Renovorx, Inc. · NASDAQ:RNXT
Renovorx — Technical Presentation (2023)
19 slides from Renovorx's technical presentation, 2023
Slide 1: The Phase 3 Study: Targeted Intra-Arterial Gemcitabine vs. IV Gemcitabine plus Nab-Paclitaxel (TIGeR-PaC)
The Phase 3 Study: Targeted Intra-Arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel Following Induction with Sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC) First Interim Analysis Dr. Michael Pishvaian1, Dr.
Slide 2: Disclosures (3 years)
Disclosures (3 years) Consultant/Advisory Board/Steering Committee: • AstraZeneca, Merck, Pfizer, Novartis, Ideaya, Astellas, Trisalus, Pionyr, Seattle Genetics, Merus Travel, accommodations, and expenses support: • Astellas, RenovoRx Stock/Ownership: • Perthera, Tumor Board Tuesdays, TRICC Research
Slide 3: Locally Advanced Pancreatic Cancer (LAPC)
Locally Advanced Pancreatic Cancer (LAPC) • Pancreatic cancer is soon to be the second leading cause of cancer-related death in the United States • 30% - 35% of pancreatic cancer patients present with locally advanced disease • While 10-15% of patients with LAPC have their disease rendered surgicall
Slide 4: Survival in Locally Advanced Pancreatic Cancer
Survival in Locally Advanced Pancreatic Cancer Prospective Trials The current standard of care therapies for patients with LAPC have led to a median overall survival of 9.3 – 19.2 months Prospective Trials 2009 N=30 German LAPC Phase 2 RT-5FU 9.6 months N=32 German LAPC Phase 2 RT-Gem-cis 9.3 months
Slide 5: Chemotherapy is Not Effectively Delivered to Primary Pancreatic Tumors
Chemotherapy is Not Effectively Delivered to Primary Pancreatic Tumors Dense fibrotic stroma | Sparse tumor cellularity | Hypovascular tumors Liver tumors are vascularized Pancreas tumors are hypovascular • Large tumor feeders – excellent targets for therapy • Inability to identify tumor feeder vess
Slide 6: Trans-Arterial Micro-Perfusion (TAMP)
Trans-Arterial Micro-Perfusion (TAMP) Mechanism: after vessel isolation, increase in pressure forces drug across the artery wall into the micro- Increases Drug Concentration to Target Pathological Site vasculature into tumor tissue by ~100X* Compared to IV Administration* Tissue Concentration Gem. (
Slide 7: TAMP in Pancreatic Cancer: Registry Study to Explore Clinical Endpoints
TAMP in Pancreatic Cancer: Registry Study to Explore Clinical Endpoints RR1- Dose Escalation RR1 + RR2 Combined Data+ RR2 – Observational Safety Study* Registry • Primary Endpoint: Safety, MTD • Primary endpoints: • Secondary Endpoint: OS survival, tumor response • Completed July 2016 • 6 centers In
Slide 8: TIGeR-PaC RCT
TIGeR-PaC RCT Trans(Intra)-arterial Gemcitabine vs. Continuation of IV Gemcitabine and Nab-Paclitaxel following Radiotherapy for Locally Advanced Pancreatic Cancer TIGeR-PaC RCT– study to test the efficacy of TAMP approach as part of a phase III randomized clinical trial
Slide 9: Objectives
Objectives Primary Objective • Overall Survival from the time of randomization Secondary Objectives • Overall survival for treatment received and non-surgical populations • Progression Free Survival • Objective response rate and duration of response • Health Related Quality of Life assessed with the
Slide 10: Statistics and Major Inclusion/Exclusion Criteria
Statistics and Major Inclusion/Exclusion Criteria Statistical Design Inclusion • Primary endpoint: Overall Survival from the time of randomization 1. Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 • Study designed to have a 80% power to detect a hazard ratio of we
Slide 11: Phase III TIGeR-PaC Study Design
Phase III TIGeR-PaC Study Design INDUCTION PHASE 1:1 RANDOMIZATION PHASE 4-Months of Treatment with: Continuation IV Gemcitabine + Nab-Pac (SOC) vs IA Gemcitabine IV Gemcitabine 1º Endpoint IV Gemcitabine + Nab-Pac (SOC) Control + Nab-Pac Overall 2 months Survival 4 months, 12 total infusions Contin
Slide 12: TIGeR-PaC First Interim Analysis
TIGeR-PaC First Interim Analysis First Interim analysis Feb 2023 – after 30% (26) of all events (deaths) occurred At the first interim analysis: IV Gemcitabine IA Gemcitabine Baseline Characteristics+ + Nab-Pac (n = 23) • 45 patients randomized: 23 (n = 22) intra-arterial gemcitabine vs. 22 intraven
Slide 13: The PK analysis subset of TIGeR-PaC
The PK analysis subset of TIGeR-PaC Plasma levels of gemcitabine after intra-arterial (IA) gemcitabine vs. intravenous gemcitabine (IV) + nab-pac delivery From the 15 patient substudy, results for 13 patients were available (7 IA, 6 IV) Peak Plasma Levels Drug Exposure IA vs. IV Route Delivery Rate
Slide 14: Tolerability and Safety of Treatment
Tolerability and Safety of Treatment Tolerability during active treatment: • 61% of IA patients received all planned treatments at the pre-specified dose vs. 18% of IV (primarily due to AEs or SAEs) • Patients receiving IA therapy had more nausea and abdominal pain events • Patients receiving IV the
Slide 15: Primary Endpoint: Overall Survival
Primary Endpoint: Overall Survival IA IV Gemcitabine Gemcitabine + Nab-Pac Patients n = 23 n = 22 IA Gemcitabine Median OS, months 15.7 10.1 SURVIVING PROBABILITY (95% CI) HR (95% CI) 0.48 (0.2-1.12) P value p<0.08 IV Gemcitabine + Nab-Paclitaxel Censored # of Subjects at Risk STUDY MONTH * ITT Popu
Slide 16: Secondary Endpoint: Progression-Free Survival
Secondary Endpoint: Progression-Free Survival* IA IV Gemcitabine Gemcitabine + Nab-Pac Patients n = 23 n = 22 Median PFS, months SURVIVING PROBABILITY 14.8 6.7 (95% CI) IA Gemcitabine HR (95% CI) 0.55 (0.21-1.47) IV Gemcitabine + Nab-Paclitaxel Censored # of Subjects at Risk STUDY MONTH * ITT Popula
Slide 17: Estimated Overall Survival from Diagnosis
Estimated Overall Survival from Diagnosis Data on 45 patients randomized INDUCTION RANDOMIZED TREATMENT & FOLLOW-UP s • 23 randomized to IA gemcitabine • 22 randomized to IV gem + nab-pac Proportion of Participants Still Alive Median Overall Survival (OS) Difference: 6-months IA Gemcitabine IV Gem +
Slide 18: Conclusions
Conclusions At the first interim analysis: • Overall survival for patients treated with intra-arterial gemcitabine was 16 months from randomization compared to only 10 months for patients who continued intravenous gem + nab-pac • Progression-free survival for patients treated with intra-arterial gem
Slide 19: Acknowledgements
Acknowledgements • The patients and their families for making this trial possible • The clinical study teams and their investigators for their work and contribution • This study is supported by RenovoRx • All authors contributed to and approved this presentation