Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study

Table 2 The overall and CNS efficacy of rezivertinib in FAS

Efficacy	BICR-assessed (n = 43)	Investigator-assessed (n = 43)	Brain Metastases at baseline (n = 12)
Response, n (%)
CR	0	0	2 (16.7)
PR	36 (83.7)	30 (69.8)	4 (33.3)
SD	6 (14.0)	11 (25.6)	1 (8.3)
Non-CR/Non-PD	NA	NA	5 (41.7)
PD	1 (2.3)	2 (4.7)	0
ORR, n (%)	36 (83.7)	30 (69.8)	6 (50.0) ^a
95% CI	69.3 to 93.2	53.8 to 83.0	21.1 to 78.9
DCR, n (%)	42 (97.7)	41 (95.3)	7 (58.3) ^b
95% CI	87.7 - 99.9	84.2 - 99.4	27.7 - 84.8
DoR, months	19.3	19.3	NA
Median (95% CI)	15.8 - 25.0	8.3 - 25.0	NA
PFS, months	20.7	22.0	NA
Median (95% CI)	13.8 - 24.8	16.8 - 26.3	NA

Abbreviations: ORR Objective response rate, DCR Disease control rate, DoR Duration of response, PFS Progression-free survival, FAS Full analysis set, CNS Central nervous system, RANO-BM Response Assessment in Neuro-Oncology Brain Metastases, CR Complete response, PR Partial response, SD Stable disease, PD Progressive disease, NA Not applicable
^aCNS-ORR was defined as the proportion of confirmed CR or PR in brain metastatic lesions evaluated by BICR according to the RANO-BM criteria
^bCNS-DCR was defined as the proportion of confirmed CR, PR, or SD in brain metastatic lesions evaluated by BICR according to the RANO-BM criteria

ISSN: 1741-7015