2023-04-19 15:05:03
The data of an innovative strategy that combines immunotherapy and a “personalized” mRna vaccine, i.e. created by the tumor removed from the individual patient, were presented in Florida. How it works, why it’s promising and why caution is needed
It was 2011, when with great enthusiasm of the experts during the annual congress of the American Society of Oncology (ASCO) they were announced the first data on immunotherapy in patients with cutaneous melanoma. This tumor then paved the way for this new strategy which aims to stimulate the patients’ immune system against neoplastic cells and which today gives important results in many neoplasms for which there was little hope. A story that seems to repeat itself with the arrival of mRna vaccines (developed in record time against Covid) and which are now starting to give encouraging results also in the fight against cancer, in particular in the melanoma. Among the first results that demonstrate the usefulness of the mRna approach in the treatment of tumors, there are those of the Keynote 942 study, just presented in the United States during the congress of the American Association for Cancer Research (Aacr), underway in Orlando .
How mRna vaccines against cancer are born
“To better understand the novelty, we need to look at where we started from – he explains Paolo Asciertodirector of the Oncology, melanoma, oncological immunotherapy and innovative therapies unit at the Istituto Tumori Pascale in Naples —: before the arrival of immunotherapy in 2011, the life expectancy of patients with metastatic melanoma was about six months why chemo or other strategies against this cancer don’t work. Today we have several effective immunotherapy drugs and, in many cases, we can say that we have managed to make the disease chronic: in fact, half of the metastatic patients are still alive seven and a half years after diagnosis. However, we are looking for further solutions for those people who do not get the desired results with immunotherapy. This is how the experiments conducted using mRna vaccines are born, created with the aim of stimulate the production of antibodies and immune cells capable of recognizing particular proteins placed on the surface of cancer cells only to destroy them. Let me be clear, though: although the experts call it a vaccine, it is not a preventive strategy as the one for Covid-19 actually is which immunizes against the disease (and as happens with vaccines today against many diseases).
It is built starting from the tumor of each patient
The new mRna-4157/V940 it is a therapeutic vaccine, for people who are already ill: «In practice, a piece of tumor tissue removed from the patient is taken and sent to a specialized laboratory where it is “processed” – clarifies Ascierto -: a particular algorithm at this point selects several neoantigens (ie molecules recognized as “foreign” by the body and typical of that particular tumor and that particular person), choosing those that could generate a greater immunological response. On these, the messenger RNA is “constructed” and becomes the actual vaccine inoculated into the patient. The immune system is then trained to recognize the cancer cells as foreign and to fight them. It’s a personalized treatment.” And it is a model (whose costs could be very high) in the future potentially exportable to other neoplasms as well.
The results of the new study
Specifically, the phase two Keynote 942 study enrolled 157 patients with stage III/IV melanoma who had had their tumors completely removed. Following surgery, 107 participants were treated with the experimental vaccine (for now identified with the acronym mRna-4157/V940), combined with the immunotherapy drug pembrolizumab and 50 with pembrolizumab alone. All were then followed up for two years. «The combination showed a statistically significant reduction in the risk of recurrence or death by 44% – says the expert -. Furthermore, the toxicity profile of the combination is good, very similar to that of monotherapy. There fatigueor chronic fatigue, is the side effect most associated with the vaccine. In addition to survival, the combination prolongs relapse-free time compared to monotherapy: at 18 months, 78.6% of patients in the combination group had not relapsed, compared with 62.2% of those who took pmbrolizumab alone ».
Caution and next steps
Despite the promising results, it is the experts themselves (starting with Jeffrey Weber, a researcher at New York University who presented the study at the Aacr conference in Florida) who call for caution: it is a phase 2 trial on a few patients, one in which testing the safety and efficacy of a new medicine, therefore we have to wait for the indispensable confirmations on larger numbers of people, followed for a longer period of time. «Phase 3 trials will soon start in Italy too (the last one before approval and entry on the market) – concludes Ascierto -. And further combinations of immunotherapy and therapeutic mRna vaccines are being studied. We are participating in one of these, conceptually very similar, as the Pascale Institute, with the vaccine being administered as a treatment in patients with ongoing metastatic disease. In particular, the anti PD-1 drug is used immediately and subsequently, after the eight weeks necessary for its preparation, an mRna therapeutic vaccine».
April 19, 2023 (change April 19, 2023 | 15:05)
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