Lung cancer, AIFA approves the reimbursement of amivantamab
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According to official estimates, in 2022 alone there were over 40,000 new lung cancer diagnoses in our country. We are talking about one of the most frequent neoplasms both in men (second only to prostate cancer) and in women (third after breast and colorectal cancer). But we are also talking about a pathology that can present very different characteristics from patient to patient: non-small cell lung cancer (NSCLC, Non Small Cells Lung Carcinoma) is the most frequent and corresponds to almost 85% of new diagnoses. A first in Europe, Italy recently made reimbursable amivantamab, a monoclonal antibody developed to treat patients with advanced NSCLC who have rare epidermal growth factor receptor (EGFR) mutations – alterations that help cancer to spread rapidly and often make it resistant to treatment with other available therapies.
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That EGFR mutation
Lung cancer patients with specific EGFR mutations (in particular insertion mutations on exon 20, part of the gene that codes for the synthesis of the Egfr protein itself), have few therapeutic options available, both in number and in efficacy : “Just think – explains Filippo de Marinis, Director of the Thoracic Oncology Division and Deputy Director of the Lung Cancer Program at the IEO in Milan – that only 8% of people with this mutation survive 5 years after diagnosis. Specifically, the risk of disease progression is very high: we are talking about a 93% greater risk compared to the most common EGFR mutations”. Amivantamab is the first specific drug for patients with this type of lung cancer, and the approval for its reimbursement by AIFA therefore represents an important milestone. “Clinical studies conducted with this drug – continues de Marinis – have shown superiority over standard therapies for this tumor in terms of efficacy, allowing the life expectancy of patients to double”.
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Test patients for variants right from diagnosis
The non-specificity of symptoms, such as cough, fatigue, chest pain, dyspnea and weight loss, makes the diagnosis not always immediate: in fact, about 75% of patients with lung cancer are already in stage III or IV at the moment of the diagnosis. Prompt recognition of the type of mutation is therefore essential to follow the patient with the most appropriate therapy from the outset, and not only in subsequent lines of therapy. “Searching for and distinguishing the different variants is essential – explains Silvia Novello, professor of medical oncology at the Oncology Department of the University of Turin and president of WALCE, Women Against Lung Cancer in Europe -. Genetic tests, especially with Next-Generation Sequencing (NGS), prove to be a key tool not only for a correct diagnosis, but for a personalized therapeutic approach, also for EGFR exon 20 insertion mutations”.
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Data on the new drug
The efficacy and safety of amivantamab were evaluated in the CHRYSALIS phase 1 clinical study, in which the new drug was administered as monotherapy to patients previously treated with platinum-based therapy. 74% of patients demonstrated clinical benefit with a duration of response of 6 months or longer, and data demonstrated, on average, progression-free survival of 8.3 months and overall survival of 22.8 months. “We hope – concludes Bruno Aratri, president of the IPOP association, Together for Pulmonary Oncology Patients – that these innovative treatments, increasingly targeted and effective, will be made available quickly to all patients who need them” .
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