Verastem, Inc. · NASDAQ:VSTM
Verastem — Investor Presentation (January 2025)
67 slides from Verastem's investor presentation, Jan 23, 2025
Slide 1: Delivering Novel Therapies for RAS/MAPK Pathway Driven Cancers
Delivering Novel Therapies for RAS/MAPK Pathway Driven Cancers January 2025 Corporate Presentation
Slide 2: Disclaimers: Forward-Looking Statements
2 Disclaimers Forward-Looking Statements This presentation includes forward-looking statements about, among other things, Verastem Oncology’s (the “Company”) programs and product candidates, strategy, future plans and prospects, including statements related to the anticipated timing of a potential l
Slide 3: Verastem Oncology: Preparing to Commercialize First Novel RAS/MAPK/FAK Combo Asset
3 Verastem Oncology: Preparing to Commercialize First Novel RAS/MAPK/FAK Combo Asset with Billion-Dollar Addressable Market Opportunity Avutometinib and defactinib combo has the potential to become the first and only FDA approved treatment for recurrent KRAS mutant Low-Grade Serous Ovarian Cancer (L
Slide 4: Efficiently Scaled Launch Model for Recurrent KRAS mutant LGSOC
4 Efficiently Scaled Launch Model to Deliver Best-in-Class Launch for Recurrent KRAS mutant LGSOC in Mid-2025 Mid-year Launch June 30, 2025 PDUFA Date Potential New Standard of Care Significant Market Opportunity Avutometinib plus defactinib is differentiated on multiple efficacy measures, favorable
Slide 5: Avutometinib and Defactinib Mechanism of Action
5 • 70% of LGSOC tumors are driven by RAS/MAPK pathway-associated mutations1-4 • 30% are KRAS mutant with other mutations including NRAS, BRAF, NF1, and other RAS pathway-associated gene mutations • Avutometinib is an oral RAF/MEK clamp that potently inhibits MEK kinase activity while also blocking
Slide 6: Clinical Program Designed to Address LGSOC and Beyond
6 Clinical Program Designed to Address LGSOC and Beyond Trial/Regimen Discovery Phase IND-Enabling/ Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Avutometinib + Defactinib: Recurrent LGSOC RAMP 301 RAF/MEK Clamp + FAKi vs ICT Complete enrollment in RAMP 301 by end of 2025 RAMP 201 RAF/M
Slide 7: Avutometinib Plus Defactinib Near-Term Growth, Pipeline Long-Term Growth
7 Anchor: Potential to bring avutometinib and defactinib combo as the first and only FDA approved treatment for recurrent KRAS mutant LGSOC in 2025 Maximize Potential: Expand market indications with avutometinib plus defactinib in first-line metastatic pancreatic cancer and advanced lung cancer Futu
Slide 8: Avutometinib and Defactinib in Recurrent LGSOC
8 Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) PDUFA Action Date: June 30, 2025 Potential Launch in Recurrent KRAS mutant LGSOC in mid-2025 Amanda, real patient living with recurrent LGSOC Diagnosed at 26 with LGSOC
Slide 9: Avutometinib + Defactinib Demonstrated Durable Results in RAMP 201
9 Avutometinib + Defactinib Demonstrated Durable Results Across Various Efficacy Measures in Heavily Pretreated Patients in RAMP 201 • 31% Overall ORR, 44% in KRAS mt, 17% in KRAS wt • 82% of all patients had tumor shrinkage • 14.5 months estimated mean DoT, 18.3 months in KRAS mt and 10.7 months in
Slide 10: High Unmet Need in Recurrent LGSOC
10 High Unmet Need for an Effective & Tolerable Therapy in Recurrent LGSOC “When you get told that you have a recurrence, the mental load is a lot. You’re thinking, okay, what did I have to do for treatment the first time? Now I have to repeat that. And will there even be something available for me
Slide 11: RAMP 201 Study Design
