reimbursed in Italy for capmatinib, a new precision drug – breaking latest news

Another step forward to slow down the advance and improve the lives of patients with a particularly aggressive form of lung cancer: it has also been approved in our country by the Medicines Agency a new drug targeted against a rare genetic mutation (METex14) for which, until now, there were no specific treatments.

The therapy must also be chosen on the basis of the DNA

In recent years scientific research has made very important progress also against lung cancerwhich although it remains a tough nut to crack, has seen the survival of the sick lengthen more and more for years, stopping at a few months and which now, in an increasing number of cases, can be extended even for a few years. it is essential to know if and which genetic alterations are present within the neoplasm of each patient because it is precisely on the basis of the so-called “molecular profile” of the tumor that we can choose the most effective treatments on a case-by-case basis – remember Silvia NovelloProfessor of Medical Oncology at the University of Turin and Head of Pulmonary Oncology at San Luigi di Orbassano —. Already today around a third of lung cancers can be treated with an approach in the context of precision medicine: i.e. by searching for molecular targets for which targeted drugs have been developed. An important opportunity for patients, because using specific drugs has led to superior efficacy of treatments and better tolerability of treatments, guaranteeing long life expectancies for a disease that up until 15 years ago had a decidedly poor prognosis. Thus, in short, it was possible to gain months or years of life, against a neoplasm that in Italy has about 115 new cases every day. ALK, EGFR, KRAS, BRAF, ROS, RET, NTRK seem incomprehensible acronyms, which instead have a decisive value for patients: they are in fact the names of the genes that play a decisive role in lung cancer.

The METex14 mutation

Non-small cell lung cancer is a disease that can have several genetic mutations which is crucial to identify through correct molecular profiling at the time of diagnosis, to establish whether new drugs can be used that opened hopes that were unimaginable until a few years ago – he underlines Angelo Dei Tosfull professor of Pathological Anatomy at the University of Padua and director of the Department of Integrated Diagnostics at the University Hospital of Padua —. Unfortunately, however, diagnostic inhomogeneity persists in our country, although it should be emphasized that there is no shortage of centers of excellence capable of ensure immediate diagnosis and profiling. The METex14 mutation occurs in only 3-4% of patients, but now we finally have a new drug, capmatinib, which acts precisely on this specific target. The METex14 mutation promotes tumor growth and proliferation and represents a negative prognostic factorto which must be added the advanced age of the population involved: in fact the median age at diagnosis of 73.7 years old compared to 64.2 years of the population that does not have this mutation. In addition, patients with METex14 develop an aggressive form of the disease and manifest a high incidence of brain or bone metastaseswhich are associated with low survival and a significant impact on the quality of life.

Late diagnosis

I am 44 thousand new diagnoses of lung cancer every year in our country (non-small cell lung cancer accounts for about 80-85% of all cases), 34,000 deaths were recorded in 2022. More than 70% of patients discover the disease too late because the cancer is not gives obvious signs of its presence until it is already in an advanced stage,” he says Cesare Gridelli, director of the Onco-hematology Department of the Moscati Hospital in Avellino —. So, unfortunately, five years after the discovery of the disease, only about 18% of the patients are alive. Today, four out of ten people can access targeted therapies that improve the quality and length of life. The METex14 mutation then covers a particular importance because, unlike many of the mutations we know, expressed in good percentage also in smokers – continues Gridelli -. Furthermore, these patients show a high incidence of brain metastases, against which the new drug has shown a specific action.

New second-line drug

The efficacy and tolerability of capmatinib were evaluated in the multicenter (phase II) GEOMETRY MONO-1 study, which enrolled patients with MET-impaired non-small cell lung cancer into seven treatment groups, to which patients were assigned on the basis of line of therapy and type of MET impairment. The results of the study showed an objective response rate of 44% of cases and a median overall survival of 14.85 months. The GEOMETRY MONO-1 study highlighted the substantial, rapid and long-lasting antitumor activity of the drug – says Novello -. Furthermore, the results highlighted how the safety profile detected in all patients enrolled in the study is quite manageable. The new drug was approved for the subset of patients with the METex14 mutation after standard first-line treatment. Reimbursability in our country represents a great step forward for the scientific community which now has a new therapeutic weapon at its disposal for these patients who until now were treated on a par with patients without mutation, i.e. using immunotherapy and/or chemotherapy regimens, alone or in combination concludes the expert.