Summit Therapeutics Inc. · NASDAQ:SMMT
Summit Therapeutics — Corporate Update (September 2024)
16 slides from Summit Therapeutics's corporate update, Sep 9, 2024
Slide 1: Summit Therapeutics Update Call from WCLC
Summit Therapeutics Update Call from WCLC September 9, 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 pa
Slide 3: HARMONi-2: Study Design
HARMONi-2: Study Design Akeso Sponsored Study Conducted in China A double-blind, randomized Phase III study comparing ivonescimab with pembrolizumab for patients with advanced or metastatic PD-L1-positive NSCLC (PD-L1 TPS >1%)a Patient Population Ivonescimab • Stage IIIB-IV aNSCLC 20 mg/kg Q3W (N=19
Slide 4: Baseline Characteristics
HARMONi-2 Baseline Characteristics Characteristics, n (%) Ivonescimab Pembrolizumab Total (n = 198a) (n = 200a) (n = 398a) <65 97 (49.0) 85 (42.5) 182 (45.7) Age (years) ≥65 101 (51.0) 115 (57.5) 216 (54.3) Male 164 (82.8) 169 (84.5) 333 (83.7) Sex Female 34 (17.2) 31 (15.5) 65 (16.3) 0 25 (12.6) 26
Slide 5: Primary endpoint: PFS per IRRC
HARMONi-2 Primary endpoint: PFS per IRRC Ivonescimab Pembrolizumab (n = 198) (n = 200) mPFS, mos 11.14 5.82 (95% CI) (7.33, NE) (5.03, 8.21) Stratified HR 0.51 (95% CI) (0.38, 0.69) p-value <0.0001 9-mo: 56% (47, 64) 9-mo: 40% (32, 48) Median Follow-up: 8.67 months Ivonescimab is the first compound
Slide 6: PFS Subgroup Analyses
HARMONi-2 PFS Subgroup Analyses Ivonescimab Pembrolizumab Unstratified Hazard Ratio Events/Patients Events/Patients (95% CI) Overall 72/198 112/200 0.51 (0.38, 0.69) Age <65 37/97 50/85 0.53 (0.34, 0.81) ≥65 35/101 62/115 0.52 (0.34, 0.79) Sex Male 58/164 94/169 0.53 (0.38, 0.74) Female 14/34 18/31
Slide 7: Key PFS Subgroup Analyses
HARMONi-2 Key PFS Subgroup Analyses PD-L1 Low (TPS 1-49%) PD-L1 High (TPS ≥50%) Stratified HR 0.54 Stratified HR 0.46 (95% CI) (0.37, 0.79) (95% CI) (0.28, 0.75) PD-L1 expression Squamous Non-Squamous Stratified HR 0.48 Stratified HR 0.54 (95% CI) (0.31, 0.74) (95% CI) (0.36, 0.82) NSCLC Histology I
Slide 8: ORR, DCR and DoR per IRRC
HARMONi-2 ORR, DCR and DoR per IRRC Ivonescimab Pembrolizumab (n = 198) (n = 200) ORR, % 50.0 38.5 (95% CI) (42.8, 57.2) (31.7, 45.6) DCR, % 89.9 70.5 (95% CI) (84.8, 93.7) (63.7, 76.7) Median DoR, mos NR NR (95% CI) (NE, NE) (8.28, NE) ORR and DCR were higher with ivonescimab vs. pembrolizumab. Dat
Slide 9: Safety Summary
HARMONi-2 Safety Summary TRAEs Most Common TRAEs (incidence ≥10%) Ivonescimab Pembrolizumab Safety Summary, n (%) (n = 197a) (n = 199a) TRAEs (all grades) 177 (89.8) 163 (81.9) Grade≥3 58 (29.4) 31 (15.6) Serious TRAEs 41 (20.8) 32 (16.1) Leading to discontinuation 3 (1.5) 6 (3.0) Leading to death 1
Slide 10: irAEs and Possible VEGF-Related AEs
HARMONi-2 irAEs and Possible VEGF-Related AEs irAEs Possible VEGF-Related AEs Ivonescimab Pembrolizumab Ivonescimab Pembrolizumab Safety Summary, n (%) Safety Summary, n (%) (n = 197a) (n = 199a) (n = 197a) (n = 199a) Possible VEGF-Related 94 (47.7) 42 (21.1) irAEs (all grades) 59 (29.9) 56 (28.1) A
Slide 11: Additional Promising Phase II Data for Ivonescimab (Ivo)
Additional Promising Phase II Data for Ivonescimab (Ivo) Akeso Sponsored Phase II Studies Conducted in China – Study Designs Contained in Appendix Ivo + Chemo Ivo + Chemo Ivonescimab Ivo + Chemo 1L Triple Negative Advanced Perioperative Resectable NSCLC CPS <10% CPS >10% (n=11) (n=49) Breast Cancer
Slide 12: Ivonescimab Global Clinical Trials
Ivonescimab Global Clinical Trials Indication Study Treatment Population Regimen Phase Status 2L EGFRm+ + Chemo vs. chemo III Ongoing Ivonescimab NSCLC 1L Squamous + Chemo vs. pembrolizumab (PD-1) + chemo III Ongoing More Than 25 1L PD-L1 TPS >50% Monotherapy vs. pembrolizumab (PD-1) III Planned Cli
Slide 13: Q&A
Summit therapeutics ret i Q&A
Slide 14: Summit Therapeutics Update Call from WCLC
Summit Therapeutics Update Call from WCLC September 9, 2024
Slide 15: Appendix
Summit therapeutics ret j Appendix + -4ede
Slide 16: Study Designs for Additional Phase II for Ivonescimab (Ivo)
Study Designs for Additional Phase II for Ivonescimab (Ivo) Akeso Sponsored Phase II Studies Conducted in China • 1L MSS Metastatic Colorectal Cancer (mCRC): • Perioperative Resectable NSCLC: • This was an open-label, multicenter, phase II randomized study. • This was an open-label, multi-center pha
Summit Therapeutics — Corporate Update (September 2024) on 6ix