11 Key Inclusion Criteria • Recurrent LGSOC • Prior chemotherapy • Measurable disease (RECIST 1.1) • Prior MEKi allowed Avutometinib + Defactinib 3.2 mg BIW 200 mg BID KRAS mt (n=20) KRAS wt (n=22) Avutometinib + Defactinib 3.2 mg BIW 200 mg BID KRAS mt (n=22) KRAS wt (n=20) Avutometinib + Defactini
Slide 12: Avutometinib + Defactinib Regimen Results Across Parts
12 Avutometinib (3.2 mg BIW) + Defactinib (200 mg BID) Regimen Parts A+B+C ORR: 31% overall 44% in KRAS mt 17% in KRAS wt Low-Dose: Avutometinib (1.6 mg BIW) + Defactinib (200 mg BID) Part D • Disease progression by 4 months 22% in Low-Dose Part D • Disease progression by 4 months 12% with Go-Forwar
Slide 13: RAMP 201 Baseline Patient Characteristics
13 RAMP 201: Parts A+B+C Baseline Patient Characteristics Avutometinib + Defactinib Regimen 3.2 mg BIW + 200 mg BID 3 weeks on / 1 week off* All patients N=115 KRAS mt N=58 KRAS wt N=57 Age (years), Median (min, max) 54 (21, 87) 60 (29, 87) 45 (21, 80) ECOG PS, n (%) 0 78 (68) 42 (72) 36 (63) 1 37 (
Slide 14: Response Rate: Parts A, B, and C
14 Response Rate: Parts A, B, and C Avutometinib + Defactinib Regimen 3.2 mg BIW + 200 mg BID 3 weeks on / 1 week off All patients N=109 KRAS mt N=57 KRAS wt N=52 Confirmed* ORR, n (%) 34 (31) 25 (44) 9 (17) CR 2 (2) 2 (4) 0 PR 32 (29) 23 (40) 9 (17) SD† , n (%) 62 (57) 28 (49) 34 (65) PD, n (%) 9 (
Slide 15: Duration of Response
15 Median time to response (range, 1.7-19.2) 3.7 MONTHS DOR for KRAS mt and 63% for KRAS wt at 6 months 87% Avutometinib + Defactinib 3.2 mg BIW + 200 mg BID 3 weeks on / 1 week off All Patients N=34 KRAS mt N=25 KRAS wt N=9 DOR (mo), median (range) 31.1 (14.8, 31.1) 31.1 (14.8, 31.1) 9.2 (5.5, NE)
Slide 16: Best Overall Response
16 -100 -90 -80 -70 -60 -50 -40 -30 -20 -10 0 10 20 30 40 50 Best Target Lesion Response Per IRC (% Change From Baseline) 110 120 Best Target Lesion Response Per IRC (% Change From Baseline) Avutometinib + Defactinib Regimen: Best Overall Response 82% of All Patients Had a Reduction in Target Lesion
Slide 17: ORR by Key Subgroups
17 Avutometinib + Defactinib Regimen: ORR by Key Subgroups Source for all data: RAMP 201 data cut off as of June 30, 2024; Bars show 95% confidence intervals Receiving Avutometinib and Defactinib Earlier in the Course of Therapy was Associated with Higher Rates of Response 0 10 20 30 40 50 60 n=63 n
Slide 18: Progression Free Survival
18 88% in KRAS mt and 69% in KRAS wt 79% OVERALL 62% in KRAS mt and 53% in KRAS wt 58% OVERALL Patients Achieved an Overall mPFS of 12.9 Months Avutometinib + Defactinib Regimen: Progression Free Survival (PFS) PFS, median (95% CI) Total N=109 KRAS mt N=57 KRAS wt N=52 12.9 mos (10.9, 20.2) 22 mos (
Slide 19: Low Discontinuation Rate Due to Adverse Events
19 Median follow-up = 13.6 mo (range, 1.4 – 39.5) Source for all data: RAMP 201 data cut off as of June 30, 2024; *Other includes: clinical progression (n=8) and progression confirmed by biopsy/pathology report, progression by confirmation of cytology from pleural effusion showing malignant etiology
Slide 20: Well-Tolerated Safety Profile
20 Avutometinib Plus Defactinib Continue to Demonstrate a Well-Tolerated Safety Profile Severe adverse events are generally uncommon and typically managed by a treatment pause 10% (12/115) discontinued for AEs (any cause); most common increased CPK (n=4) 80% (92/115) had AEs leading to dose interrup
Slide 21: RAMP 301: Phase 3 International Confirmatory Trial
21 RAMP 301: First Randomized Prospective Study to Fully Characterize KRAS Status of all Enrolled LGSOC Patients • Patients enrolling are similar to patient population in RAMP 201, with recurrent KRAS mt and KRAS wt LGSOC; prior MEKi and bevacizumab use allowed and post one line of platinum chemothe
