Professor JCO, Professor Zhou Caixuan, wrote that the efficacy of the second-line treatment of HER2 mutation SSCLC can be forsomed.

Recently, the results of a multicenter, open label, single arm phase II clinical trial with pyrrolidine as the main researcher, Professor Zhou caicun, Shanghai Lung Hospital Affiliated to Tongji University, was published online in JCO (Journal of Clinical Oncology), a top international academic journal.HER2 gene mutation accounts for about 1% - 2% in non-small cell lung cancer. It is a relatively rare tumor driving gene, and the insertion mutation of exon 20 is the most common.so far, chemotherapy is the main treatment for NSCLC patients with HER2 mutation, but the curative effect is not good, and the conventional anti HER2 targeted therapy has not shown ideal efficacy in such patients.pyrrolitinib is a pan erbB receptor tyrosine kinase inhibitor independently developed by Hengrui pharmaceutical, which can inhibit HER1, HER2 and HER4 pathways, and has been approved by the National Drug Administration (nmpa) for the treatment of HER2 positive breast cancer.in a small sample study involving 15 subjects, the orr of pyrrolotinib second-line and above treatment for HER2 mutant advanced non-small cell lung cancer reached 53.3%.in order to further verify its efficacy and safety in patients with HER2 mutation NSCLC, Professor Zhou caicun led this multi center phase II clinical study.from October 20, 2016 to December 10, 2018, a total of 60 patients with stage IIIB and IV NSCLC with HER2 exon 20 mutation (confirmed by central laboratory) and who had received at least one platinum based regimen chemotherapy were enrolled in this study.the primary endpoint was the objective response rate (ORR), and the secondary endpoints included safety, progression free survival (PFS), time to disease progression (TTP), duration of remission (DOR) and overall survival (OS).at baseline, 58 patients (96.7%) were in stage IV, at least 25 patients (41.7%) had received two platinum containing regimens in the past, and no patients had received immunotherapy.the results showed that the orr assessed by the independent review committee reached 30% (95% CI, 18.8% - 43.2%) as of June 20, 2019.all subgroups of patients with different HER2 mutation types showed good orr, and patients with or without brain metastasis showed similar orr (25.0% vs 31.3%).the median dor was 6.9 months (95% CI, 4.9-11.1 months), the median PFS was 6.9 months (95% CI, 5.5-8.3 months), and the median OS was 14.4 months (95% CI, 12.3-21.3 months).28.3% of patients had treatment-related grade 3 or level 4 adverse events, the most common was diarrhea, and no treatment-related death occurred.pyrrolitinib showed promising antitumor activity and good safety in the second-line treatment of HER2 mutant NSCLC.next, Professor Zhou caicun will continue to lead the international multi center, randomized controlled phase 3 clinical trial of pyrrolitinib in the treatment of advanced non-small cell lung cancer with HER2 mutation, and lead several international clinical centers including the United States, Europe, South Korea and Australia to carry out the collaborative work, expecting pyrrolitinib to reappear in NSCLC.References: caicun Zhou et al, pyrotinib in HER2 mutant advanced lung adenocarcinoma after platinum based chemotherapy: a multicenter, open label, single arm, phase II study.j Clin Oncol. 2020 Jul 2; jco2000297 doi:10.1200/JCO.20.00297.Online ahead of print.