Summit Therapeutics Inc. · NASDAQ:SMMT
Summit Therapeutics — 2024 World Conference on Lung Cancer Presidential Symposium
14 slides from Summit Therapeutics's conference presentation, Sep 9, 2024
Slide 1: Phase 3 Study of Ivonescimab vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: HARMONi-2
Phase 3 Study of Ivonescimab (AK112) vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: HARMONi-2 C. Zhou1,2, J. Chen3, L. Wu3, L. Wang1, A. Xiong1, B. Liu4, J. Yao5, H. Zhong6, J. Li7, Y. Cheng8, Y. Sun9, H. Ge10, Q. Shi11, M. Zhou12, Z. Han13, J. Wang14, Q. Bu15, Y. Zhao1
Slide 2: Disclosures
Caicun Zhou | HARMONi-2 • Honoraria as a speaker: Lilly China, Sanofi, BI, Roche, MSD, Qilu, Hengrui, Innovent Biologics, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc, Amoy Diagnositics. • Advisor: Innovent Biologics, Hengrui, Qilu, TopAlliance Biosciences Inc. Disclosures Ivonescimab is an inv
Slide 3: Background
• Anti-PD-1/L1 monotherapy or in combination with chemotherapy has been the standard of care for the first- line treatment of PD-L1 positive aNSCLC without driver gene alterations. • Monotherapy with an immune checkpoint inhibitor provides limited clinical benefit for PD-L1 positive aNSCLC1-2. • Ivo
Slide 4: HARMONi-2 (AK112-303) Study Design
A randomized, double-blind, phase 3 studya Stratification • Clinical stage (IIIB/C vs. IV) • Histology (SQ vs. non-SQ) • PD-L1 TPS (≥50% vs. 1-49%) HARMONi-2 (AK112-303) Study Design Patient Population • Stage IIIB-IV aNSCLC • No prior systemic therapy • No EGFR mutations or ALK rearrangements • ECO
Slide 5: Baseline Characteristics
Baseline Characteristics Characteristics, n (%) Ivonescimab (n = 198a) Pembrolizumab (n = 200a) Total (n = 398a) Age (years) <65 97 (49.0) 85 (42.5) 182 (45.7) ≥65 101 (51.0) 115 (57.5) 216 (54.3) Sex Male 164 (82.8) 169 (84.5) 333 (83.7) Female 34 (17.2) 31 (15.5) 65 (16.3) ECOG PS 0 25 (12.6) 26 (
Slide 6: Primary endpoint: PFS per IRRC
9-mo: 40% (32, 48) Median Follow-up: 8.67 months 9-mo: 56% (47, 64) Primary endpoint: PFS per IRRC Abbreviations: mPFS, median progression-free survival; IRRC, independent radiology review committee; mo, month; NE, not estimable; HR: hazard ratio; CI, confidence interval. Caicun Zhou | HARMONi-2 Ivo
Slide 7: PFS Subgroup Analyses
0.06 0.1 1 10 Ivonescimab Better Pembrolizumab Better PFS Subgroup Analyses Ivonescimab Pembrolizumab Events/Patients Events/Patients Overall 72/198 112/200 Age <65 37/97 50/85 ≥65 35/101 62/115 Sex Male 58/164 94/169 Female 14/34 18/31 ECOG PS 0 4/25 19/26 1 68/173 93/174 Smoking Status Never 13/39
Slide 8: Key PFS Subgroup Analyses
Key PFS Subgroup Analyses Caicun Zhou | HARMONi-2 Abbreviations: PFS, progression-free survival; PD-L1, programmed death ligand 1; TPS, tumor proportion score; HR: hazard ratio; CI, confidence interval; NSCLC, non-small cell lung cancer. PD-L1 Low (TPS 1-49%) Ivonescimab showed meaningful improvemen
Slide 9: ORR, DCR and DoR per IRRC
Caicun Zhou | HARMONi-2 Data cut off: January 29, 2024. Abbreviations: ORR, overall response rate; DCR, disease control rate; DoR, duration of response; IRRC, independent radiology review committee; CI, confidence interval; mo, month; NR, not reached; NE, not estimable. Ivonescimab (n = 198) Pembrol
Slide 10: TRAEs Safety Summary
b a Patients who received ≥1 dose of study treatment. b The incidence of ≥grade 3 Hypertension was 0.5%. Abbreviations: AEs, adverse events; TRAEs, treatment-related adverse events; SQ, squamous cell carcinoma. TRAEs Safety Summary Caicun Zhou | HARMONi-2 Ivonescimab showed a manageable safety profi
Slide 11: Immune-Related and Possible VEGF-Related AEs
Caicun Zhou | HARMONi-2 Immune-Related and Possible VEGF-Related AEs • All VEGF-related AEs were grades 1-3 in both arms. • Grade 3 haemorrhage was observed in two patients with non-SQ and was not reported in SQ patients in the ivonescimab arm. irAEs Safety Summary, n (%) Ivonescimab (n = 197a) Pemb
Slide 12: Time to deterioration of global health status – EORTC QLQ-C30
a Deterioration of global health status/quality of life (QoL) refers to a decrease of 10 points or greater from the baseline in standardized score. Time to deterioration is defined as the time from the date of randomization to the date of first occurrence of deterioration. b Patients who completed E
Slide 13: Conclusions
Conclusions Caicun Zhou | HARMONi-2 • First-line ivonescimab significantly improve IRRC-assessed PFS in patients with aNSCLC and PD-L1 TPS ≥1%, compared with pembrolizumab (median PFS (mos), 11.14 vs. 5.82; HR, 0.51; p<0.0001). • PFS benefit with ivonescimab were consistent across major clinical sub
Slide 14: Acknowledgments
Acknowledgments Caicun Zhou | HARMONi-2 • We sincerely thank all the participants and their families. • Thank you to all of the investigators and study site personnel from 55 sites. • Thanks to all personnel of Akeso Biopharma, Inc. who supported the study. 14 2024 World Conference on Lung Cancer Pr
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