Slide 22: Changing the Treatment Paradigm in Recurrent LGSOC
22 Changing the Treatment Paradigm in Recurrent LGSOC PDUFA Action Date: June 30, 2025 Potential Launch in Recurrent KRAS mutant LGSOC in mid-2025
Slide 23: 80% of Patients with LGSOC Recur and Cycle Through Treatments
23 Disproportionally affects younger women1 Pre-Diagnosis Nonspecific signs and symptoms2 Ultrasound and bloodwork3 Average delay up to 3 years4 Diagnosis Poor response rates of current treatments with high discontinuation rates 5,6 Treatment Symptom Progression &Testing Treatment After Recurrence P
Slide 24: Contemporary Clinical Trial Data in LGSOC
24 Trial Therapy Image assessment Response Rate ORR ORR KRAS mt ORR KRAS wt Median PFS Months (95% CI) mPFS KRAS mt mPFS KRAS wt Discontinuati on Rate due to AEs GOG 2811 SoC (n=130) (n=22 KRAS/NRAS/ BRAF mt; n=42 KRAS/NRAS/ BRAF wt) INV 6% 95% CI: (3%, 12%) 9.1%, 95% CI: (1.9%, 26.1%) 7.1%, 95% CI:
Slide 25: Combo Has Potential to Address Key Treatment Needs
25 To date, avutometinib + defactinib combination data in recurrent LGSOC show1 : Clinically meaningful response rates and durable benefit in both KRAS mutant and wild-type tumors Long progression-free survival and duration of treatment 1Data from RAMP 201 study June 30. 2024 cutoff; 2Chenard-Poirie
Slide 26: LGSOC Represents a Significant Market Opportunity
26 LGSOC Represents a Significant Market Opportunity 1. Estimated total addressable market opportunity based on incident / prevalent populations, average duration of therapy (as observed in VSTM clinical trials) and cost of therapy of $34,000 per month, consistent with other recent oncology drug lau
Slide 27: NCCN Recommendations and Contemporary Clinical Data in LGSOC
27 NCCN Category 1 NCCN Category 2a NCCN Category 2b NCCN Category 3 General % Commercial Payer Coverage Recurrent LGSOC Treatment NCCN Recommendations and Contemporary Clinical Data in LGSOC No category 1 recommendation • 6-13% ORR and 17-30% discontinuation rate due to AEs • Based on GOG 281 and M
Slide 28: Efficiently Scaled Launch Model
28 • Patient support and access programs • Best-in-class multichannel marketing • NPP pull through and reinforcement to targeted customers and white space territories • Inside Sales Reps will bolster Field Force efforts • More than 2,500 patients have registered on disease education website2 • Robus
Slide 29: Potential to Change Treatment Paradigm and Improve Patient Outcomes
29 Current available therapies offer limited efficacy, relatively high discontinuation rates due to AEs; no FDA-approved therapies and no active promotion NCCN guidelines help to drive treatment decision; will submit entire RAMP 201 dataset for NCCN consideration Avutometinib in combination with def
Slide 30: Next Steps in LGSOC Clinical Program and NDA
30 Next Steps in LGSOC Clinical Program and NDA Complete enrollment in RAMP 301 Phase 3 confirmatory study by end of 2025 Report initial data from the RAMP 201J Phase 2 clinical trial being conducted in Japan in H2 2025 Publish RAMP 201 primary analysis for all patients and then submit for NCCN cons
Slide 31: Potential Market Expansion in Pancreatic and Lung Cancer
Avutometinib ± Defactinib Potential Market Expansion Opportunities in First-line Metastatic Pancreatic Cancer and Advanced Lung Cancer
Slide 32: Topline Data from RAMP 205 in First-Line Metastatic Pancreatic Cancer
Topline Data from RAMP 205: Avutometinib + Defactinib + SOC in First-Line Metastatic Pancreatic Cancer
Slide 33: RAMP 205 Study Design
