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with new therapy 88% patients alive at 5 years

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with new therapy 88% patients alive at 5 years

(beraking latest news) –
Novel therapy for early-stage EGFR-mutated lung cancer has achieved unprecedented survival in the disease with 88% of patients alive at five years. Positive results from the phase III Adaura study showed that osimertinib, the name of the drug being developed by AstraZeneca, produced a statistically significant and clinically relevant improvement in overall survival compared with placebo in the adjuvant treatment of non-small cell lung cancer ( Nsclc) in early stage (IB, II and III A) presenting epidermal growth factor receptor (Egfr) mutations, following radical resection. These are the results presented today at the 2023 Annual Congress of the American Society of Clinical Oncology (ASCO) and published simultaneously in The New England Journal of Medicine.

Osimertinib reduced the risk of death by 51% compared with placebo in both the primary analysis population (stage II-IIIA) and the overall study population (stage IB-IIIA). In the primary analysis population, 85% of osimertinib-treated patients are alive at five years compared with 73% of placebo-treated patients. In the overall study population, 88% of patients treated with osimertinib are alive at five years, compared with 78% of those treated with placebo. Median overall survival was not reached in both the experimental and control arms. Placebo-treated patients who developed metastatic disease had the opportunity to receive osimertinib as subsequent treatment.

“In the early stages of the disease, the intent of the treatment is curative – explains Filippo de Marinis, director of the Thoracic Oncology Division of the European Institute of Oncology in Milan and Principal Investigator of the Adaura study for Italy – Traditional chemotherapy is unable to have a significant impact on the reduction of the risk of local or distant disease recurrence in percentages higher than 5%. These new results from the Adaura study demonstrate that nearly 90 percent of patients with early-stage non-small cell lung cancer treated with osimertinib are alive at 5 years, with a 51 percent reduction in the risk of death. The relevance of these data is unprecedented: osimertinib is the first EGFR tyrosine kinase inhibitor to demonstrate an overall survival benefit in the adjuvant setting in patients with EGFR-mutated non-small cell lung cancer undergoing radical surgery. These results are even more important if we consider that, in operable disease, 5-year survival decreases from 73% in stage IB to 41% in IIIA. The benefit of osimertinib extends across all patient subgroups. Indeed, in stages II-IIIA, 5-year survival reached 85%. Adaura’s findings further reinforce the benefit of osimertinib as a standard of care after surgery in EGFR mutation-positive patients with early-stage disease.”

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“In 2022, almost 44 thousand new cases of lung cancer were estimated in Italy – says Saverio Cinieri, president of the Italian Association of Medical Oncology (Aiom) -. About 30% of patients with the non-small cell form are diagnosed early enough to undergo surgery with radical intent. Nonetheless, recurrence is still frequent in early stage cancer. For this reason we welcome the results of the Adaura study, further confirming the great progress that research in oncology is making. The role played by targeted and effective therapies such as osimertinib which actually lead to an improvement in the patient’s therapeutic pathway and increase the chances of long-term survival is important”.

“Surgery removes the carcinoma and cuts at the macroscopic level, but fails to affect the microscopic level – underlines de Marinis -. In other words, an ‘invisible microscopic’ remains represented by the micrometastases, which move in the blood and lymph and affect the local or distant relapse of the disease over time. About half of patients with stage I-II cancer and three-quarters of stage III patients recur five years after surgery. The availability of osimertinib makes it necessary to perform a molecular examination in all operated patients to verify the alteration of the Egfr gene, so that we can identify patients who are candidates for targeted therapy”.

At the previous analysis of disease-free survival, all patients had completed or discontinued treatment. The safety and tolerability of osimertinib at the extended follow-up was consistent with the established profile and previous analyses, with no new safety reports. Grade ≥3 adverse events from all causes occurred in 23% of patients in the osimertinib arm versus 14% in the placebo arm.

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Lung cancer is the leading cause of cancer death among men and women, accounting for approximately one-fifth of all cancer deaths. Lung cancer is divided into Nsclc and small cell lung cancer. It is estimated that every year, globally – concludes the note – 2.2 million people receive a diagnosis of lung cancer, of which 80-85% classified as NSCLC, the most common type. Most patients with NSCLC have a diagnosis of advanced disease, while approximately 25-30% have resectable disease at diagnosis. Diagnoses of early-stage lung cancer are often made only when the cancer is identified by radiological investigations done for other unrelated conditions. Most patients with resectable tumors recur despite complete tumor resection and adjuvant chemotherapy. Furthermore, only 73% of Stage IB patients and 56-65% of Stage II patients survive five years. The percentage drops to 41% in Stage IIIA patients, demonstrating a high unmet medical need.

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