Arrivent Biopharma, Inc. · NASDAQ:AVBP
Arrivent Biopharma — European Lung Cancer Congress 2022
12 slides from Arrivent Biopharma's conference presentation, Mar 18, 2022
Slide 1: FURLONG: Furmonertinib versus gefitinib in treatment-naïve EGFR mutated NSCLC
FURLONG: Furmonertinib versus gefitinib in treatment-naïve EGFR mutated non- small cell lung cancer: a randomized, double-blind, multi-center, phase III study Yuankai Shi*1, Gongyan Chen2, Xiang Wang3, Yunpeng Liu4, Lin Wu5, Yanrong Hao6, Chunling Liu7, Shuyang Zhu8, Xiaodong Zhang9, Yuping Li10, Ji
Slide 2: Disclosure information
Disclosure information I have nothing to disclose. Presented by: Prof. Yuankai Shi
Slide 3: FURLONG Study Design
FURLONG Study Design A randomized, double-blind, multi-center phase III study conducted in 55 hospitals in mainland China Key inclusion criteria： Furmonertinib •age≥18 80mg QD Treatment until: •ECOG PS 0/1 (n=178) Randomized •Locally advanced or metastatic • Disease progression 1:1 adenocarcinoma •
Slide 4: Trial profile & baseline characteristics
Trial profile & baseline characteristics Data cut-off: Sep 15, 2021 Characteristics, data are Furmonertinib Gefitinib 750 patients assessed median (range) or n (%) （n=178） （n=179） for eligibility Age Median 59 (31-81) 60 (32-83) 392 screening failures Female 116 (65%) 111 (62%) 358 randomized to Sex
Slide 5: Primary endpoint: Progression-free survival
Primary endpoint: Progression-free survival Median PFS, months (95%CI) Furmonertinib 20.8 (17.8-23.5) Gefitinib 11.1 (9.7-12.5) HR (95%CI) 0.44 (0.34-0.58), p<0.0001* Data cut-off: Sep 15, 2021 Maturity: 62% *A two-sided p-value of 0.049 was considered to be statistically significant after an interi
Slide 6: PFS subgroup analysis
PFS subgroup analysis Furmonertinib Gefitinib n/N n/N HR (95%CI) p value <65 60/118 89/114 0.36 (0.26, 0.51) <0.0001 Age (years) ≥65 34/60 39/65 0.68 (0.43, 1.09) 0.1088 Male 33/62 56/68 0.39 (0.25, 0.61) <0.0001 Sex Female 61/116 72/111 0.49 (0.35, 0.70) <0.0001 0 16/39 23/28 0.33 (0.17, 0.63) 0.00
Slide 7: Summary of secondary endpoints
Summary of secondary endpoints Furmonertinib Gefitinib Endpoint OR / HR p-value n=178 n=179 ORR (95%CI) 89% (83-93) 84% (78-89) 1.50 (0.80-2.83) 0.2078 DCR (95%CI) 96% (91-98) 93% (89-97) 1.56 (0.61-3.98) 0.3551 DOR, median (95%CI) 19.7 months (16.8-22.1) 10.5 months (8.5-11.3) 0.39 (0.29-0.52) <0.0
Slide 8: Safety summary
Safety summary Median duration of exposure: 18.3 months with furmonertinib and 11.2 months with gefitinib Treatment-emergent adverse events (TEAEs) Treatment-related adverse events (TRAEs) Furmonertinib Gefitinib Furmonertinib Gefitinib (n=178) (n=179) (n=178) (n=179) Any AE 178 (100%) 177 (99%) Any
Slide 9: The most frequent treatment-related adverse events
The most frequent treatment-related adverse events Median duration of exposure: 18.3 months with furmonertinib and 11.2 months with gefitinib TRAEs (in ≥10% patients) AEs of interest: • interstitial lung disease (ILD) was recorded in 1 patient in each group (grade 1 in furmonertinib group, grade 2 i
Slide 10: Conclusions
Conclusions • In this randomized, double-blind, phase III FURLONG study, furmonertinib was associated with a significant longer PFS compared with gefitinib in untreated EGFR mutated NSCLC (20.8 vs 11.1 months, HR 0.44). This benefit is consistent across prespecified subgroups. • Despite a longer dur
Slide 11: Acknowledgements
Acknowledgements • We thank for all the patients and their families who participated in this study, all the 55 participating centers (listed bellow), and the study teams. This study was funded by Shanghai Allist Pharmaceutical Technology and China National Major Project for New Drug Innovation (2017
Slide 12: THANKS!
THANKS! of) elcc a Cancer Congr ess
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