On September 7-10, 2019, the 20thWorld Conference on Lung Cancer (WCLC)was held in Barcelona, Spain. On the morning of September 8, local time, Professor Lu ShunWeifrom Shanghai Chest Hospital reported the latest results of 「Research on the efficacy and safety of osimertinib inthe EGFR T790M mutation-positive locally advanced or metastatic NSCLCwith positive EGFR T790M mutation in the first/secondsecond-generationof EGFR TKI treatment progress」, and theresearchresultsin terms ofefficacy and safetywhichhave attracted widespread attention on the efficacy and safety.
Lung cancer is one of the fastest growing malignant tumors within terms of morbidity and mortality. More than 40%of patients in China are non-small cell lung cancer (NSCLC) patients with EGFR gene mutations [1]. These patients are currently mainly treated with first- and second-generation EGFR inhibitor (EGFR-TKI)-based targeted drugs, which have obvious advantages over traditional chemotherapy, but drug resistance and disease progression will occur after 1-2 years, of which more than a half is caused by T790M mutation [2]. Osimertinib is a new third-generation EGFR-TKI researched and developed by Hansoh Pharma with independent intellectual property rights [3], which can irreversibly and selectively inhibit EGFR-sensitive mutations and EGFR T790M-resistant mutations. Through the innovative design of the drug structure,it can avoid the generation of non-selective metabolites are avoided,andbreak through the blood-brain barrieris more easily broken, which is stillremainingeffective for patients with brain metastasis. Preclinical and clinical Phase I studies have demonstrated that osimertinib is effective and has mild skin and gastrointestinal toxicity [4].
In thehis report at this conference, Professor Lu introduced the latest results of Phase II clinical trials of osimertinib [5]. The study included 244 subjects from Chinese Mainland and Taiwan with a median treatment duration ofduration of treatment for9.5 months (up toas ofMay 25, 2019), and assessed. According to the assessment by an independent review committee, the objective response rate (ORR) and disease control rate (DCR) of osimertinib monotherapy were exciting, showingthe excellent drug resistance mutation inhibition effectinhibition effect of drug resistance mutations; Thethe ORR subgroup analysis showed that osimertinib was effective in all subgroups of patients, and good treatment results were also obtained in patients with brain metastases; Thethe common adverse reactions in the study were tolerable, and wereatclinically controllable level 1 or 2,and the incidence of level 3 and above adverse reactions, reduction anddiscontinuation ratesof discontinuation for adverse reactions of Level 3 and above were low. No, and no patients developedinterstitial lung diseaseoccurred during the study. In the post-conference reviewpartDuring the comment after the conference, internationally renowned experts such asPaul,the founder ofthe WCLC and chairman ofseveral consecutive WCLCs Paulfor several consecutive sessions, and Robust,thea famous Spanish expert,Robustand other internationally renowned expertshighly praised the research results of osimertinib and its comparability withcomparable efficacy oversimilar international advanced drugs in terms of efficacy.
The application forthe new drug marketing of osimertinib was accepted by the CDE in April 2019, and was given aincluded in thepriority review by the CDE in May with afor its「significant therapeutic advantage over existing treatments」. It is noteworthy that the latest data indicatesshow that the progression-freeprogress freesurvival (PFS) benefits are significant and the tumor treatment response has a longer duration of maintenance. The approval of the drugfor marketing will fill the blankgap ofthe third-generation EGFR-TKI independentlyresearched and developed in China, providing clinicians with a highly efficaciouspowerful, safe and new choice to benefit more patients with non-small cell lung cancer.
It is also known that a Phase III clinical study evaluatingofthe efficacy and safety of osimertinib compared with gefitinib in the first-line treatment ofpatients with advanced NSCLC patients with EGFR-sensitive mutations is currently underway, and it is expectedwe expectthat the results of this study will bring hope forlong-term, high-quality survival togivemore advanced NSCLC patients the hope of long-term survival and high quality of survival.
References:
1. Lung Ccancer. Chinese translation, of the original, 4th edition. Beijing Science Press, 2013: 437.
2.Yu HA, et al. Clin Cancer Res. 2013;19:2240-2247.
3.ZL201580045311.2
4.P1.01-62 - The Third Generation Irreversible EGFR Inhibitor HS-10296 in Advanced Non-Small Cell Lung Cancer Patients, 2017IASLC.
5.LuS,WangQM,Zhang GJ,et al.The Third Generation EGFR Inhibitor(EGFR-TKI)HS-10296 in Advanced NSCLC Patients with Resistance to First Generation EGFR-TKI[EB/OL].WCLC 2019,abstract OA02.03.
