“The era of precision immuno-oncology begins: a new approach opened by the combination of two immuno-oncological molecules, nivolumab plus ipilimumab, which in an all-Italian study, for the first time in the world, was subjected to agnostic evaluation , ie regardless of the affected organ “. This was announced by Bristol Myers Squibb (Bms), which has promoted a virtual media tutorial to present the results of a meta-analysis coordinated by the La Sapienza University of Rome and published in the ‘Journal of Translational Medicine’. The work examined 7 studies conducted between 2010 and 2020 on more than 2,420 patients with melanoma, small cell and non-small cell lung cancer, bladder and stomach cancers, sarcoma and mesothelioma.
“The combination of nivolumab and ipilimumab – reads a note – has shown an agnostic efficacy, ie transversal and beyond the type of cancer. In particular”, the association “increased responses by 68% and reduced 20% risk of disease progression and 13% risk of death compared to monotherapy with nivolumab alone. Individual studies have also shown that long-term survival in several types can be achieved with the combination of nivolumab and ipilimumab of tumors that are particularly difficult to treat at an advanced stage, such as those of the lung (about 40,880 new cases estimated in Italy in 2020), of the kidney (13,520), melanoma (14,900) and mesothelioma (1,900) “.
“The synergistic effect of the two molecules is not merely additive, but allows a significant amplification of the responses, improving their speed, extent and duration – explains Paolo Marchetti, Director of Medical Oncology B of the Policlinico Umberto I in Rome, full professor of Oncology at Sapienza and first signature of the meta-analysis – This way it is possible to obtain a more consistent and rapid control of symptoms. Nivolumab plus ipilimumab is the first example of a combination of molecules that act in a complementary way on the immune system and that allow to achieve important clinical results “.
“This approach, based on the mechanisms of response and resistance – highlights the expert – represents a first step towards precision immuno-oncology, overcoming the model of medicine based on the stratification of patients based on predictive factors of response. the latest model is aimed at reducing the number of patients to be treated in order to obtain a clinically relevant advantage, while the agnostic model allows for the expansion of the number of patients who can benefit from a specific therapeutic modality “.
To date, the nivolumab-ipilimumab mix has shown and is demonstrating efficacy in different types of tumors – recall from Bms – and has received European approval in the first-line treatment of advanced melanoma, in the first-line treatment of advanced renal cell carcinoma intermediate / unfavorable risk and, in association with two courses of platinum-based chemotherapy, in the first-line treatment of metastatic non-small cell lung cancer (Nsclc) without Egfr and Alk mutation. “It is necessary that the combination be reimbursed also in Italy, as in other European countries – underlines Marchetti – in order to offer above all these patients an effective therapeutic alternative”.