Evaxion Biotech A/S announced positive topline data from the ongoing Phase 2 trial of its lead cancer vaccine candidate, EVX-01, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced melanoma. The interim analysis revealed a 69% Overall Response Rate (ORR), with 11 out of 16 patients showing objective clinical responses.
The Phase 2 study (NCT05309421) is an open-label, single-arm, multi-center trial conducted across research centers in Italy and Australia. It aims to assess the efficacy and safety of EVX-01 in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma.
Key Findings from the Interim Analysis
The data indicated that 15 out of 16 patients experienced a reduction in their target lesions. These findings will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.
Christian Kanstrup, CEO of Evaxion, stated, “We are very excited about these data, which strongly support both the clinical profile of EVX-01 as a promising personalized cancer treatment and the unique predictive capabilities of our AI-Immunology™ platform… Huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could potentially be an improved treatment option for patients.”
EVX-01: A Personalized Approach to Cancer Immunotherapy
EVX-01 is a personalized peptide-based cancer vaccine designed using Evaxion’s AI-Immunology™ platform. This approach allows the vaccine to target the unique genetic makeup of an individual’s tumor, tailoring the treatment to the patient’s immune system. The goal is to enhance treatment efficacy and improve patient outcomes by mounting a targeted immune response against tumors.
Previous Clinical Data
In a completed Phase 1/2a clinical trial (NCT03715985), EVX-01 in combination with a PD-1 inhibitor demonstrated objective clinical responses in 67% of metastatic melanoma patients (8 out of 12), including two complete and six partial responses. The trial also showed vaccine-induced T cells in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions.
Melanoma Burden and Treatment Landscape
Melanoma accounts for approximately 1 in 5 of the 1.5 million new skin cancer cases estimated globally in 2020, with approximately 325,000 cases and 57,000 deaths. The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022). The global market for melanoma treatments is estimated to grow to $7.4 billion by 2029 (GlobalData).
