The news of the reimbursement approval by the Italian Medicines Agency for osimertinib in the adjuvant treatment of early stage non-small cell lung cancer arrived just as the Congress of the European Society of Medical Oncology (ESMO) is underway. (IB-IIIA) that has EGFR mutations. And right here at Esmo today, the updated results of the Phase III ADAURA study were presented which showed that this drug produced a clinically significant and sustained improvement in disease-free survival (DFS) compared to placebo.
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How survival is prolonged
Lung cancer is the leading cause of cancer death among men and women, accounting for about one fifth of all cancer deaths. About 30% of patients with non-small cell lung cancer are diagnosed with the disease early enough to undergo radical surgery, yet recurrence is still common in early-stage disease. Historically, about half of patients with stage I-II cancer and three-quarters of stage III patients have relapsed disease five years after surgery. Two years after the last follow-up in 2020, by giving all patients the opportunity to complete three years of adjuvant therapy, osimertinib reduced the risk of recurrence or death by 77% in patients with stage II-IIIA of the disease and 73% in the global study population. A median disease-free survival of approximately five and a half years (65.8 months) was observed in both osimertinib-treated patient populations. In the same patient populations, the median DFS of patients in the placebo arm was 21.9 months and 28.1 months, respectively.
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Effects on relapses on the central nervous system
The results of a further pre-planned exploratory analysis of the ADAURA study showed that osimertinib reduced the risk of central nervous system (CNS) recurrence by 76% in patients with stage II-IIIA cancer. At four years, 90% of patients in the osimertinib arm were brain disease free compared with 75% of patients in the placebo arm. Central nervous system disease recurrence is a frequent complication in patients with NSCLC and EGFR mutation and is associated with a particularly poor prognosis.
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An additional weapon in addition to traditional chemotherapy
The updated results of the ADAURA study therefore give new hope to these patients. “These data show that adjuvant treatment with osimertinib not only continues to prolong the disease-free survival of patients with early stage lung cancer with EGFR mutation after surgery, but over time also reduces the risk of recurrence at the level of of the central nervous system – explains Filippo de Marinis, director of the Thoracic Oncology Division of the European Institute of Oncology (IEO) in Milan and Principal Investigator of the ADAURA study for Italy. “These data confirm the use of adjuvant osimertinib as a standard of care for these patients, hitherto characterized by high relapse rates and lacking targeted therapeutic options after surgery. Even when the disease is diagnosed at an early stage, relapse rates after surgery remain high regardless of post-operative chemotherapy: nearly half of the patients receiving stage IB diagnosis and three-quarters of those in stage IIIA go meet a relapse within five years. The ‘traditional’ chemotherapy, in fact, fails to significantly impact the decrease in the risk of recurrence of local or distant disease in percentages higher than 5% “.
Aifa approval
A few days ago, the Italian Medicines Agency (AIFA) approved the reimbursement of osimertinib as an adjuvant treatment, i.e. after surgery, of early stage non-small cell lung cancer (IB-IIIA) that has EGFR mutations . “The results of the ADAURA study are unprecedented and led, in May 2021, to the European approval of osimertinib as an adjuvant for patients with early stage non-small cell lung cancer with EGFR gene mutations,” says de Marinis . “The benefits obtained, based on the updated results of the study, namely a 73% reduction in the risk of relapse or death in the global population and a median disease-free survival of about five and a half years, are truly significant and define a new standard of care, in the face of excellent tolerability. Thanks to the approval of AIFA, a real paradigm shift is taking place in our country as well, which sees the introduction of precision medicine in a population of patients where the intent of the treatments is the cure “.