Lytix Biopharma, an immuno-oncology company, has announced the treatment of the first patient in its Phase II NeoLIPA trial at Radiumhospitalet in Oslo, Norway. The trial is designed to evaluate the efficacy of Lytix’s lead drug candidate, LTX-315, in combination with pembrolizumab, for patients with early-stage melanoma. This study marks a significant step in exploring new treatment avenues for melanoma, a skin cancer with a growing global incidence and a projected market of USD 11 billion by 2030.
Trial Design and Objectives
The investigator-led NeoLIPA trial, conducted by Oslo University Hospital, plans to enroll approximately 27 patients. Patients will receive a combination therapy of LTX-315 and pembrolizumab before undergoing surgical removal of their melanoma lesions. 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.
Rationale for Combination Therapy
The rationale behind combining LTX-315 with pembrolizumab lies in LTX-315's unique mechanism of action. It can kill cancer cells locally and activate the immune system to target cancer cells throughout the body. This dual action may synergize with pembrolizumab, a PD-1 inhibitor that enhances the immune system's ability to attack cancer cells. Dr. Henrik Jespersen, Head of Melanoma at Oslo University Hospital, 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 new therapies to improve patient outcomes and prevent disease recurrence. The combination of LTX-315 and pembrolizumab aims to address this unmet need by potentially preventing disease recurrence compared to the current standard of care.
LTX-315: A Novel Oncolytic Molecule
LTX-315 is a first-in-class oncolytic molecule that represents a new approach to boosting anti-cancer immunity. It is designed to work in various cancer indications and treatment settings, both as a monotherapy and in combination with other therapies. Lytix Biopharma currently has three ongoing Phase II studies, including trials in late-stage melanoma and basal cell carcinoma.
Market Potential
The market for melanoma treatment is substantial and growing. According to market analyses by Grand View Research, the melanoma treatment market is expected to reach USD 11.0 billion in 2030, representing an annual growth rate of over 10 percent. With over 300,000 new melanoma patients diagnosed each year, the need for effective treatments is critical.