33 RAMP 205: Designed to Identify and Evaluate RP2D in Combination with Chemotherapy for Treatment of Newly Diagnosed mPDAC Inclusion Criteria Part A: Dose Evaluation (3+3 DLT Assessment) Part B: Dose Expansion (Primary Endpoint: ORR) • Histologic or cytologic confirmed metastatic pancreatic ductal
Slide 34: RAMP 205: Initial Interim Safety and Efficacy Results
34 RAMP 205: Initial Interim Safety and Efficacy Results • Encouraging early interim data from ongoing Phase 1/2 RAMP 205 study evaluating avutometinib + defactinib + gemcitabine + Nab-paclitaxel in first-line metastatic pancreatic cancer • As of data cutoff of May 14, 2024, Dose Level 1 mature with
Slide 35: Landmark Trials in First-Line Metastatic Pancreatic Cancer
35 Landmark Trials in First-Line Metastatic Pancreatic Cancer Trial/PI/Reported (# Patients) Intervention Comparator ORR by Investigator (95% CI) mPFS (95% CI) mOS (95% CI) MPACT Von Hoff 2013 (N=861) Gem/NabP* (n=431) Gem (n=430) Gem/NabP 5.5 months (4.5-5.9) 8.5 months (7.89-9.53) 29% (25-34) 23%
Slide 36: RAMP 205: Evaluating Multiple Regimens in Parallel
36 RAMP 205: Evaluating Multiple Regimens in Parallel to Efficiently Identify RP2D in First-Line mPC Duration of Treatment for All Patients; Safety Population (n=41) Data Cutoff Date:14 MAY 2024 In Dose Level 1: • 1 of 6 patients achieved objective response by month 2 • 2 of 6 patients achieved obje
Slide 37: RAMP 205: Best Percent Change in Target Lesion
37 RAMP 205: Best Percent Change in Target Lesion Sum of Diameters Includes Patients Who Have Had At Least First Scan (n=26) Data Cutoff Date:14 MAY 2024 Threshold for PR Dose Level Avuto Defactinib Gem Nab-Pac Day 1, 8, 15 chemo dosing: -1 2.4 mg BIW 200 mg BID 800 mg/m2 100 mg/m2 1 2.4 mg BIW 200
Slide 38: RAMP 205 Treatment-Emergent Adverse Events
38 • Any grade TEAEs occurring in ≥20% or grade ≥3 occurring in ≥5% of patients1 DL-1 (n=11) DL1 (n=6) DL1a (n=12) DL2a (n=12) Total (N=41) Any Grade, n (%) Grade ≥3, n (%) Any Grade, n (%) Grade ≥3, n (%) Any Grade, n (%) Grade ≥3, n (%) Any Grade, n (%) Grade ≥3, n (%) Any Grade, n (%) Grade ≥3, n
Slide 39: Next Steps for RAMP 205
39 Next Steps for RAMP 205 Plan to report updated data in Q1 2025 Determine RP2D for expansion cohort in H1 2025 Present data from RAMP 205 trial at a medical meeting in mid-year 2025
Slide 40: Avutometinib ± Defactinib with Sotorasib in KRAS G12C NSCLC
Avutometinib ± Defactinib with Sotorasib (G12Ci) in KRAS G12C mutant NSCLC
Slide 41: FAK Inhibitor Augments Sotorasib + Avutometinib, Reverses Resistance in Preclinical Models
41 -100 0 100 200 300 400 Response at Day 10 Response @ Day 10 (% change from baseline) vehicle 10 PR avutometinib FAKi sotorasib sotorasib + avutometinib sotorasib + FAKi sotorasib + avutometinib + FAKi 1 SD 2 SD 1 SD 8 SD 2 PR 4 SD 3 PR 0 50 100 150 0 5 10 15 20 25 Days after first sotorasib dose
Slide 42: RAMP 203: Phase 1/2 Trial in KRAS G12C Advanced NSCLC
42 Cohort 1 Patients without Prior KRAS G12C Inhibitor Treatment Stage 1: ~20 patients Stage 2: expand to 54 Inclusion Criteria Part A: Dose Evaluation (3+3 DLT Assessment) Part B: Dose Expansion (Primary endpoint: ORR) • Documented KRAS G12C mutation determined using validated test • Treatment with
Slide 43: RAMP 203: No DLTs in First Triplet Combination Cohort
43 RAMP 203: No DLTs Were Observed in the First Triplet Combination Cohort in Patients Previously Treated with a G12C Inhibitor Triplet Combination Update: • As of a November 21, 2024, data cutoff, 3 patients whose cancer previously progressed on a G12C inhibitor have been treated with the triplet c
Slide 44: Next Steps for RAMP 203
