Summit Therapeutics Inc. · NASDAQ:SMMT
Summit Therapeutics — Q3 2025 Earnings Presentation
22 slides from Summit Therapeutics's earnings presentation, Oct 20, 2025
Slide 1: Summit Therapeutics ESMO Update & Q3 2025 Earnings Call
Summit Therapeutics ESMO Update & Q3 2025 Earnings Call October 20, 2025 8:00am ET
Slide 2: Forward Looking Statement
Forward Looking Statement Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s pa
Slide 3: Akeso Sponsored Trial: HARMONi-6 Phase III study in squamous NSCLC
Akeso Sponsored Trial Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6) Shun Lu1, Fang Yang2, Zhou Jiang3, Longhua Sun4, Lin Wu3, Zhengxiang Han5, Yun Fan6, Yanqiu Zhao7, Xingya
Slide 4: Study Design
Study Design Akeso Sponsored Trial A multicenter, randomized, double-blind, parallel-controlled phase III study Ivonescimab (20 mg/kg, Q3W) Ivonescimab Key Eligibility Criteria + Carboplatin (AUC 5, Q3W) (20 mg/kg, Q3W) • Pathologically confirmed up to 24 months or + Paclitaxel (175 mg/m2, Q3W) sq-N
Slide 5: Baseline Characteristics
Baseline Characteristics Akeso Sponsored Trial Ivonescimab + chemo Tislelizumab + chemo Characteristics, n(%) (N=266) (N=266) < 65 135 (50.8) 139 (52.3) Age, years ≥ 65 131 (49.2) 127 (47.7) Male 256 (96.2) 238 (89.5) Sex Female 10 (3.8) 28 (10.5) 0 42 (15.8) 42 (15.8) ECOG PS* 1 224 (84.2) 222 (83.
Slide 6: Primary endpoint: PFS by IRRC
Primary endpoint: PFS by IRRC Akeso Sponsored Trial Ivonescimab+chemo demonstrated a statistically significant improvement in PFS vs. tislelizumab+chemo with HR=0.60, representing a 4.2 months improvement in mPFS. Ivonescimab Tislelizumab + chemo + chemo (N=266) (N=266) mPFS, months 11.14 6.90 (95%
Slide 7: Subgroup Analysis of PFS by IRRC
Subgroup Analysis of PFS by IRRC Akeso Sponsored Trial • PFS benefit favored ivonescimab across all key subgroups. • Observed important baseline imbalances in the older patient subgroup (Age ≥65), such as target lesion size, brain metastases. After adjusting for these covariates, the adjusted HR for
Slide 8: PFS in different PD-L1 expression Subgroups
PFS in different PD-L1 expression Subgroups Akeso Sponsored Trial Ivonescimab showed meaningful PFS improvement over tislelizumab regardless of PD-L1 expression. PD-L1 TPS 1-49% HR 0.63 (95% CI) (0.41, 0.98) PD-L1 TPS<1% PD-L1 TPS≥1% HR 0.55 HR 0.66 (95% CI) (0.37, 0.82) (95% CI) (0.46, 0.95) PD-L1
Slide 9: ORR and DoR by IRRC
ORR and DoR by IRRC Akeso Sponsored Trial Tumor response was higher and more durable in the ivonescimab arm. ORR by IRRC DoR by IRRC Any PD-L1 PD-L1 TPS<1% PD-L1 TPS≥1% 100 p=0.008 100 100 90 90 90 80 80 80 70 70 70 ORR(%) ORR(%) ORR(%) 60 60 60 50 50 50 40 75.9 40 40 80.1 66.5 69.5 70.2 30 30 61.0
Slide 10: Safety Summary
Safety Summary Akeso Sponsored Trial Ivonescimab plus chemotherapy showed a manageable safety profile in squamous NSCLC. Most common TRAEs (incidence ≥15%) 10 Ivonescimab Tislelizumab + chemo + chemo (N=266) (N=265) TRAE 264 (99.2) 261 (98.5) Grade ≥ 3 TRAE 170 (63.9) 144 (54.3) Serious TRAE 86 (32.
