Pancreatic Cancer and Small Cell Lung Cancer Program Updates
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) • • • Small Cell Lung Cancer (SCLC) •
Onvansertib SPECIFICITYPROPERTIES • • •
Line of Therapy Ph2 Ph3 Combination with:Trial IIT*
Targets with oncogenic alterations Targets without oncogenic alterations * ROS1 estimated eligible patients presented in Turning Point Therapeutics’ corporate presentation May 2022 slide 6 (NSCLC disease incidence in the US of 140k of which 2% of patients harbor ROS1 translocation). RET estimated eligible patients presented in Loxo Oncology’s corporate presentation January 2018 disclosed on Form 8-K (Jan 8, 2018). mCRC estimated population includes 1st line, KRAS- and NRAS-mutated cancers. mPDAC estimated population includes 1st line PDAC patients. SCLC estimated population includes SCLC salvage patients. TNBC estimated population includes invasive, 2nd line TNBC patients. 53 15 12 5050 48 Annual eligible U.S. patients (’000s)*
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Small Cell Lung Cancer (SCLC)
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
14 DAY CYCLE ENROLLMENT CRITERIA OBJECTIVE PRIMARY ENDPOINT SECONDARY ENDPOINT
Confirmed PR Waiting for confirmatory scan
Confirmed PR Waiting for confirmatory scan
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
• • OBJECTIVESENROLLMENT CRITERIA
Patient 28 (tumor responder) 0 10 20 30 0k 50k 100k 150k Patient 33 (tumor non-responder) 0 10 20 30 40 0 500 1000 1500 • •
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
ENROLLMENT CRITERIA 28 DAY CYCLE TWO LEAD-IN COHORTS SUBSEQUENT CHEMO + ONVANSERTIB TREATMENT* • • PRIMARY ENDPOINT SECONDARY ENDPOINTS
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Small Cell Lung Cancer (SCLC)
TRIAL RATIONALE
ENROLLMENT CRITERIA 21 DAY CYCLE PRIMARY ENDPOINT SECONDARY ENDPOINTS OBJECTIVE
ENROLLMENT CRITERIA PRELIMINARY EFFICACY (N=7) PRELIMINARY SAFETY (N=6)
Baseline Scan Restaging after Cycle 2
20252023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1st line mCRC randomized data readout mPDAC data readout SCLC data readout
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) • • • Small Cell Lung Cancer (SCLC) •
