Cogent Biosciences, Inc. · NASDAQ:COGT
Cogent Biosciences — CTOS Annual Meeting 2023
11 slides from Cogent Biosciences's conference presentation, Nov 1, 2023
Slide 1: Peak Study: A Phase 3 Study of Bezuclastinib and Sunitinib Versus Sunitinib in GIST
Peak Study: A Phase 3, Randomized, Open-Label, Multicenter Clinical Study of Bezuclastinib (CGT9486) and Sunitinib Combination Versus Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST) 1Neeta Somaiah, MD, 2Michael C. Heinrich, MD, FACP, 3Jonathan C. Trent, MD, PhD, 4Breelyn Wilky, MD,
Slide 2: Bezuclastinib + Sunitinib Combination Targets the Full Spectrum of Primary and Secondary Mutations
• The worldwide standard for first-line therapy of advanced KIT-mutant GIST is treatment with Bezuclastinib + Sunitinib Combination Targets the imatinib, which targets primary KIT mutations in Full Spectrum of Primary and Secondary Mutations exons 9 and 11. Primary Secondary Broad Coverage of Spectr
Slide 3: Activity Against Closely Related Kinases
Activity Against Closely Related Kinases Cell IC50 (nM)* Compound PDGFRα PDGFRß CSF1R FLT3 VEGFR2 Bezuclastinib >10,000 >10,000 >10,000 >1000 >1000 Imatinib 75 247 1027 >1000 >1000 Sunitinib 23 14 313 1 4 Regorafenib 138 1180 473 237 101 Avapritinib 53 10 249 305 >1000 Ripretinib 20 34 312 534 110
Slide 4: Phase 1/2 trial: bezuclastinib + sunitinib well tolerated with clinical activity
• In a Phase 1/2 trial, combination of bezuclastinib + sunitinib was well tolerated and demonstrated clinical activity in pts with relapsed/refractory GIST1 • Median PFS for the combination was 12.1 months • In a subset of 6 patients with known exon 17/18 secondary mutations and without exon 13/14 m
Slide 5: Trial in Progress
Trial in Progress PART 2 RANDOMIZED STUDY∂ N~388 bezuclastinib 600 mg QD + sunitinib 37.5 mg QD Prior PART 1a OPTIMIZED Imatinib FORMULATION Only LEAD-IN R 1:1 N=19 sunitinib 37.5 mg QD § bezuclastinib 300 mg or Selected 600 mg QD + sunitinib Dose 37.5 mg QD* PART 1b BEZUCLASTINIB/SUNITINIB DRUG-DRU
Slide 6: Peak Study Objectives and Endpoints for Part 2; Key Entry Criteria
Peak Study Objectives and Endpoints for Part 2 Key Entry Criteria for Part 2 Determine the efficacy of bezuclastinib + sunitinib vs sunitinib alone as second-line Histologically confirmed Gastrointestinal Stromal Primary Objective treatment in adult patients with GIST who were intolerant to imatinib
Slide 7: Part 1b Drug-Drug Interaction: Objective, Design, Results
• Primary Objective: – To characterize potential drug-drug interaction between bezuclastinib and sunitinib • Design: – Subjects (n = 23) were randomized 1:1 to receive monotherapy (either sunitinib or bezuclastinib) for 2 weeks followed by combination • Results: – Combination with sunitinib did not
Slide 8: TEAEs ≥15% of Patients All Causality
TEAEs≥15% of Patients All Causality • Majority of TEAEs were of low CTCAE grade and reversible. Part 1a Part 1b Total • Low rate (38%) of Grade 3+ events n=19 (%) n=23 (%) n=42 (%) Preferred Term All Grade Grade ≥3 All Grade Grade ≥3 All Grade Grade ≥3 • Only three patients experienced serious adver
Slide 9: Peak Part 1 Evaluable Patients Efficacy
Peak Part 1 • Objective Response Rate (ORR) is 20% (6 confirmed PRs, 2 unconfirmed PR) Evaluable Patients^ (n=40) • Data remain immature to estimate median PFS for part 1 patients Prior Imatinib Only • Objective Response Rate is 33% (2 confirmed PRs) Evaluable Patients^ (n=6) • Durable disease contr
Slide 10: Efficacy, Safety and Conclusions
Efficacy • Objective response rate (ORR) in Part 1 (n=40) is 20%. o Durable disease control and responses have been observed across a range of bezuclastinib and sunitinib exposure. o Majority of 2nd-line patients remain on treatment past 12 months with a confirmed 33% ORR. Safety • Encouraging safet
Slide 11: Trial in Progress: Selected Countries for Peak Study
Selected Countries for Peak Study Trial in Progress PART 2 RANDOMIZED STUDY∂ N~388 bezuclastinib 600 mg QD + sunitinib 37.5 mg QD Prior Imatinib Only R 1:1 sunitinib 37.5 mg QD § Key Entry Criteria for Part 2 An electronic version of this • Histologically confirmed Gastrointestinal Stromal Tumors (G