It is called an agnostic approach and consists in studying a tumor from a biomolecular and genetic point of view to find out which mutations drive it and target them with targeted therapies. It does not matter in which part of the body the disease is. It works, and in some cases even very well. For tumors with Ntrk (Neurotrophic Tyrosine Receptor Kinase) gene fusion, therapy with larotrectinib is confirming expectations in terms of efficacy, safety and duration of response over time, with significant clinical benefits. Suffice it to say that in the case of salivary gland tumors the objective response rate (Orr) was 84% with an overall survival rate of 82% at 3 years, while in lung cancer the median survival reached 40. 7 months. The data were presented at the European Society for Medical Oncology (ESMO) Congress in Paris.
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As he explains Saverio Cinieri, president of the Italian Association of Medical Oncology (Aiom), agnostic drugs such as larotrectinib can be considered ‘wild cards’ because they selectively affect certain genetic alterations, regardless of the organ affected by the disease. The fight against cancer, in fact, is moving in that direction: from the affected organ to the molecular alterations – those that, if present, are sensitive to targeted drugs or immunotherapy. “Patients’ access to agnostic therapies begins with the execution of a genomic profiling test, continues with the interpretation of the data, to arrive at the therapeutic choice”, explains Cinieri. “The key point of the new process is represented by genomic profiling, ie the identification of the alterations that play a fundamental role in the development of neoplasms, defined as ‘drivers’. Hence the choice of the drug and the therapeutic indication, regardless of the location of the tumor “.
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A powerful weapon against Ntrk tumors
In this context, therapy with larotrectinib, a drug that blocks the action of chimeric Trk proteins that originate when the Ntrk gene fuses with another unrelated gene, is being distinguished for its results. These proteins are always active and favor the spread and growth of solid tumors in different parts of the body (for example lung, thyroid, gastrointestinal tract, central nervous system, salivary glands) in both adult and pediatric age. “Inhibition of chimeric Trk proteins with larotrectinib is very effective and leads to lasting responses regardless of the patient’s age and tumor location,” he reiterates. Carmine Pinto, director of the medical oncology of the Comprehensive cancer center Ausl-Irccs in Reggio Emilia and President of Ficog (Federation of Italian Cooperative Oncology Groups). “And this also in tumors for which the therapeutic expectations were very limited”.
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In lung cancer, for example, the median overall survival reached 40.7 months, while in the analysis of adult and pediatric cancers (excluding primary central nervous system) the median duration of response (Dor) was 34.5 months and in salivary gland cancer the objective response rate (Orr) was 84% with an overall survival rate of 82% at 3 years. In September 2021, the Italian Medicines Agency (Aifa) approved the reimbursement of larotrectinib for the treatment of neoplasms characterized by fusion of the Ntrk genes.
Hunting for mutations
For experts, the long-lasting efficacy and favorable safety profile observed with larotrectinib confirm the importance of tumor genomic profiling tests using Next Generation Sequencing (Ngs) technology to identify patients who may have important benefits. clinicians with drugs aimed at molecular targets, and therefore to be able to offer personalized therapeutic programs. “Guaranteeing access to NGS tests is essential to allow the use of these drugs”, concludes Pinto. “In our country, a governance of genomic tests and therefore of the network of molecular biology laboratories is essential, within the regional oncological networks, to ensure fairness in the use of these therapies. The financing of 5 million for 2022 and 2023 already provided for in the Budget law for the Ngs tests and the related Implementing Decree coming up, represent a first step in this direction “.