Carsgen Therapeutics Holdings Ltd. · HKEX:2171
Carsgen Therapeutics — 2025 ASCO Annual Meeting
23 slides from Carsgen Therapeutics's conference presentation, June 2025
Slide 1: Claudin18.2-specific CAR T cells (Satri-cel) versus TPC in G/GEJC: Primary Results
Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary Results from a randomized, open-label, phase II trial (CT041-ST-01) Changsong Qi1, Chang Liu1, Zhi Peng1, Yanqiao Zh
Slide 2: Key Takeaway Points/Conclusions
2 Key Takeaway Points/Conclusions • Satricabtagene autoleucel (satri-cel)/CT041 demonstrated significant progression-free survival (PFS) improvement and a clinically meaningful overall survival (OS) benefit in patients with previously treated, advanced G/GEJC. ✓ Globally, this is the first ever rand
Slide 3: Background
3 Background • Claudin18.2 (CLDN18.2) is overexpressed in various gastrointestinal tumours, particularly in G/GEJC, and it has emerged as a promising therapeutic target in G/GEJC1. • Satri-cel/CT041, an autologous CLDN18.2-specific CAR T therapy, had showed encouraging efficacy in previously treated
Slide 4: Trial Design and Procedure schema
4 Trial Design and Procedure schema An open-label, multicenter, randomized controlled trial conducted in China. n=104 Study population Bridging Satri-cel Disease progression or Apheresis Lymphodepletion therapy (250 ×106 cells) intolerable toxicity, etc. • 18-75 years of age • Advanced G/GEJC confir
Slide 5: Statistical Considerations
5 Statistical Considerations • For primary endpoint PFS, a HR of 0.55 (45% risk reduction with satri-cel vs TPC) was hypothesized and median PFS in TPC was 3 months. The event goal for PFS to achieve 84.7% power at 1-sided α of 0.025 was 114. The sample size was 150 based on an estimate of 114 PFS e
Slide 6: Patient Disposition
6 Patient Disposition 266 patients were screened 110 excluded ITT population 156 randomly assigned (2:1) 104 assigned to satri-cel group 52 assigned to TPC group 48 received apheresis* 104 received apheresis 101 received bridging therapy 4 did not receive TPC 16 did not receive satri-cel 2 withdrawa
Slide 7: Baseline Characteristics
7 Baseline Characteristics Satri-cel group TPC group Satri-cel group TPC group Characteristics Characteristics (n=104) (n=52) (n=104) (n=52) Age, median (IQR), years 53.5 (45.0, 60.0) 50.5 (43.0, 58.0) CLDN18.2 expression, n (%)† Sex, n (%) Medium expression 24 (23.1) 10 (19.2) Male 56 (53.8) 31 (59
Slide 8: Primary Endpoint: PFS (ITT) assessed by IRC
Primary Endpoint: PFS (ITT) assessed by IRCa Satri-cel demonstrated statistically significant PFS improvement Satri-cel TPC Events/patients 80/104 37/52 Median PFS, months 3.25 1.77 (95% CI) （2.86-4.53） (1.61-2.04) HR (95% CI) 0.366 (0.241-0.557) P value (one-sided) <0.0001 6-month PFS rate: 24% vs
Slide 9: Key Secondary Endpoint: OS (ITT)
9 Key Secondary Endpoint: OS (ITT) Satri-cel demonstrated clinically meaningful OS benefit Satri-cel TPC Events/patients 70/104 35/52 Median OS, months 7.92 5.49 (95% CI) （5.78-10.02） (3.94-6.93) HR (95% CI) 0.693 (0.457-1.051) P value (one-sided) 0.0416 12-month OS rate: 35% vs 26% 18-month OS rate
Slide 10: PFS and OS Subgroup Analysis (ITT)
PFS and OS Subgroup Analysis (ITT) PFS and OS benefit of Satri-cel was observed across the prespecified subgroups Subgroup analysis of PFS Subgroup analysis of OS PRESENTED BY: Changsong Qi, MD
Slide 11: PFS and OS Supplementary Analysis (mITT)
PFS and OS Supplementary Analysis (mITT) In treated population, PFS per IRC and OS were obviously longer in Satri-cel group vs TPC group PFS assessed by IRCa OS in mITT population Satri-cel TPC Satri-cel TPC Events/patients 68/88 35/48 Events/patients 58/88 32/48 Median PFS, months 4.37 1.84 Median
Slide 12: Secondary Endpoints: PFS assessed by Investigator
