Apollomics Inc. · NASDAQ:APLM
Apollomics — Technical Presentation
16 slides from Apollomics's technical presentation
Slide 1: Efficacy and safety of vebreltinib in IDH mutant high-grade glioma (FUGEN)
Efficacy and safety of the vebreltinib in previously treated, IDH mutant high-grade glioma patients with PTPRZ1-MET FUsion GENe (FUGEN): a randomized, multicentre, open-label, phase II/III trial Tao Jiang1, Zhaoshi Bao2, Yake Xue3, Yanhui Liu4, Shouwei Li5, Liang Wang6, Yan Qu6, Yonggao Mou7, Rutong
Slide 2: FUGEN trial Take-home Messages
2 FUGEN trial_Take-home Messages • A randomized, multicentre, open-label, phase II/III trial; • A total of 84 patients were enrolled and randomized 1:1 to Vebreltinib or control (temozolomide or cisplatin with etoposide) • The median OS in the vebreltinib and control group was 6.31 months (95% CI, 4
Slide 3: Background: PTPRZ1-MET Fusion Gene Has Independent Prognostic Value
3 Background_PTPRZ1-MET（ZM） Fusion Gene has Independent Prognostic Value for Glioma Patients • The ZM fusion gene was discovered in 15% of patients with IDHmut astrocytoma WHO grade 4; • Survival analyses demonstrated that IDHmut astrocytoma WHO grade 4 patients with ZM fusion had poorer OS than tho
Slide 4: Background: Vebreltinib is a BBB-permeable, Efficient and Safe MET Inhibitor
4 Background_Vebreltinib is a BBB-permeable, Efficient and Safe MET Inhibitor • Expression of ZM fusions resulted in hyper-activation of MET and STAT3 signaling; • Phase I to identify RP2D: 300mg BID; • Vebreltinib was well tolerated and demonstrated preliminary anti-tumor activity in IDH mutant hig
Slide 5: FUGEN trial: Phase II/III Study Design
5 FUGEN trial：Phase II/III Study Design Key eligibility criteria Vebreltinib 300mg BID, 28-day/cycle • Age: 18-65 Primary endpoint： • Histologically confirmed • Overall survival astrocytoma IDHmut WHO N=84 Temozolomide dose-dense regimen: secondary endpoint： grade 4 or GBM with LGG 100-150 mg/m^2/d
Slide 6: FUGEN trial: Patient Disposition
6 FUGEN trial：Patient Disposition • From July 2018 to September 2022 n=98 patients screened Analysis Vebreltinib Control ALL n=14 ineligible Populations group group n=84 patients randomized ITT 43 41 84 FAS 42 39 81 n=84 patients treated SAS 43 41 84 n=43 vebreltinib group n=41 Control group n=1 Cis
Slide 7: Results: Baseline Demographics and Disease Characteristics
7 Results_Baseline Demographics and Disease Characteristics Vebreltinib Control Vebreltinib Control group group All group group All (N=42) (N=39) (N=81) (N=42) (N=39) (N=81) Age (years) 45.77 (35.011) 50.32 47.90 Mean (SD) (31.300) (33.192) Mean (SD) 41.6 (9.47) 41.1 (9.58) 41.4 (9.47) 35.45 51.09 4
Slide 8: Results: Primary Endpoint: Overall Survival (FAS)
8 Results_Primary Endpoint: Overall Survival (FAS) • As of April 1st, 2023, the average follow-up was 9.9 months in the vebreltinib group and 6.8 months in the control group; • Based on Full Analysis Set (FAS): Vebreltinib treatment group extended mOS from 3.38 months to 6.31 months, with HR value o
Slide 9: Results: Primary Endpoint: Overall Survival (ITT)
9 Results_Primary Endpoint: Overall Survival (ITT) • As of April 1st, 2023, the average follow-up was 9.9 months in the vebreltinib group and 6.8 months in the control group • Vebreltinib demonstrated the capacity to extend the median survival period from 3.68 months to 6.31 months, compared with th
Slide 10: Results: Secondary Endpoint PFS and ORR (FAS)
10 Results_Secondary Endpoint PFS and ORR (FAS) ORR Vebreltinib group Control group PFS (N=42) (N=39) The objective response rate, n (%) 4 ( 9.5) 1 ( 2.6) 95% CI (2.66, 22.62) (0.06, 13.48) Complete Response, n (%) 1 ( 2.4) 1 ( 2.6) Partial Response, n (%) 3 ( 7.1) 0 Stable Disease, n (%) 20 (47.6)
Slide 11: Results: Reduction in Risk of Mortality Across Subgroups
11 Results_Notable Reduction in the Risk of Mortality Observed across Various Subgroups in Vebreltinib Group Control group: Temozolomide group or Cisplatin combined with Etoposide group * Concomitant antitumor therapy is defined as of those were received non-investigational antitumor therapy during
Slide 12: Results: Subgroup Analysis of Tumor Size at Baseline ≤ 3cm
12 Results_Subgroup Analysis of the Impact of Tumor Size at Baseline ≤ 3cm OS_ Tumor Size at Baseline ≤ 3cm OS_ Tumor Size at Baseline ＞ 3cm PRESENTED BY: Professor Zhaoshi Bao and Academician Tao Jiang
Slide 13: Results: Safety summary
13 Results_Safety summary Vebreltinib group Control group（N=41） Total Temozolomide（N=40） Cisplatin combined with Control group total （N=43） etoposide（N=1） (N=41) （N=84） TEAEs*, n(%) 43 ( 100) 36 (90.0) 1 ( 100) 37 (90.2) 80 (95.2) Grades ≥3 TEAE 27 (62.8) 23 (57.5) 1 ( 100) 24 (58.5) 51 (60.7) SAE 2
Slide 14: Results: TRAEs and SAE (Safety Analysis)
14 Results_TRAEs and SAE (Safety Analysis) Vebreltinib group (N=43a) Control group (N=41a) Event Event Grade 3 Grade 4 Grade 5 Grade ≥3 Any Grade Grade 3 Grade 4 Grade 5 Grade ≥3 Any Grade n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) Any TRAEs b 2 ( 4.7) 1 ( 2.3) 0 3 ( 7.0) 26 (60.5)
Slide 15: Summary
15 Summary • The FUGEN study resulted in statistical and clinical improvement in OS, and PFS in patients diagnosed with IDH mutant high-grade glioma bearing ZM fusion，when compared to the control group (Temozolomide or Cisplatin combined with Etoposide); • These findings highlight the substantial an
Slide 16: Acknowledgments
16 Acknowledgments • The authors would like to thank the following: • Patients and their families for their participation; • Investigators and sites; • This study was sponsored by Beijing Pearl Biotechnology Co., Ltd. and Avistone Biotechnology Limited. PRESENTED BY: Professor Zhaoshi Bao and Academ