Lung cancer, new drug for non-smokers: AIFA’s yes to reimbursement

A new therapy for adults suffering from lung cancer, even if it concerns a limited number of patients, comes from the third generation drug lorlatinib, which manages to block the progression of the neoplasm in the presence of brain metastases for years. AIFA has authorized first-line reimbursement for this tyrosine kinase inhibitor, intended to treat advanced Alk-positive non-small cell lung cancer (NSCLC).

The neoplasm

As explained by Handlethis category of patients concerns the 5-7% of Nsclc casesthe most frequent histology in lung cancer, which includes in particular young people under 50 years of age, especially non-smokers, but not only, whose disease responds much less to standard chemotherapy (here we reported the boom in tumors among young people in the last 20 years).

“These patients are younger than average, mostly non-smokers and in good general condition, but with a high incidence of brain metastases“, up to 40 percent, as explained by Silvia Novello, Professor of Oncology at the Department of Oncology of the University of Turin and president of Walce Onlus.

“The central nervous system is for them a frequent site of disease progression – added the professor – therefore, the prevention of brain metastases during the first line of treatment has a fundamental role”.

The third generation drug lorlatinib was developed to overcome the blood brain barrier and therefore act at a cerebral levelbut also to counteract the disease in patients who have developed resistance against previous therapies.

As recalled by Corriere della SeraAIFA had already given the green light to the second line, or subsequent lines, for people who have already received specific treatments to which they no longer respond.

The numbers of lung cancers in Italy

In Italy, lung cancer is the second neoplasm in terms of number of diagnoses in men (15%) and the third in women (6%), as well as being the main cause of deaths among all forms of cancer (here we have reported the EU health spending on cancer treatment each year).

According to Aiom-Airtum data, they have been estimated in 2023 in Italy around 44 thousand new cases, mostly corresponding to Nsclc histology. Among the numerous molecular alterations that can determine the onset and development of neoplastic pathology, the alteration of the Alk gene represents an important therapeutic target (here we reported a study on the nutrients of milk and meat as allies against cancer).

As explained by Filippo de Marinisdirector of the Division of Thoracic Oncology of the European Institute of Oncology (Ieo) in Milan and president of the Italian Association of Thoracic Oncology (Aiot), the data from the Crown study “indicate that lorlatinib is more effective than the treatments that we have so far considered standard” .

“The trial – on which the AIFA authorization was based, as explained by the professor – involved 104 hospitals in 23 countries around the world, 296 patients and the advantages obtained are many: 72% of participants saw their brain metastases disappear and a further 10% still had an intracranial response; 64% of patients did not progress three years after starting lorlatinib (compared to 19% of those taking standard therapy until now); the side effects are well tolerated (especially increased cholesterol and triglycerides, with weight gain) and can be managed.”