Hans kommentar idag :
Significant survival improvement
Ultimovacs announced that its vaccine (UV1) combined with ipilimumab and nivolumab reduced the risk of death by 27% in the second-line treatment of patients with malignant mesothelioma. While no p-value was presented in the releasen late-breaking abstract, we expect (based on the wording of the result) a one-sided p-value below 0.1 (two-sided below 0.2) to be presented at ESMO on 21 October, thus showing significant results.
Significant survival data. The released late-breaking abstract 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]). While no p-value was presented in the abstract, we expect
(based on the wording of the result) a one-sided p-value below 0.1 (two-sided below 0.2) to be presented at ESMO on 21 October, thus showing significant results. We also note that while the confidence interval includes 1, based on the wording of the result, we believe the exactly number presented will be below 1. The median OS was 15.4 months (95% CI, 11.1–22.6) for UV1 plus ipilimumab and nivolumab versus 11.1 months (95% CI, 8.8–18.1) for ipilimumab and nivolumab alone, with a median observation time of 17.3 months.
NIPU turned out to be a success and warrants further investigation of UV1 in a large-scale
clinical trial of patients with malignant mesothelioma (Ultimovacs will most likely pursue further investigation in a first-line setting, due to the current treatment landscape). As we expected, the NIPU trial provided convincing survival data – the ‘gold standard’ efficiency measure, as it shows how long a patient lives. We also note that this adds to the evolving literature question ingen PFS as an appropriate surrogate endpoint for overall survival in immunotherapy. The NIPU trial is a randomised, open-label, multi-centre phase II trial with 118 patients conducted in Australia, Denmark, Norway, Spain, and Sweden. The first patient was enrolled in June 2020, and the last patient was enrolled in January 2023.
Adds confidence for Ultimovacs’s investment case. While the transferability of the
technology’s success in one study to another patient population should be seen with caution,
we believe these results are very positive for the UV1 vaccine in general, especially because
UV1 is demonstrating significant survival improvement in such a hard-to-treat indication as malignant mesothelioma.