Kurs & Likviditet
Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Bioteknik |
2021-06-04 15:12:37
o UV1/pembrolizumab results in 30% complete responses plus 30% partial responses
o Good safety and tolerability profile supports expanded Phase II combination
program
o Data highlighted at ASCO in poster presentation
Oslo, 4 June 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage
leader in immune stimulatory vaccines for cancer, announced that data on its
universal cancer vaccine, UV1, in combination with the checkpoint inhibitor
pembrolizumab will be presented as a poster presentation at the American Society
of Clinical Oncology (ASCO) 2021 Annual Meeting and available today at 9:00 am
ET / 15:00 CEST.
In a twenty patient cohort of patients with advanced melanoma, the combination
of UV1 with pembrolizumab as a first-line treatment demonstrated an objective
response rate (ORR) of 60% after a minimum of 18 months. Median observation time
was 21 months. In addition, 30% of treated patients achieved a complete response
(CR), with no signs of tumor detected. These response rates clearly exceed those
seen in previous studies for pembrolizumab alone in advanced melanoma of 33-37%
ORR and 5-12% CR*.
The median progression-free survival for the UV1/pembrolizumab combination in
the study was 18.9 months compared with the range of 5.5-11.6 months for
pembrolizumab alone*. The overall survival was 80%, with the median overall
survival yet to be reached after 21 months of follow-up.
The data also shows that the UV1/pembrolizumab combination is safe and well
tolerated, with adverse events largely restricted to low grade effects, mainly
injection site reactions.
Principal investigator and presenter of the ASCO data, Yousef Zakharia, MD,
Associate Professor of Medicine and Medical Oncologist at the University of
Iowa, commented: "These results are encouraging and warrant further
investigation. The trial gives a preliminary signal that UV1 vaccine has the
potential to increase efficacy and promote durable responses when combined with
checkpoint inhibitors and, more importantly, the combination seems to be safe
and well tolerable."
Ultimovacs continues to build on the safety and tolerability profile of UV1 with
several ongoing Phase I and Phase II clinical studies of UV1 in combination with
checkpoint inhibitors. In the Phase I UV1/pembrolizumab trial, data on a second
cohort of 10 patients (given a standard GM-CSF adjuvant dose of 75 µg, twice
that for cohort 1) will be reported when one year follow-up is complete in Q4
2021. Two year follow up on the first cohort will also be reported in Q4 2021.
Meanwhile, recruitment continues in Ultimovacs' expanding Phase II program of
randomized multinational trials of UV1 with checkpoint inhibitors in malignant
melanoma, malignant pleural mesothelioma, ovarian cancer and metastatic
head-and-neck cancer.
"These ASCO data from our Phase I trial in malignant melanoma represent the
moving edge of a much broader Ultimovacs clinical program on the safety and
effectiveness of UV1 used in combination with checkpoint inhibitors and other
therapeutic classes" said Carlos de Sousa, CEO of Ultimovacs. "Across a variety
of cancer types and with several different checkpoint inhibitors, we are
accumulating a growing body of evidence underpinning our conviction that UV1 can
mobilize the immune system and play a transformative role in the treatment of
solid tumors."
Poster Presentation and Webcast
Title: "A Phase I Clinical Trial Investigating the Telomerase Vaccine UV1 in
Combination with Pembrolizumab in Patients with Advanced Melanoma"