PFS and, as such, the trial missed its primary endpoint.
Ultimovacs kept tracking participants and has been rewarded by data that paint UV1 in a better light. The median overall survival (OS) in people who received UV1, Opdivo and Yervoy was 15.4 months, compared to 11.1 months in their control arm counterparts who only received the BMS drugs.
There is scope to question whether the OS improvement will hold up in a larger clinical trial. The 95% confidence intervals in the phase 2 study are wide and overlapping. In the treatment arm, OS could fall in the range of 11.1 months to 22.6 months. The range for the control group is 8.8 months to 18.1 months.
The abstract also contains data on the primary endpoint fail. PFS was numerically worse in the treatment arm, 4.2 months, than in the control group, 4.7 months, based on blinded independent central review. But relying on assessments from local investigators gave a different result. In that analysis, PFS for the study drug, at 4.3 months, beat the control's 2.9 months.
Ultimovacs said the overall data set supports further clinical development. The biotech could bolster or undermine that position in the coming months, with top-line results from phase 2 trials in melanoma and head and neck cancer on the roster for next year.
Shares in Ultimovacs jumped in response to the update, surging around 25% to 141 Norwegian kroner ($13). The boost sent the stock up above the price it commanded before news of the primary endpoint fail dropped in June.