44 Next Steps for RAMP 203 Complete enrollment in the KRAS G12C inhibitor prior-treated Stage 1 Part B doublet cohort in Q1 2025 Complete enrollment and evaluate the safety and efficacy of the triplet combination in H1 2025 Present an interim update at a medical meeting in H2 2025
Slide 45: Partnership with GenFleet Therapeutics on RAS Pathway Programs
Partnership with GenFleet Therapeutics on Novel, Potential Best-in-Class RAS Pathway Programs
Slide 46: KRAS G12D is the Most Frequent KRAS Mutation in Human Cancers
46 KRAS G12D is the Most Frequent KRAS Mutation in Human Cancers Adapted from Hofmann et al., Cancer Discovery 2022 • The only approved KRAS inhibitors target KRAS G12C which is largely restricted to NSCLC • KRAS G12D accounts for 26% of all KRAS mutations • KRAS G12D mutations are especially preval
Slide 47: Target Profile for a Best-in-Class KRAS G12D Inhibitor
47 Target Profile for a Best-in-Class KRAS G12D inhibitor Categories Criteria/Rationale ON/OFF Dual Inhibition Potent inhibition of both KRAS-GTP (ON) and KRAS-GDP (OFF) states for deep and durable inhibition of tumor growth Potency Inhibition of KRAS G12D signaling with sub-nanomolar potency KRAS G
Slide 48: Importance of Inhibiting Both ON and OFF States of KRAS
48 Importance of Inhibiting Both the Active (ON) & Inactive (OFF) States of KRAS for Deep and Durable Inhibition of Tumor Growth GEF GTP GDP GTP GDP RAS/MAPK pathway signaling GAP P KRAS OFF (inactive) KRAS ON (active) • KRAS-GTP is the active (ON) state which drives cancer growth • KRAS-GDP is the
Slide 49: VS-7375 is an Oral KRAS G12D (ON/OFF) Inhibitor
49 GEF GTP GDP GTP GDP VS-7375 KRAS G12D (ON/OFF) inhibitor RAS/MAPK pathway signaling GAP P KRAS OFF (inactive) KRAS ON (active) KRAS G12D State VS-7375 IC50 (nM) (KRAS G12D binding) GppNp-bound (ON/active) 2 1 GDP-bound (OFF/inactive) 6 1 VS-7375 is a dual inhibitor of ON (GTP) and OFF (GDP) state
Slide 50: VS-7375 Induces Tumor Regression in Multiple KRAS G12D Tumor Models
50 VS-7375 Induces Tumor Regression in Multiple KRAS G12D Tumor Models via Oral Administration 0 2 4 6 8 10 12 14 16 0 200 400 600 800 1000 Days after first dose Tumor volume (mm 3 , mean ± SEM) 0 2 4 6 8 10 12 14 16 0 500 1000 1500 2000 Days after first dose Tumor volume (mm 3 , mean ± SEM) 0 2 4 6
Slide 51: VS-7375 Addresses Key Criteria for a Best-in-Class G12D Inhibitor
51 VS-7375 Positively Addresses the Key Criteria for a Potential Best-in-Class G12D Inhibitor Categories Criteria/Rationale VS-7375* ON/OFF Dual Inhibition Potent inhibition of both KRAS-GTP (ON) and KRAS-GDP (OFF) states for deep and durable inhibition of tumor growth Yes IC50 = 2 nM (KRAS G12D ON)
Slide 52: VS-7375: Initial Oral Bioavailability and Clinical Activity
52 VS-7375: Initial Data Demonstrate Oral Bioavailability and Clinical Activity • 26 patients have been treated with VS-7375 in a Phase 1 dose escalation study being conducted in China1 • Both confirmed and unconfirmed partial responses have been observed, including patients with metastatic pancreat
Slide 53: VS-7375 Preclinical Properties Relative to Other G12D Inhibitors
53 VS-7375 Shows Potential Best-in-Class Preclinical Properties Relative to Other Known G12D Inhibitors Criteria VSTM/ GenFleet VS-7375 Mirati/BMS MRTX1133 RevMed RMC-9805 Lilly LY3962673 AZ AZD0022 Incyte INCB161734 Quanta QTX3046 Tyligand TSN1611 Betta BPI-501836 Hengrui HRS-4642 ON/OFF selectivit
Slide 54: Next Steps for VS-7375 & GenFleet Collaboration
54 Next Steps for VS-7375 & GenFleet Collaboration GenFleet plans to continue to enroll patients into Phase 1/2 trial for VS-7375/ GFH375 in China in patients with KRAS G12D-mutated advanced solid tumors Anticipate filing U.S. IND for VS-7375 during Q1 2025 and initiate a Phase 1/2a study in mid-202
