After more than a year of regulatory review, Argentina is now offering patients a domestically-developed vaccine for aggressive melanoma, the deadliest form of skin cancer. Known as Vaccimel, the immunotherapy-a first for the country’s advanced therapy production-is designed for patients with early-stage melanoma at intermediate to high risk of recurrence, and is distributed through specialized oncology channels. The breakthrough treatment, the result of three decades of research, is currently available at the Hospital de Oncología María Curie in Buenos Aires.
A new vaccine developed in Argentina to treat aggressive melanoma, the deadliest form of skin cancer, is now available to patients after more than a year of regulatory hurdles. The breakthrough is the result of over three decades of research by Argentinian scientists and marks the first advanced therapy – specifically, an immunotherapy – authorized for production within the country.
Known commercially as Vaccimel, this isn’t a preventative vaccine like those administered during routine checkups. Instead, it’s designed to treat melanoma cutaneo (cutaneous melanoma) in its early stages (IIB, IIC, and IIIA) for patients at intermediate to high risk of recurrence. The vaccine isn’t available through traditional pharmacies; it’s distributed through the same channels as other high-cost oncology medications, covered by individual patient insurance plans. A medical oncologist or skin cancer specialist must determine if a patient is eligible based on their tumor stage.
The complete treatment course spans two years, and the first medical center to offer Vaccimel is the Hospital de Oncología María Curie in Buenos Aires. This information was confirmed by the Laboratorio Pablo Cassará, the facility responsible for producing this novel cell therapy approved for melanoma in intermediate stages.
Treatment is administered under strict medical supervision in specialized centers. The laboratory reports the cost of Vaccimel is “comparable” to that of an available monoclonal antibody, which they note is “non-specific and with adverse effects.”
Melanoma cells possess antigens – proteins that signal a foreign agent causing disease and that the immune system should recognize and eliminate – that differ from those found in normal cells. However, these tumor cells develop mechanisms to evade the immune system and remain undetected. Vaccimel works by exposing the body to various tumor antigens through different clones of lymphocytes, essentially teaching the immune system to recognize and attack the cancer.
“The body begins to develop many clones that start to recognize different melanoma antigens: in more than 60% of patients, these clones are sufficient to prevent the disease from recurring,” explained José Mordoh, a researcher at the Conicet, in January. Mordoh’s team at the Cancerology Laboratory of the Fundación Instituto Leloir led the research that culminated in this therapy, a project supported by the Sales Foundation and Conicet. This long-term research paved the way for the vaccine’s development.
Initial projections estimated approximately 1703 new cases of skin cancer would be diagnosed annually in Argentina, considering all stages of the disease. Of those, 442 would be in the stages for which the vaccine is approved (17% in IIB and IIC, and 9% in IIIA). This suggests that around 100 patients could begin treatment with Vaccimel in the first year. Early detection through regular skin checks is crucial for identifying these cases.
The vaccine was initially expected to be available to healthcare centers in March 2024, then delayed to July 2024, before finally becoming available this month. The formal announcement of its market release occurred two weeks ago at the 74th Intensive Course of Improvement in Dermatology for Graduates Prof. Dr. Luis E Pierini, hosted by the Sociedad Argentina de Dermatología (SAD). The announcement was made during a presentation by Mario Marini, professor emeritus of Dermatology at the University of Buenos Aires.
Ana De Pablo, a dermatologist and member of the SAD, and associate chief of the Dermatology Service at Hospital Austral, emphasized that Vaccimel is not a preventative measure. “This isn’t a vaccine for people to get proactively,” she explained. “It’s for treatment in patients whose melanoma – perhaps due to its thickness or involvement of lymph nodes – carries a higher potential risk of developing lesions beyond the skin and lymph nodes, what we call distant metastasis.”
She further clarified, “We know that an adjuvant treatment could potentially prevent those metastases in the future.” Currently, there are two approaches to achieving this: traditional treatment and the mechanism of action of this vaccine. “What it tries to do is increase the patient’s immunity to attack tumor cells that may be hidden somewhere in the body,” said De Pablo, co-coordinator of the SAD’s 32nd National Skin Cancer Prevention Campaign.
According to De Pablo, the vaccine offers advantages including very few general side effects and the possibility of transitioning to standard treatment if it proves ineffective.
In summary, the dermatologist believes the new therapy is “a new therapeutic weapon that, in patients at higher risk of metastasis, could treat small pockets of cells that may be hidden and not yet detected.”
Ana Clara Acosta, also a member of the SAD and co-coordinator of the national campaign, is the head of the Oncological Dermatology Sector at Hospital Ramos Mejía. She stated that the newly approved vaccine by the Administración Nacional de Alimentos, Medicamentos y Tecnología Médica (ANMAT) would ideally “control” melanoma in patients with a high risk of recurrence or metastasis.
“These are patients in whom, after analyzing the clinical characteristics, how the cells are mutating, and many other factors, the tumor is defined and staged. They may not have metastasis or dissemination [of tumor cells], but they do have a high chance of developing it at some point in its evolution,” she described.
Acosta noted that previous chemotherapy treatments “haven’t had a good response recently,” leading to the development of new therapeutic approaches focused on enabling the immune system to fight tumor cells.
“The limitations of the vaccine are a bridge to the future for study. For example, seeing if it can be combined with some immunological treatment. Another option is to increase the group of patients who would be eligible to receive the vaccine. These would be patients with metastasis in another part of the body,” she proposed.
She explained that with these treatments, the goal is to extend life expectancy in these high-risk cases. Previously, with conventional chemotherapy, it was less than two years.
“With immunotherapy, this has changed a lot: today we have patients with high-risk tumors under control who are doing well after five or 10 years of follow-up,” Acosta emphasized. “The vaccine is an adjuvant therapy, meaning the patient receives the first-line treatment, which is always surgical, and the vaccine is added for high-risk patients. You don’t diagnose melanoma and administer the vaccine as the sole treatment. The correct path is to diagnose melanoma, operate, and if the patient meets the [clinical] requirements to be a high-risk patient, the vaccine can be indicated,” the dermatologist insisted.
The SAD’s annual campaign promotes monthly self-exams to identify any changes in moles or new spots on the skin. Dermatologists recommend using the following ABCDE rule for consultation if any changes are observed from month to month:
A: Analyze if they are asymmetrical
B: Check if their borders are irregular
C: Consider the color, if it is varied and if there are changes in color
D: Pay attention to the diameter and consult a dermatologist if it measures 6 millimeters or more
E: Study its evolution: does it cause itching, bleeding, or have scabs?
The SAD stated that the prognosis of skin cancer will depend on the affected cell, for example, with exposure to the sun without adequate protection or during the hours of greatest intensity of UV radiation (between 10 a.m. and 4 p.m.) as summer approaches.
“Melanoma represents approximately 5% of skin cancers and can be very aggressive, spreading to the lymph nodes or more distant organs. However, if detected early, it’s possible for a person to survive without future problems,” said De Pablo.