12 Secondary Endpoints: PFS assessed by Investigator PFS was obviously longer in Satri-cel group vs TPC group both in ITT and mITT set In ITT populationa In mITT populationa Satri-cel TPC Satri-cel TPC Events/patients 83/104 40/52 Events/patients 71/88 38/48 Median PFS, months 4.53 1.71 Median PFS,
Slide 13: Adjusting for treatment switching: OS analyzed by RPSFT model
Adjusting for treatment switching: OS analyzed by RPSFTa model The estimated mOS was 1.81-2.06 fold longer with satri-cel vs TPC, providing a 53% and 63% reduction in risk of mortality in the ITT and mITT populations, respectively. OS (ITT) analyzed by RPSFT model OS (mITT) analyzed by RPSFT model S
Slide 14: Tumor Response assessed by IRC
14 Tumor Response assessed by IRCa ORR and DCR were obviously improved in patients treated with satri-cel Changes in target lesions Satri-cel group TPC group (n=76b) (n=45b) Best overall response CR, n (%) 0 0 PR, n (%) 23 (30) 2 (4) SD, n (%) 30 (40) 9 (20) PD, n (%) 22 (29) 24 (53) NE, n (%) 1 (1)
Slide 15: Tumor Response assessed by Investigator
15 Tumor Response assessed by Investigatora ORR and DCR were obviously improved in patients treated with satri-cel Satri-cel group TPC group Changes in target lesions (n=88) (n=48) Best overall response CR, n (%) 0 0 PR, n (%) 36 (41) 2 (4) SD, n (%) 35 (40) 11 (23) PD, n (%) 16 (18) 25 (52) NE, n (
Slide 16: Safety: Adverse events in the safety set
16 Safety: Adverse events in the safety set Satri-cel group (n=88) TPC group (n=48) Safety, n (%) All grade Grade ≥3 All grade Grade ≥3 All treatment-emergent adverse events 88 (100%) 87 (98.9%) 44 (91.7%) 30 (62.5%) (TEAEs) TEAEs related to treatment (TRAEs) 88 (100%) 87 (98.9%) 44 (91.7%) 27 (56.3
Slide 17: Safety: TRAEs
17 Safety: TRAEs# #Including All TRAEs with an incidence of ≥ 20% or Grade ≥ 3 with incidence of ≥ 5%. *TRAEs: treatment-emergent adverse events (TEAEs) related to treatment. Treatment was defined as bridging therapy, lymphodepletion and Satri-cel infusion in Satri-cel group and treatment of physici
Slide 18: Adhoc analysis: OS
18 Adhoc analysis: OS Updated analysis with 5 months additional follow-up after primary analysis OS improvement are more obvious in the satri-cel group with longer follow-up OS (ITT) OS (mITT) Satri-cel TPC Satri-cel TPC Events/patients 81/104 43/52 Events/patients 69/88 40/48 Median OS, months 8.15
Slide 19: Limitations
19 Limitations • The sample size in this study was powered for primary endpoint and therefore, may not be adequate to yield definitive conclusions from the subgroup analyses. • There were 16 patients whose CAR T-cells could not be infused after apheresis in the satri-cel group mostly due to rapid tu
Slide 20: Conclusions / Key Takeaways
20 Conclusions / Key Takeaways ⚫ Satri-cel/CT041 demonstrated statistically significant PFS improvement and clinically meaningful overall survival benefit in G/GEJC patients compared to standard of care. • In ITT population, mPFS assessed by IRC: HR 0.366 (95% CI: 0.241, 0.557; p<0.0001); mOS: HR 0.
Slide 21: Full Publication- The Lancet
21 Full Publication- The Lancet https://doi.org/10.1016/S0140-6736(25)00860-8 Published Online First at https://www.thelancet.com/journals/lancet/onlinefirst PRESENTED BY: Changsong Qi, MD,PhD
Slide 22: Acknowledgements
22 Acknowledgements • We extend our sincere gratitude to all patients and their Patients and their families families for their participation in this study Investigators • We gratefully acknowledge all study investigators, steering Steering committee committee members, and site staff for their dedica
Slide 23: Lay Summary
23 Lay Summary • Globally, this is the first ever study of CAR T-cell therapy compared with the current available standard of care, it aims to show whether CAR T-therapy can achieve a better efficacy in late-stage gastric cancer. • In this study, late-stage gastric cancer patients with a tumor bioma
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