Ultimovacs ASCO Phase I data shows 60% ORR in advanced melanoma with UV1/pembrolizumab, supporting broad Phase II combination program
OSLO, Norway, June 04, 2021 (GLOBE NEWSWIRE) -- 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 onviction that UV1 can mobilize the immune system and play a transformative role in the treatment of solid tumors.”
Poster Presentation and Webcast
The oral presentation can be accessed on the ASCO website on June 4 at 9:00 am ET (15:00 CEST). The ASCO presentation is also available on the Ultimovacs website from 4 June 2021 at 15:00 CEST at: https://ultimovacs.com/
*Range reported in authoritative sources: FDA pembrolizumab packet insert; EMA pembrolizumab product information; Robert, C. et al (2019) Lancet Oncology 20, 1239-1251
About UV1 Clinical Programs
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Hans Vassgård Eid, CFO
Mary-Ann Chang, LifeSci Advisors