|Ultimovacs Announces Positive Three-Year Results of 71% Overall Survival Rate in Cohort 1 of UV1-103 Study in Metastatic Malignant Melanoma|
|By: GlobenewsWire - 05 Oct 2022||Back to overview list
Oslo, 5 October 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced continuing positive efficacy data in its ongoing U.S.-based phase I clinical trial, UV1-103. The study evaluates the Company's universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in advanced non-resectable and metastatic malignant melanoma patients.
“Given the historic trajectory for patients with metastatic malignant melanoma, this three-year 71% OS rate is very positive,” said Carlos de Sousa, CEO of Ultimovacs. “Overall, these promising data support our continuing belief that UV1 can play a transformative role in treating solid tumors in combination with checkpoint inhibitors, providing long-term clinical benefits for patients with unmet medical needs.”
After the study ended at two years follow up, the protocol was amended to follow patients for overall survival for up to five years. Three of the patients, all in cohort 1, did not consent to further follow up, changing the number of participating patients in cohort 1 from 20 to 17 after two years. In addition, one patient died within the past year.
At the three years cut-off date for patients in the first cohort the three-year overall survival (OS) rate was 71% (12/17). The trial has shown a consistently high OS rate; in this patient cohort it was 85% (17/20) after one year and 80% (16/20) after two years follow-up. Having already reached its primary endpoint of safety and tolerability, the UV1-pembrolizumab combination continues to demonstrate strong signals of clinical efficacy in both response rates and extended survival.
Pembrolizumab is a standard of care for patients with unresectable or metastatic melanoma, based on data from the KEYNOTE-006 trial*. Follow up of first-line patients with metastatic melanoma in that trial showed an overall survival rate of 51% at 36 months.**
“The high survival rate after three years for metastatic malignant melanoma patients is very encouraging and reinforces the positive data we have consistently observed throughout the UV1-103 trial,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “As previously reported, the combination of UV1 and pembrolizumab has a strong safety and tolerability profile. These three-year data also signal that UV1 continues to mobilize the immune system providing patients with a long-term, effective clinical response. We are very pleased to see the positive results for these patients.”
UV1-103 (Cohort 1) Overall Survival Rate % (Patients alive/total):
Further data from the UV1-103 study will be presented at the International Congress of the Society for Melanoma Research, October 18, 2022.
*For reference only; not a head-to-head comparison
About the UV1-103 phase I trial in Malignant Melanoma
This US-based Phase I clinical trial is evaluating the Company’s lead candidate, UV1, in combination with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with metastatic malignant melanoma. The trial is evaluating the safety, tolerability, and initial signs of clinical response. The 20 patients in the first cohort received a 37.5 µg GM-CSF adjuvant dose per UV1 vaccination. The 10 patients in the second cohort received the standard 75 µg GM-CSF adjuvant dose per UV1 vaccination. The study has completed the enrollment of 30 patients, as announced on August 18, 2020. All included patients received the drugs as first line treatment for advanced and metastatic melanoma.
Compiled clinical results for the 30 patients enrolled are:
Patients will continue to be followed up long-term for survival. The trial had previously reached its primary endpoint of safety and tolerability, and no unexpected safety issues related to UV1 have been observed in this trial. Three-year of follow-up data on cohort 1+2 will be available in the second half of 2023.
The U.S. Food and Drug Administration (FDA) granted a dual Fast Track designation for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment of patients with unresectable or metastatic melanoma in the phase II study INITIUM.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Anne Worsøe, Head of Investor Relations
Mary-Ann Chang, LifeSci Advisors
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.
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