IO Biotech Announces Late-Breaking Oral Presentation of Phase 2 Clinical Melanoma Data Including Complete Response (CR) Rate of 45 Percent
IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win® technology, today announced a late-breaking, oral presentation of best-in-class efficacy data in first line melanoma for its cancer vaccines, IO102 and IO103 in combination with anti-PD1, nivolumab.
– Data to be Presented at the ESMO Virtual Congress 2020
– Melanoma trial (MM1636) shows best-in-class efficacy data in first line melanoma of IO102 and IO103 in combination with nivolumab (anti-PD1 antibody)
Copenhagen, Denmark – September 18, 2020
According to the abstract, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in peripheral blood mononuclear cells (PBMCs) and at the tumor site. These data will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 by Professor Inge Marie Svane, MD, Copenhagen University Hospital, Herlev. The abstract was published today online via the ESMO website (presentation number LBA48).
As of the data cut-off in August 2020, 30 patients were enrolled with a median follow up time of 15 months. One patient is pending first evaluation, 29 were evaluated, and by investigator review per RECIST v1.1, an ORR of 79 percent was reached; ORR was 94 percent and 62 percent in PD-L1 positive and negative patients, respectively. At data cut-off, 45 percent had reached a complete response and 34 percent achieved a partial response, which was significantly higher than a matched control group extracted from the Danish Metastatic Melanoma Database receiving anti-PD-1 monotherapy treatment as standard of care. The median progression free survival (mPFS) was 25.6 months. Except for local reactions at the vaccination site, toxicity was comparable to patients receiving nivolumab monotherapy. Vaccine specific T-cells against either IDO and/or PD-L1 were detectable from all treated patients in PBMCs and in several patients’ tumor sites where a biopsy was feasible. Preliminary results from tumor immune contexture analyses were also indicative of response.
“These early results are extremely encouraging and point toward a significant advantage of adding the vaccine to standard anti-PD1 therapy,” said Professor Inge Marie Svane, MD, Director at Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital Herlev, Denmark. “Not only have we seen almost twice as many patients benefitting from the treatment as expected, but it is also important to note that the combination was very well tolerated by the patients.”
“We are very pleased that the MM1636 study is selected as a late-breaking abstract at ESMO,” said Mai-Britt Zocca, PhD, Chief Executive Officer and founder at IO Biotech. “There is a high unmet need for a more effective treatment for melanoma patients, and our data demonstrate clearly our anticipated hypothesis of our T-win compounds to add additional efficacy to anti-PD1 treatment without any observed safety concerns.”
Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech
E-mail: mz@iobiotech.com
Media Inquiries
Jennifer Williams, Cook Williams Communications, Inc.
E-mail: jennifer@cwcomm.org