Slide 55: Achievements, Anticipated Milestones & Financials
Achievements, Anticipated Milestones & Financials
Slide 56: Planned Near-Term LGSOC Commercial Launch, Followed by Meaningful Catalysts
56 Planned Near-Term LGSOC Commercial Launch, Followed by Meaningful Catalysts to Expand Into Larger, Underserved Patient Populations Program Anticipated Milestones & Activities Avutometinib + Defactinib in Recurrent Low-grade Serous Ovarian Cancer (LGSOC) ❑ Plan for June 30, 2025 PDUFA action date;
Slide 57: Key Financial Statistics
57 Key Financial Statistics Cash, cash equivalents & short-term investments $113.2M GAAP Operating Expenses $37.0M Non-GAAP Operating Expenses $35.1M* Shares Outstanding 40.3M** As of and for the quarter ended September 30, 2024 • Oberland Finance Credit Facility • Up to $150M available in a series
Slide 58: Thank You
Thank You
Slide 59: Addendum
Addendum
Slide 60: Avutometinib Patent Exclusivity
60 Avutometinib Patent Exclusivity Composition of Matter Method of Making Sept 2032 Dosing Protocol May 2038 Combination w/ Defactinib Dec 2042 Feb 2027 + 5 yrs (PTE) = 2032 Sept 2040 Solid Form PTE 2041 - 2042 if issued Methods or Treating; Combinations
Slide 61: Experienced Senior Management Team
61 Experienced Senior Management Team Previous experience: • CEO, The DNA Repair Co. (now On-Q-ity) • PharMetrics (now IMS) • Axion Daniel Paterson President and CEO Dan Calkins Chief Financial Officer Previous experience: • Technical Accounting Consultant- CFGI • PwC LLP Cathy Carew Chief Organizat
Slide 62: Avutometinib Monotherapy Provided Lower Rate of Response
62 Avutometinib Monotherapy Provided Lower Rate of Response • Patients enrolled had comparable baseline characteristics as patients randomized to avutometinib plus defactinib regimen • Median of 3 prior lines of therapy, 49% had prior bevacizumab, 26% had prior MEKi • ORR: 17% in all patients, 23% K
Slide 63: Low-Dose Regimen (Part D) Determined to be Suboptimal
63 Low-Dose Regimen (Part D) Determined to be Suboptimal Based on Pre-Defined Analysis Source for all data: RAMP 201 data cut off as of June 30, 2024; D/C discontinuation IRC Assessment Avutometinib 3.2 mg + 200 mg Defactinib Regimen 3 weeks on / 1 week off N=109 Avutometinib 1.6 mg + 200 mg Defacti
Slide 64: Optimized Dosing Schedule Defined
64 Optimized Dosing Schedule Defined: Favorable Tolerability Profile with Novel Intermittent Dosing Regimen Avutometinib monotherapy Daily at MTD N=6 28-day cycle RP2D Avutometinib monotherapy 4mg twice weekly N=26 28-day cycle RP2D (Avutometinib 3.2mg twice weekly + defactinib 200mg twice daily) N=
Slide 65: FDA Breakthrough Designation Based on FRAME Data
65 FDA Breakthrough Designation Based on FRAME Data Breakthrough Through Therapy Designation for combination of avutometinib and defactinib for treatment of recurrent LGSOC after one or more prior lines of therapy including platinum-based chemotherapy *Denis, 5th Annual RAS-Targeted Drug Development
Slide 66: RAMP 301 Study Design
66 • Confirmed LGSOC diagnosis • Recurrent disease after prior platinum therapy • Documented KRAS mutation status • Measurable disease per RECIST v1.1 • Prior MEKi allowed • Prior Bevacizumab allowed Inclusion Criteria 1:1 Randomization n = 270 Stratification Factors: KRAS mutation status (wt vs. mt
Slide 67: Ongoing Investigator-Sponsored Trials Across Tumor Types
67 Gynecologic 25%-96% biomarker Colorectal 45%-50% biomarker Melanoma 100% biomarker Thyroid 35% biomarker Breast 22.5% biomarke r • LGSOC: MSKCC Phase 1/2 with Avutometinib + Defactinib + Letrozole; 70% biomarker; Prevalence 6k1 • Gynecologic Basket: University of Oklahoma Phase 2 with Avutometini