Shanghai Allist Pharmaceuticals Co. Ltd. Class A · SSE:688578
Shanghai Allist Pharmaceuticals Co. Ltd. Class A — Technical Presentation (September 2021)
14 slides from Shanghai Allist Pharmaceuticals Co. Ltd. Class A's technical presentation, September 2021
Slide 1: CNS efficacy of furmonertinib (AST2818) in T790M-positive advanced NSCLC
P76.65 - CNS efficacy of furmonertinib (AST2818) in patients with T790M-positive advanced NSCLC: data from a phase I-II dose-expansion study Yuankai Shi1, Xingsheng Hu1, Wangjun Liao2, Shucai Zhang3, Ziping Wang4, Nong Yang5, Lin Wu5, Jianying Zhou6, Kejing Ying7, Zhiyong Ma8, Jifeng Feng9, Li Liu10
Slide 2: Disclosures
DISCLOSURES Jiang Yong and Nan Ge are employees and shareholders of Shanghai Allist Pharmaceuticals Co., Ltd. . All other authors declare no competing interests.
Slide 3: Background
Background • Central nervous system (CNS) metastases are common in patients with epidermal growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) with >40% patients reported to have a negative impact on survival and quality of life (QoL).1-3 • Furmonertinib (AST2818, former name: a
Slide 4: Objective
Objective • To carry out subgroup analysis from phase I-II dose-expansion study (NCT03127449) where the CNS efficacy of different furmonertinib doses was evaluated in patients with EGFR T790M-positive advanced NSCLC. Abbreviations: CNS, central nervous system; EGFR, epidermal growth factor receptor;
Slide 5: Method: Study design
Method Study design Eligible patients Phase I-II dose-expansion Furmonertinib，orally，once daily • Patients aged ≥18 years old • Histological or cytological confirmed locally advanced Dose N=116 or metastatic NSCLC and not suitable for operation or radiotherapy 40mg 6 • Measurable disease progression
Slide 6: Methods
Methods Method This subgroup analysis was conducted in patients with CNS metastases confirmed by blinded independent central review (BICR). Outcomes Analysis sets Primary outcome： ➢ CNS full analysis set (cFAS): Patients with ≥1 • CNS objective response rate (ORR) measurable and/or non-measurable CN
Slide 7: Results: Patient disposition data
Patient disposition data Results Patients screened for eligibility • Out of 192 patients screened,116 patients (n=192) • Patients not eligible (n=76) • T790M negative (n=48) were enrolled and received furmonertinib • Do not meet other inclusion criteria (n=5) at variable doses (40mg, 80mg, 160mg, or
Slide 8: Baseline characteristics
Patients Baseline characteristics Baseline demographics and disease characteristics of cFAS 40mg 80mg 160mg 240mg Total Characteristic n=3 n=12 n=23 n=7 N=45 Age: median (range), years 47 (44-55) 57 (41-72) 53 (39-67) 55 (37-74) 54 (37-74) Gender, n (%) Male / female 1(33.3)/ 2(66.7) 4(33.3)/ 8(66.7
Slide 9: Efficacy: CNS tumor response
Efficacy Efficacy CNS tumor response to furmonertinib confirmed by BICR Response 40mg 80mg 160mg 240mg Total cEFR, n 1 5 13 4 23 • At data cutoff (29 January 2020), CNS Objective response, n confirmed CNS ORR was 65.2% CR 0 0 1 0 1 (15/23; 95% CI, 42.7% to 83.6%) PR 0 3 10 1 14 SD 0 1 2 3 6 while CN
Slide 10: Efficacy: Best percentage change in CNS lesion size
Efficacy Efficacy Best percentage change from baseline in measurable CNS lesion size by BICR Only one patient from 40mg group was PD confirmed by BICR. Only patients with at least one post baseline RECIST target lesion assessment scan were presented. Best percentage change in target lesion size is t
Slide 11: Efficacy: CNS progression free survival
Efficacy Efficacy CNS progression free survival of cFAS • Median follow-up time: 9.6 months (range 0.1- 26.1 months) • Median CNS PFS not reached (95%CI 8.3 months to not reached, maturity 35.6%) Dose PFS (95%CI), months 40mg 2.8 (1.4, 8.3) 80mg 9.7 (8.3, NR) 160mg 19.3 (5.5, NR) 240mg Not reached (
Slide 12: Safety
Safety • Overall safety profile of this phase I-II dose-expansion study has been reported with no new signals1. • No interstitial lung disease (ILD) was observed. References:1. Shi Y, et al. JTO. 2020; 15:1015-1026.
Slide 13: Conclusion
Conclusion • Furmonertinib (AST2818) demonstrated clinically meaningful efficacy against CNS metastases. • Furmonertinib dose at 160 mg provided relevant benefit with a high CNS ORR and PFS. • However, data for mature CNS PFS are not available and thus the observed CNS treatment may be overestimated
Slide 14: Acknowledgements
Acknowledgements • This study was sponsored by Shanghai Allist Pharmaceuticals Co., Ltd. China and also supported by the China National Major Project for New Drug Innovation (2017ZX09304015, 2018ZX09301014009, and 2019ZX09201-002) and Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Me
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