Oslo, 7 February 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, presents long-term results from a clinical study with UV1 in combination with ipilimumab in patients with malignant melanoma at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, Florida.
In this clinical study where UV1 was combined with ipilimumab, overall survival was 50% after 4 years (6 out of 12 patients alive). This compares favorably to a similar phase IV study (IPI4) with ipilimumab alone which shows 4-year overall survival of 27.5%.
Combining checkpoint blockade with a therapeutic cancer vaccine may induce broader immune responses, leading to better clinical outcomes. UV1 targets the enzyme telomerase (hTERT) which is expressed in almost all cancer types and is essential for the immortality of cancer cells and a hallmark of cancer. UV1 consists of three synthetic long peptides and vaccination induces tumor relevant immune responses in most patients without any prescreening of patients required. This study explores the synergistic effect of CTLA-4 blockade (ipilimumab) and UV1 vaccination, allowing stronger expansion of hTERT-specific T cell clones.
In a phase I/IIa, single-center trial (NCT02275416) conducted at the Oslo University Hospital, Norway, patients with metastatic malignant melanoma received treatment with UV1 (300 g) + GM-CSF (75 g) as an adjuvant, combined with ipilimumab (3 mg/kg).
12 patients were treated from February to November 2015. Treatment was generally well-tolerated. Adverse events mainly included injection site reactions and diarrhea. Immune responses towards the UV1 peptides occurred very early and 10/11 (91%) of evaluable patients showed an immune response. With 4 years of follow-up, one patient obtained a complete tumor response and three patients obtained a partial response, resulting in an objective response rate of 44% based on 9 evaluable patients. The median progression free survival (PFS) was 6.7 months. Overall survival at 3 and 4 years was 67% and 50%, respectively. Although this study did not have a direct comparator arm, the results compare favorably to the ipilimumab monotherapy phase IV study at the Oslo University Hospital (the ‘IPI4 study’). The hospital enrolled 69 patients in the IPI4 study, with the same investigators, during the same time period and with similar inclusion criteria as Ultimovacs’ phase I study. The IPI4 study had a 4-year overall survival of 27.5%, which is consistent with survival data in the major historical ipilimumab studies.
In conclusion, combining UV1 and ipilimumab is safe and induces favorable clinical responses in melanoma. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism between UV1 and ipilimumab. Response rates and overall survival compare favorably to the IPI4 study and relevant historical controls. The results warrant further investigation of UV1 in combination with immune checkpoint blockade in malignant melanoma.
Detailed results from the study will be presented on 7 February 2020 during a poster presentation at ASCO-SITC 2020 by Espen Basmo Ellingsen MD. The poster (ID: 62, board C9) is titled “A phase I/IIa clinical trial investigating the therapeutic cancer vaccine UV1 in combination with ipilimumab in patients with malignant melanoma: Four-year survival update”.
The poster is available at www.ultimovacs.com.
For further information, please see www.ultimovacs.com or contact:
Øyvind Kongstun Arnesen, CEO oeyvind.arnesen@ultimovacs.com, +47 469 33 810
Hans Vassgård Eid, CFO hans.eid@ultimovacs.com, +47 469 19 822