Adnkronos Roma, 18 mar. (Adnkronos Salute) – Un mix di 9 batteri intestinali, selezionati tra le oltre mille specie del microbioma, potrebbe migliorare l’efficacia dell’immunoterapia contro il melanoma avanzato resistente. Lo verificherà 'Melody-1', studio internazionale che coinvolgerà decine di pazienti provenienti da 18 centri tra Regno Unito, Francia, Spagna e Italia. Il primo paziente a ricevere il nuovo trattamento è in cura presso l’Istituto Nazionale Tumori Irccs Fondazione G.
Pascale di Napoli, uno dei centri coinvolti nello studio 'Melody-1' sotto la guida di Paolo A. Ascierto, presidente di Scito (Società Campana di Immunoterapia Oncologica) e della Fondazione Melanoma. A fare il punto su questa nuova linea di ricerca sono stati gli esperti recentemente riuniti a Napoli, proprio in occasione del meeting annuale di Scito, con l’obiettivo di fare il punto sulle ultime novità nell’immuno-oncologia. Tra queste una nuova linea di ricerca che punta a utilizzare il microbiota intestinale per offrire ai pazienti con melanoma metastatico, che non rispondono all’immunoterapia, una nuova opzione terapeutica.
“In recent years, it has become increasingly clear that the intestinal microbiota, in addition to playing a crucial role in food digestion and protection from infections, also interacts closely with the immune system,” explains Ascierto, who also directs the Melanoma Oncology, Oncologic Immunotherapy and Innovative Therapies Unit at the Pascale Institute in Naples. “Previous studies have led to the identification, in healthy people and in cancer patients who respond to immunotherapy, of 9 specific intestinal bacteria that, combined together, have led to the creation of a new ‘live biotherapeutic product’, renamed MB097, which will be tested in the Phase I clinical study, Melody-1.”
In particular, MB097 will be administered once a day orally in combination with pembrolizumab, a drug that falls into the category of immune checkpoint inhibitors, drugs aimed at eliminating the 'brakes' that prevent our immune system from attacking the tumor. "In the MELODY-1 study, all patients will receive MB097 and pembrolizumab for a maximum of 6 months," continues Ascierto. "Before starting therapy, half of the patients will also receive vancomycin, an antibiotic known to reduce intestinal bacterial flora, which will allow us to understand whether it can promote the attachment and growth of bacterial strains. At the end of the first 6 months, patients who benefit from the treatment will be able to continue receiving pembrolizumab for another 18 months, so about 24 in total."
In addition to evaluating the safety and tolerability of the new therapy, the trial will also measure the efficacy of standard oncology treatment, the engraftment of the strains and changes in the various immune biomarkers. "There is strong evidence that MB097 can induce the microbiome to increase the response of patients to immune checkpoint inhibitors," adds Margaret Ottaviano, medical director of the Melanoma Immunotherapy and Innovative Therapies Unit, also at Pascale, president of Scito Young and organizer of the meeting. "Preclinical studies have shown that MB097 is able to activate cytotoxic T lymphocytes and Natural Killer cells, the 'soldiers' of our immune system, so that they are able to attack and kill tumor cells. Furthermore, research has indicated that the 9 bacteria in MB097, in addition to activating the immune response, promote the production of metabolites that act directly at the tumor site."
If the study yields the desired results, we could be looking at a paradigm shift for patients with advanced melanoma. “Given that currently more than half of melanoma patients treated with immunotherapy do not respond or recur, our hope is that the addition of a precision therapy targeted to the microbiome could improve the chances of cure for these patients as well,” concludes Ascierto.