The revolutionary change in cancer treatment began in 2010 with the application of immunotherapy in the treatment of solid tumors, with excellent results to date, increasing the percentage of patients who are free of recurrence and/or cured.

The m-RNA platform

“By taking advantage of the m-RNA platform used in the vaccine against COVID-19 in the pandemic, the m-RNA cancer vaccine was developed and created for the first time, which was related to skin melanoma,” says Mr. Dimitrios Bafaloukos Oncologist-PathologistDirector of the 1st Oncology Clinic Metropolitan Hospital, University Professor Emeritus.

The first vaccine in Greece in a patient with melanoma took place on 17/1/2024 at the First Oncology Clinic of the Metropolitan Hospital, in Neo Faliro, with Mr. Bafaloukos as the main researcher. Since then it has been administered to many patients around the world, but also in Greece in four centers in the context of a phase III clinical trial.

Lung cancer

The m-RNA vaccine is now being tested in non-small cell lung cancer. Lung cancer is the leading cause of cancer death. In 2020 there were 1.8 million deaths worldwide, representing 18% of all cancer deaths. In Europe, lung cancer is the leading cause of cancer-related deaths, with 384,000 deaths per year.

The phase I clinical trial which is the first study developed by Biontech and called BNT 116, started in England and is being conducted in 34 research centers in seven countries: USA, England, Germany, Hungary, Poland, Spain and Turkey. A total of 130 patients will receive the vaccine: either in the early stage of the disease or before surgery or radiotherapy, or in an advanced stage of the disease or in recurrent lung cancer.

A phase III study is now being conducted in our country in non-small cell lung cancer stage II-IIIB (N2) with the m-RNA vaccine developed by Merck (MSD) and MODERNA and called V940 (m-RNA-4157) . Patients after surgery and adjuvant therapy will be randomized to receive V940 vaccine with or without immunotherapy. Approximately 900 patients worldwide will be enrolled (Interpath-002 study).

“The vaccine uses messenger RNA (m-RNA) similar to the COVID-19 vaccines that instructs the production and synthesis of specific proteins that are needed and essentially trains the immune system to fight cancer cells that express specific tumor antigens. It is noted that it leaves healthy cells intact and thus does not have the side effects of chemotherapy,” explains the professor.

The new era

So we are entering a very exciting new era of m-RNA vaccine-enhanced immunotherapy clinical trials, which will be applied to other solid tumors, such as pancreatic, urothelial, prostate, and other cancers.

It seems that soon the medical community will move forward in lung cancer in phase II and III studies and finalize the positive results with or without the combination with the immunotherapy used today, as is already done in cutaneous melanoma, where there are published very encouraging results of phase IIB study, where the chance of death was reduced by 62%. Final results are expected in hundreds of volunteer patients with operated melanoma who will complete the phase III study (1200 patients).

“The new era for Cancer treatment has already begun excitingly and gives rise to reasonable hopes for millions of people”, concludes Mr. Bafaloukos.