Lytix Biopharma has announced the treatment of the first patient in its Phase II NeoLIPA clinical trial at Radiumhospitalet in Oslo, Norway. This study is designed to assess the efficacy of Lytix's lead drug candidate, LTX-315, in combination with pembrolizumab, for patients diagnosed with early-stage melanoma. Melanoma, a severe form of skin cancer, is witnessing a global rise in incidence, projecting a market value of USD 11 billion by 2030.
Trial Design and Objectives
The investigator-led trial, conducted by Oslo University Hospital (Radiumhospitalet), aims to enroll approximately 27 patients. The NeoLIPA trial, led by Dr. Henrik Jespersen, Head of Melanoma at Oslo University Hospital, will evaluate the combination of LTX-315 and pembrolizumab in a neoadjuvant setting, administering the treatment before surgical removal of melanoma lesions. Interim results are anticipated in H2 2025.
The primary endpoint of the trial is the pathologic complete response (pCR) rate, defined as the complete absence of cancer cells in tissue samples post-surgery. Secondary endpoints include time to recurrence and overall survival. The study seeks to determine if the combined neoadjuvant treatment of LTX-315 and pembrolizumab enhances the pCR rate and reduces melanoma recurrence.
Rationale for Combination Therapy
The rationale behind combining LTX-315 with pembrolizumab lies in LTX-315's unique mechanism of action. It can both directly kill cancer cells and stimulate the immune system to target cancer cells throughout the body. This dual action may synergize with pembrolizumab, a PD-1 inhibitor, to improve patient outcomes.
Dr. Jespersen stated, "Since LTX-315 address some of the shortcomings of PD-1 inhibitors we are excited to investigate the effect of LTX-315 combined the PD-1 inhibitor, pembrolizumab, before surgery in this patient population."
Unmet Needs in Melanoma Treatment
Despite advancements in melanoma treatment, recurrence remains a significant challenge, even after surgical removal of the primary tumor. There is a need for more effective therapies to address early-stage melanoma and prevent disease recurrence. The current standard of care involves PD-1 inhibitors for eligible patients, but LTX-315 offers a complementary approach that could potentially overcome some limitations of PD-1 inhibitors.
Market Potential
The melanoma treatment market is substantial and growing, projected to reach USD 11.0 billion by 2030, with an annual growth rate exceeding 10%. Over 300,000 new cases of melanoma are diagnosed annually, underscoring the importance of developing new and effective treatments to reduce the risk of recurrence and improve patient outcomes.
Dr. Øystein Rekdal, CEO of Lytix Biopharma, noted, "By expanding our clinical trials to early-stage melanoma patients we are adding to our robust portfolio of clinical studies...In addition, our treatment may provide several important advantages for this patient population."