Slide 11: Immune-Related and VEGF-Related AEs
Immune-Related and VEGF-Related AEs Akeso Sponsored Trial Ivonescimab exhibited similar irAEs to tislelizumab. Possibly VEGF-related AEs occurred more frequently in the ivonescimab arm, most of which were grade 1-2. Ivonescimab Tislelizumab Ivonescimab + chemo Tislelizumab + chemo Immune-related AEs
Slide 12: Conclusion
Conclusion Akeso Sponsored Trial ⚫ Ivonescimab plus chemotherapy significantly improved PFS for advanced squamous NSCLC first-line treatment compared with tislelizumab plus chemotherapy in HARMONi-6 in China. ◼ mPFS: 11.14 vs. 6.90, HR=0.60 (95%CI: 0.46, 0.78), p<0.0001 ◼ PFS benefit favored ivonesc
Slide 13: Acknowledgement
Acknowledgement Akeso Sponsored Trial ⚫ All patients participating in the study as well as their families. ⚫ All investigators and team members involved in this trial. ⚫ Akeso Biopharma Inc. who sponsored this study. https://doi.org/10.1016/S0140-6736(25)01848-3 Published Online First at https://www
Slide 14: Ivonescimab Development Plan
Ivonescimab Development Plan Phase 3 Phase 3 Planned and Ongoing Studies Conducted in China Fully Sponsored Sponsored by Summit Therapeutics and Managed by Akeso 2L+ NSCLC EGFR+: 2L+ NSCLC EGFR+: Enrollment Complete 1L NSCLC: 1L NSCLC: Enrolling 1L NSCLC: 1L NSCLC: Enrolling 2L+ NSCLC: 1L CRC: SCLC:
Slide 15: HARMONi-3 Clinical Trial Update
HARMONi-3 Clinical Trial Update Summit Sponsored Trial ⚫ Protocol Amendment: ◼ PFS and OS statistical analyses for both dual primary endpoints will be conducted separately by histology (i.e., two separate ITT analyses for squamous and non-squamous) ◼ Expected enrollment: 600 squamous, 1,000 non-squa
Slide 16: Ivonescimab + Chemo vs. Pembrolizumab + Chemo
Ivonescimab + Chemo vs. Pembrolizumab + Chemo Summit Sponsored Trial Randomized, Double-Blind, Phase 3 Study 1L Metastatic Non-Small Cell Lung Cancer (NSCLC) NCT05899608 Maintenance Ivonescimab 20 mg/kg IV + Squamous Carboplatin AUC 6 or AUC 5 IV + Ivonescimab 20 mg/kg IV Paclitaxel 200 mg/m2 IV (or
Slide 17: Ivonescimab + Chemo vs. Bevacizumab + Chemo
Ivonescimab + Chemo vs. Bevacizumab + Chemo Randomized, Double-Blind, Phase 3 Study Summit Sponsored Trial 1L Unresectable Metastatic Colorectal Cancer (CRC) Ivonescimab Ivonescimab 20 mg/kg Key Criteria 20 mg/kg + mFOLFOX6 + 5-FU/LV Q2W Q2W x 8 cycles maintenance • Metastatic CRC Endpoints • Not a
Slide 18: AK112-206: Study Design
AK112-206: Study Design (Presented at ESMO 2024) Phase 2: Akeso Sponsored Study Ivonescimab 20 mg/kg on day 1 Q2W Ivonescimab Key Eligibility Criteria + FOLFOXIRIa 20 mg/kg on day 1 Q2W + Endpoints • No prior systemic therapy for for 8 cycles 5-FU/LVb Primary recurrent or metastatic CRC n=22 • ORR (
Slide 19: AK112-206: Efficacy Data
AK112-206: Efficacy Data (Presented at ESMO 2024) Ivonescimab plus Chemotherapy in CRC; Phase 2: Akeso Sponsored Study Summary of Efficacy Best Percent Change From Baseline 20 Best Percent Change from Baseline, % Ivonescimab + Ivonescimab +FOLFOXIRI (n=22) Ivonescimab + Ivonescimab + ligufalimab + F
Slide 20: AK112-206: Safety Data
AK112-206: Safety Data (Presented at ESMO 2024) Ivonescimab plus Chemotherapy in CRC; Phase 2: Akeso Sponsored Study Summary of TRAEs Most Common TRAEs (≥10% overall) Ivonescimab + Ivonescimab + Ivonescimab + FOLFOXIRI ligufalimab + FOLFOXIRI Ivonescimab + ligufalimab + Adverse Event FOLFOXIRI FOLFO
Slide 21: Ivonescimab Development Plan
Ivonescimab Development Plan Phase 3 Phase 3 Planned and Ongoing Studies Conducted in China Fully Sponsored Sponsored by Summit Therapeutics and Managed by Akeso 2L+ NSCLC EGFR+: 2L+ NSCLC EGFR+: Enrollment Complete 1L NSCLC: 1L NSCLC: Enrolling 1L NSCLC: 1L NSCLC: Enrolling 2L+ NSCLC: 1L CRC: SCLC:
Slide 22: Additional Comments, Questions & Answers
Additional Comments, Questions & Answers