(Adnkronos) – A greater than 80% reduction in the risk of disease progression or death in patients with aggressive, non-resectable stage III non-small cell lung cancer (NSCLC) in the advanced stage and with a mutation of Egfr gene. The result obtained with the targeted therapy osimertinib is among the data welcomed with most enthusiasm at the Congress of the American Society of Clinical Oncology (Asco), underway in Chicago. The study is called ‘Laura’ and was presented in the Plenary Session together with another trial, ‘Adriatic’, on the use of immunotherapy with durvalumab in limited-stage small cell lung cancer. In this case the mortality risk drops by 27%. Osimertinib – explains the Anglo-Swedish pharmaceutical group AstraZeneca in a note – is the first and only Egfr inhibitor and targeted therapy that shows a benefit in the setting of unresectable stage III, prolonging survival free from disease progression by more than 3 years (Pfs). In detail, the positive results of the phase III Laura study, published simultaneously in ‘The New England Journal of Medicine’, show that osimertinib produced a statistically significant and clinically relevant improvement in Pfs in patients with unresectable stage III NSCLC and Egfr epidermal growth factor receptor mutation – with exon 19 deletions or exon 21 mutation – after chemoradiotherapy (Crt), compared to placebo after Crt. Osimertinib reduced the risk of disease progression or death by 84% compared to placebo, as assessed by the independent scientific review board. Median progression-free survival was 39.1 months in patients treated with osimertinib, compared to 5.6 months in the placebo group. A clinically significant PFS benefit was observed across all pre-defined subgroups including sex, ethnicity, Egfr mutation type, age, smoking history, and prior CRT. Consistently, overall survival data showed a favorable trend with osimertinib, although not mature at the time of analysis. The study will continue to evaluate overall survival as a secondary endpoint. Filippo de Marinis, director of the Division of Thoracic Oncology of the European Institute of Oncology (Ieo) in Milan and president of AIOT (Italian Association of Thoracic Oncology), speaks of “extraordinary results”. Osimertinib produced “an unprecedented result” against the risk of disease progression or death, he points out. “Based on these data, osimertinib should become the new standard of care for these patients,” believes the specialist. “In this way – highlights Sara Ramella, director of Oncology Radiotherapy and full professor of Diagnostic Imaging and Radiotherapy at the Campus Bio-Medico University of Rome/Campus Bio-Medico University Polyclinic Foundation – we will be able to offer patients in a locally advanced stage a treatment targeted in a curative intent setting, capable of optimizing the effectiveness of chemo-radiotherapy, stage III of Nsclc is a complex setting – specifies the expert – which cannot ignore the involvement of a multidisciplinary team including a medical oncologist, surgeon and radiation oncologist for the adequate identification and correct management of patients”. As for the immunotherapy durvalumab – continues the note – in the phase III study Adriatic achieved statistically significant and clinically relevant improvements in the dual primary endpoint of overall survival and progression-free survival compared to placebo, in patients with limited-stage small cell cancer (Ls-Sclc) not progressing after the current standard of care of concurrent chemoradiotherapy. The results of the planned interim analysis show that durvalumab reduced the risk of death by 27% compared to placebo. Median overall survival was 55.9 months for durvalumab versus 33.4 months for placebo. 57% of patients treated with durvalumab are alive at 3 years, compared to 48% in the placebo group. Durvalumab also reduced the risk of disease progression or death by 24% compared to placebo. The median Pfs was 16.6 months for patients treated with durvalumab, compared to 9.2 months in the placebo group. An estimated 46% of patients treated with durvalumab had no disease progression at 2 years compared to 34% with placebo. The overall survival and progression-free survival benefit was consistent across key predefined patient subgroups, including age, sex, ethnicity, disease stage at diagnosis, prior radiotherapy, and whether prophylactic cranial irradiation was received. “It has been over 40 years since we have seen changes in the standard of systemic therapy for limited-stage small cell lung cancer – observes de Marinis – Adriatic is the first study to highlight progress with the addition of immunotherapy after traditional chemo -radiotherapy in these patients. The results represent a turning point for this highly aggressive disease in which recurrence rates are high, with only 15-30% of patients alive at 5 years. Durvalumab has already demonstrated a benefit in extensive-stage disease , progress in the limited stage is now important. Durvalumab is the first systemic therapy, after decades, to show an improvement in survival in these patients and should become a new standard of care in this setting.” “The results of the Laura and Adriatic studies highlight how innovative therapies can really change patients’ treatment prospects – comments Silvia Novello, president of Walce (Women Against Lung Cancer in Europe), professor of medical oncology at the University of Turin and head of Medical Oncology at the San Luigi Gonzaga hospital in Orbassano – More than one in 6 patients with non-small cell lung cancer is diagnosed with unresectable stage III disease and approximately 15% have the Egfr mutation patients eligible to receive targeted therapy with osimertinib, now also at this stage of the disease. On the other hand, small cell lung cancer has so far received less attention than other tumors, also due to social stigma, attributable to history. of smoking in the majority of patients. notable improvement in overall survival observed with durvalumab after concomitant chemo-radiotherapy is able to transform the treatment of the disease even in the limited stage, after the important results already demonstrated by immunotherapy in the extended stage”. —[email protected] (Web Info)
