World's second third-generation EGFR target son-in-a new drug Amatinib to market

Ametini listing siteto scientific and technological innovation to fill the gap in domestic three generations of EGFR target drugAmatini is the world's second and the first domestic three-generation EGFR target new drug, used to treat EGFR T790M mutation-positive treatment of local late or metastatic non-small cell lung cancerAs an iconic innovation of the output of major special support for science and technology, Ametini broke through the major technology of clinically urgent lying drugs, filling the gap of three generations of EGFR targeted drugs developed in China, and bringing long-term, high-quality survival hope for patients with advanced lung cancerchina's original new drug to bring new options for patients with advanced lung cancer
Amatini clinical trial of the main researcher, Shanghai Jiaotong University affiliated thoracic hospital Professor Lu Wei interpreted the Ametini I/II clinical research dataThe study showed that ametinib had very good efficacy in patients with advanced lung cancer who took a generation- and second-generation EGFR targeted drug with T790M-resistant mutations, with an objective remission rate of 68.9%, a disease control rate of 93.4%, and a median progression survival (mPFS) of 12.3 monthsAmetinib had a small side effect, few adverse events, and no patients were seen with interstitial pneumonia during the study period, which showed excellent performance in tolerance and safetyin addition, in response to the problem of poor brain transfer effect of a generation of targeted drug treatment, the study confirmed that Amatinib can break through the blood-brain barrier, effectively inhibit the brain lesions, effectively alleviate dysmorating patients with brain metastasis as high as 61.5%Professor Lu believes that Ametinib's clinical research is a milestone in the development of new drugs in China, and its approval will provide clinicians with new options of efficacy, safety and reachcontinue to promote the development of lung cancer medicine with patient-centeredthe listing of ametinib, alleviated the problem of drug resistance after treatment of advanced lung cancerOn the spot, 7 years of anti-cancer patient Liu Grandma shared her "road to fightcancer", diagnosed in 2013 with advanced lung cancer, 2015 disease progression found T790M drug-resistant mutation, but missed three generations of foreign EGFR-TKI clinical trials can only receive chemotherapy, in the drug accessibility, has been Unable to accept three generations of EGFR-TKI treatment, until the end of 2017 Amatinib began the first clinical trial recruitment, she participated in this trial, after a month of the drug the tumor was effectively controlled, but also significantly reduced, until now 2 and a half years, the disease is still in good control, Liu said, Ametini let her rekindle the love of lifein order to benefit more patients, the Weilan Public Welfare Foundation and Howson Pharmaceuticals jointly announced the establishment of the "Yulan Public Interest - Haussen Pharmaceutical Lung Lung Precision Medical Research Special Fund." Lu Aifeng, president of Haussen Pharmaceuticals, said that the fund is an effective practice for Howson to help the development of lung cancer medicine in China, aiming to encourage innovation, explore the best treatment options for three generations of EGFR targeted drugs, improve the clinical research capabilities of lung cancer specialists, and promote the improvement of China's medical and national health leveluphold the "do excellent national medicine, strong China to create" corporate mission, Howson Pharmaceuticals has always been to benefit patients as the center, will accelerate the pace of scientific and technological innovation, the introduction of more, newer, better drugs, in order to improve the health and quality of life of patients in China and the world, to contribute to China's original strength Ametinib Research recently announced the results of ametinib's main clinical study at arecentinny: AACR 2020: Hausson Pharmaceuticals Amatinib for EGFR mutation resistance in patients with NSCLC results published Ametinib II Clinical research is a single-arm, multi-center, open study of 244 patients in China who have advanced eGFR T790M mutation in the first/second generation of EGFR-TKI Patients take amatinib once a day to take 110 mg 244 patients, 63.5 percent were accompanied by 19 exon deletion mutations, 34.9 percent with L858R mutations, and 91 (37.3%) of patients had baseline without asymptomatic brain metastasis In 91 patients with baseline brain metastiability, 23 were evaluated in accordance with RECIST 1.1, and 23 cases of brain had measurable target lesions and included in the intracranial target lesions analysis set Figure 4 Ametinib Phase II study patient baseline characteristics efficacy with follow-up time reached 11.8 months, the overall population ORR reached 68.9%, DCR was 93.4%, the median DoR was 12.4 months, the median PFS reached 12.3 months, more than 1 year, which is also the third generation EGFR-TKI to date the longest second-line treatment mPFS in intracranial target lesions analysis, intracranial ORR is 60.9%, of which 1 patient reached intracranial full remission, intracranial DCR is 91.3%, intracranial median DoR is 11.3 months, intracranial median PFS up to 10.8 months In baseline brain metastasis patients (91 cases), the ORR was 63% Figure 5 The results of the Ametinib II study the above data show that amatinib not only had significant efficacy in the population as a whole, but also showed excellent efficacy in patients with brain metastasis In the KM graph, it can be seen that the two curves are close to each other, which also confirms the conclusion that amatinib's effect in the brain is basically consistent with that of the population in general Figure 6 The pfS graph of pfS in patients with ametinib safety drug-related adverse events was 75.8%, and the adverse events associated with drugs above level 3 were 15.6% (38 cases), of which 17 cases (6.9%) were elevated by hematine phosphosphatase (CK), and only 8.7% of the adverse events of level 3 and above associated with the study drug In terms of discontinuation, the proportion of discontinued treatment due to drug-related AE was 2.5% Figure 7 Ametinib II Study AE Incidence Phase II Studies The incidence of adverse drug events such as diarrhea, rash and itching in the Phase II study was around 10%, which was low in EGFR-TKI drugs clinicians are particularly concerned about the occurrence of interstitial pulmonary disease in the use of EGFR-TKI, and it is gratifying that 244 patients have not had mesothelial pulmonary disease at a follow-up time of 11.8 months Figure 8 The incidence of major AE in Ametinib II was 19.7% CK, mainly at level 1-2, and 6.9% at or above 3, without serious adverse events and termination of treatment CK elevation is mainly characterized by asymptomatic biochemical index abnormalities, reversible and manageable, without clinical significance of blood creatinine, hematura nitrogen and potassium Figure 9 Ametini II Study CK Incidence Author: MedSci Source: MedSci Original