Slide 1: Summit Therapeutics Update Call from ASCO
Summit Therapeutics Update Call from ASCO June 3, 2024
Slide 2: Forward Looking Statement
Forward Looking Statement Any statements in this presentation 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 par
Slide 3: Ivonescimab Phase III Trials
Ivonescimab Phase III Trials A 2L+ NSQ NSCLC EGFRm+ after a 3rd Gen TKI 2L+ NSQ NSCLC EGFRm+ after a TKI Ivonescimab + chemo Ivonescimab + chemo vs. placebo + chemo vs. placebo + chemo 2 3 1L SQ + NSQ NSCLC PD-L1 TPS ≥ 1% 1L NSCLC Squamous Ivonescimab Ivonescimab + chemo vs. pembrolizumab vs. pembro
Slide 4: HARMONi-A Study Design
4 HARMONi-A Study Design Key Eligibility Criteria Ivonescimab Ivonescimab 20mg/kg 20mg/kg Q3W • nsq-NSCLC (Stage IIIB/C ineligible for surgery + Treatment until: + or local therapy and IV ) Pemetrexed 500 mg/m2 Pemetrexed 500 Carboplatin AUC5 mg/m2 Q3W • Intolerable toxicity • EGFR sensitive mutatio
Slide 5: HARMONi-A: Study Met Primary Endpoint of PFS per IRRC
5 HARMONi-A: Study Met Primary Endpoint of PFS per IRRC HR and P-value were stratified by previous 3rd Gen EGFR-TKI ues (yes vs. no) and presence of brain metastases (yes vs. no), and were calculated with stratified Cox model and log rank test. The two-sided P-value boundary is 0.024 as calculated u
Slide 6: HARMONi-A: PFS by Presence of Brain Metastases
6 HARMONi-A: PFS by Presence of Brain Metastases PFS Kaplan Meier Curve Evaluated by IRRC PFS Kaplan Meier Curve Evaluated by IRRC without Brain Metastasis with Brain Metastasis Probability of Progression-free survival (%) Probability of Progression-free survival (%) HR HR (95% CI): 0.48 (0.34, 0.69
Slide 7: HARMONi-A: Overall Survival (at 30% of data maturity)
7 HARMONi-A: Overall Survival (at 30% of data maturity) HR: 0.72 (0.48, 1.09) after 96 events, 30% data maturity Two OS analyses were performed per request by Chinese Regulatory Authority (1st analysis at 30% and 2nd at 52% of data maturity) Data cutoff date: June 25, 2023 (median follow-up of 10.2
Slide 8: HARMONi-A: Overall Survival (at 52% of Data Maturity)
HARMONi-A: Overall Survival (at 52% of Data Maturity) 8 HR: 0.80 (0.59, 1.08) after 52% of data maturity OS is consistent for both analysis Data cutoff date: December 2023 (median follow-up of 17.6 months) HR, hazard ratio; CI, confidence interval. 8 Presented by Dr. Li Zhang, MD / ASCO 2024 Ivonesc
Slide 9: HARMONi-A: Safety Summary
HARMONi-A: Safety Summary 9 Ivonescimab + Placebo + TRAE, n(%) Chemotherapy Chemotherapy (N=161） (N=161) Any grade 158 (98.1) 153 (95.0) Grade≥3 87 (54.0) 69 (42.9) Serious* 46 (28.6) 26 (16.1) Led to discontinuation of ivonescimab/placebo 9 (5.6) 4 (2.5) Led to death 0 (0.0) 0 (0.0) Grade≥3 immune-
Slide 10: HARMONi-A: Most Common Adverse Events (incidence ≥ 15%)
10 HARMONi-A: Most Common Adverse Events (incidence ≥ 15%) WBC count decreased Neutrophil count decreased Platelet count decreased 10 Presented by Dr. Li Zhang, MD / ASCO 2024 Ivonescimab is an investigational therapy not approved by any regulatory authority other than Summit Confidential & Propriet
Slide 11: HARMONi-A: Immune-related Adverse Events (irAE)
HARMONi-A: Immune-related Adverse Events (irAE) 11 Categories Ivonescimab + Chemotherapy (N=161） Placebo + Chemotherapy (N=161) Preferred Term, n(%) Any grade Grade ≥ 3 Any grade Grade ≥ 3 irAE 39 (24.2) 10 (6.2) 10 (6.2) 4 (2.5) Hypothyroidism 17 (10.6) 1 (0.6) 0 0 Hyperthyroidism 9 (5.6) 0 0 0 Ras
Slide 12: HARMONi-A: Adverse Events of Special Interest (AESI)
12 HARMONi-A: Adverse Events of Special Interest (AESI) Categories Ivonescimab + Chemotherapy (N=161） Placebo + Chemotherapy (N=161) Preferred Term, n(%) Any grade Grade ≥ 3 Any grade Grade ≥ 3 AESI 48 (29.8) 5 (3.1) 25 (15.5) 4 (2.5) Proteinuria 28 (17.4) 1 (0.6) 13 (8.1) 0 Haemorrhage 11 (6.8) 0 8
Slide 13: Ivonescimab Global Oncology Clinical Trials
Ivonescimab Global Oncology Clinical Trials Trial Indication Histology/Population Regimen Phase III EGFRm+ 2L+ Combo ivonescimab + chemo NSCLC Advanced or Metastatic vs. placebo + chemo NSCLC Squamous 1L Metastatic Combo ivonescimab + chemo vs. pembro + chemo 1,600+ Patients Treated with Indication
Slide 14: Ivonescimab is an investigational therapy not approved by any regulatory authority other than China’s
14 14 Ivonescimab is an investigational therapy not approved by any regulatory authority other than Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation China’s National Medical Products Administration (NMPA) Summit Update – June 2024 HARMONi-2 are sponsored by Akes
Slide 15: Q&A
Summit therapeutics Q 7 Q&A - 4044
Slide 16: Summit Therapeutics ASCO Update call
Summit Therapeutics ASCO Update call June 3, 2024