A retrospective study of effectiveness and safety of Nivolmab for advanced or recurrent NSCLC harboring EGFR mutation

Abstract

Some clinical studies showed the effectiveness of immune-checkpoint inhibitors for various kinds of cancers. Checkmate 057 was planned to compare OS between patients who received Nivolumab or Docetaxel in previously treated advanced non-squamous NSCLC. Patients with Nivolumab showed longer OS and reported fewer severe adverse events. However, subgroup analysis revealed poorer survival with Nivolumab among EGFR mutation positive patients. Few report has assessed the safety and effectiveness of Nivolumab for EGFR positive patients. Some clinical reports informed interstitial lung disease (ILD) by EGFR-TKI following Nivolumab. It is not well known whether this treatment sequence might increase the incidence of ILD. Now we planned a multiinstitutional joint research to investigate the safety and effectiveness of Nivolumab for the advanced or recurrent EGFR mutation positive NSCLC. NSCLC mutation positive patients, who were treated with Nivolumab by the end of December 2016, are eligible for this study. At the end of January 2017, we evaluated 18 patients and their characteristics were as below; adenocarcinoma 17 patients/adenosqamous carcinoma 1, median age 70 (range 48-79),male 6 and female 12, 15 of them had PS 0 or 1. 13 had ex19del and 5 had L858R mutation, and all of them had received at least one regimen of EGFR-TKI. 14 of them underwent tumor biopsy to examine the presence of T790M secondary mutation. Nivolumab was administered from 3rd to 13th line chemotherapy (median 7). RR was 14.3%, DCR was 35.7% and RFS was 42 days. Grade2 adverse events were observed in two patients (rash and diarrhea in each one patient). 4 patients continue Nivolumab, and 11 proceeded to other treatment because of their disease progression. 8 of them were treated by EGFR-TKI, but none of them has experienced ILD. Our research showed low RR of Nivolumab for EGFR mutated NSCLC as seen in a previous research. And we could not reveal what causes ILD at the deadline of this abstract.