Unmet Medical Need
Disease Overview
Melanoma accounts for less than two percent of skin cancer cases but causes a large majority of the skin cancer deaths. More than 55,000 die from this disease each year on a global basis.
Melanoma is considered epidemic in the United States, Europe and Australia, with a doubling incidence every 10 to 20 years. It highly affects populations in regions with large amounts of sunlight and individuals with fair complexions. Sun exposure lifestyles and the continued use of tanning salons also contribute to the growth of this deadly disease that is now increasing at a faster rate than most other cancers. By 2023, it is projected there will be more than 200,000 new cases of melanoma per year.
Melanoma is staged in four segments, depending upon the spread of the disease. These include an initial skin lesion (stage I) to local lymph node involvement, followed by generalized lymph and distant organ infiltration by tumors (stages III – IV). For treatment purposes, the major segmentation is between disease suited for surgical resection and disease where systemic treatment is indicated (usually classified as stage IIB – IV). This is typically when the melanoma has metastisized, is unresectable or is at a high risk for spreading. SolaranRx is focused on the patient population requiring systematic treatment.
Treatment Challenge
Melanoma is generally resistant to chemotherapy, with low response rates and only a marginal improvement in disease outcome. Before the introduction of immunotherapies (CTLA-4 and PD-1 inhibitors) and targeted therapies (BRAF/MEK inhibitors) starting in 2011, patients with metastatic melanoma had poorer prognoses compared to patients with many other advanced tumors. The introduction of new agents has since considerably changed the disease management of unresectable and metastatic melanoma.
Unfortunately, despite the potential improved response offered by these new therapies, the majority of patients do not respond to these agents. Tumor Response rates for immunotherapies range from 11% to 40% for single and combination therapies. Targeted therapies for BRAF mutated melanomas have higher response rates; however, the duration of response has beenis limited due to the development of acquired drug resistance and the mutation only presents in about half of the patients. These patients and Non-responders have no further treatment options except largely ineffective and toxic chemotherapy regimens.