Abstract 981P
Background
Rezivertinib (BPI-7711) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both EGFR-sensitizing mutations and EGFR T790M mutation. This study aimed to evaluate the efficacy and safety of rezivertinib in treatment-naïve patients with locally advanced or metastatic/recurrent EGFR mutated non-small cell lung cancer (NSCLC).
Methods
Patients with locally advanced or metastatic/recurrent EGFR mutated NSCLC received 180mg rezivertinib once daily until unacceptable toxicity, disease progression, or withdrawal of consent. The primary endpoint was objective response rate (ORR) assessed by blinded independent central review (BICR) per RECIST1.1. The efficacy for patients with central nervous system (CNS) metastases was measured by BICR according to the Response Assessment in Neuro-Oncology Brain Metastases. Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Safety was assessed as per CTCAE 4.03.
Results
43 untreated, EGFR sensitive mutation–positive advanced NSCLC patients were enrolled. 12(27.9%) patients had CNS metastases. By the data cutoff date on Dec 23, 2021, the median duration of follow-up was 25.3 (95% CI: 25.0-26.2) months. The ORR by BICR was 83.7% (95% CI: 69.3-93.2) and DCR was 97.7% (95% CI: 87.7-99.9). The median DoR was 19.3 (95% CI: 15.8-25.0) months. The median PFS was 22.0 (95% CI: 16.8-26.3) months by investigator and 20.7 (95% CI: 13.8-24.8) months by BICR. The median OS was 25.3 (95% CI: 25.0-26.2) months. For patients with CNS metastases, the CNS-ORR was 50.0% (95% CI: 21.1-78.9) and CNS-DCR was 58.3% (95% CI: 27.7-84.8). The probability of CNS progression at 12 months was 33.3%. 40 (93.0%) patients had treatment related adverse event (TRAE) while 4 (9.3%) had grade 3 or higher. The top three TRAEs were white blood cell count decreased (44.2%), platelet count decreased (39.5%), neutrophil count decreased (30.2%).
Conclusions
Rezivertinib showed promising efficacy and favorable safety for locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation at first-line setting.
Clinical trial identification
NCT03386955(NIH) release date: December 29, 2017.
Editorial acknowledgement
Legal entity responsible for the study
Beta Pharma (Shanghai) Co., Ltd.
Funding
Beta Pharma (Shanghai) Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.