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 Presented at the 2023 ESMO World Congress on Gastrointestinal Cancer
June 28, 2023 at 03:48 am IST
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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. Amer Zureikat2, Dr. Paula Novelli2, Dr. Charles Lopez3, Dr. Kenneth Meredith4, Dr. Emmanuel Zervos5, Dr. Hassan Hatoum6, Dr. Ki Chung7, Dr. Daniel J. Berg8, Dr. Antonio Ucar9, Dr. Ripal Gandhi9, Dr. Reza Nazemzadeh10, Dr. Nainesh Parikh11, Dr. Christopher Laing12, Dr. Brian Boone13, Dr. Thor Johnson14, Dr. Susan Bates15, Dr. Karyn Goodman16, Dr. Brian Kouri10, Dr. Ramtin Agah17
Johns Hopkins University School of Medicine, NMCR Kimmel Cancer Center at Sibley Memorial Hospital, Washington, D.C., United States,2 UPMC Hillman Cancer Center, Pittsburgh, PA, United States, 3 Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, United States, 4 Sarasota Memorial Hospital, Sarasota, FL, United States, 5 East Carolina University, Greenville, North Carolina, United States, 6 University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 7 Prisma Health Cancer Institute in Greenville, SC, United States, 8 University of Iowa, Iowa City, Iowa, United States, 9 Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, United States, 10 Atrium Health Levine Cancer Institute, Charlotte, NC, United Stated, 11 Moffitt Cancer Center, Tampa, FL, United States, 12 Sutter Medical Center, Sacramento, CA, United States, 13 West Virginia University, Morgantown, West Virginia, United States , 14 Medical University of South Carolina, Charleston, South Carolina, United States, 15 Columbia University Medical Center, New York, NY, United States, 16 Icahn School of Medicine at Mount Sinai, New York, NY, United States, 17 RenovoRx Inc. Los Altos, CA, United States
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 surgically operable (with an R0 resection), the vast majority of patients have incurable disease
The current standard of care therapies for patients with LAPC have led to a median overall survival of ~15 months
Rahib L, et al, Cancer Res. 2014 Jun 1;74(11):2913-2; Park W, Chawla A, O'Reilly EM, JAMA. 2021 Sep 7;326(9):851-862
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
N=31
German LAPC Phase 2
RT-Gem-cisà gem-cis
7.3 months
2011
N=69
MDACC Phase 2
Cetux-Gem-Cisà RT+cetux
19.2 months
2016
N=223
LAP 07 Phase 3
Gemcitabine
13.6 months
N=219
LAP 07 Phase 3
Gemcitabine + erlotinib
11.9 months
2020
N=107
LAPACT Phase 2
Gemcitabine + nab-pac
18.8 months
Wilkowski R, Br J Cancer. 2009 Dec 1; 101(11): 1853-1859;Crane D, JCO. 2011 Aug 1; 29(22): 3037-3043;
Hammel P, JAMA. 2016;315(17):1844-1853; Philip PA, et al, Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294
Large tumor feeders - excellent targets for therapy
• Inability to identify tumor feeder vessels and penetrate
•
Large branches within tumor - easily visualize tumor
drug into the tumor
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RenovoRx Inc. published this content on 27 June 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 June 2023 22:17:35 UTC.
RenovoRx, Inc. is a clinical-stage biopharmaceutical company. The Company is developing targeted combination therapies for high unmet medical needs with a goal of improving therapeutic outcomes for cancer patients undergoing treatment. Its Trans-Arterial Micro-Perfusion (TAMP) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapyâs toxicities versus systemic intravenous therapy. Its portfolio of cancer therapies is based on its lead product candidate, RenovoGem (gemcitabine delivered via its delivery system). Its phase III lead product candidate, RenovoGem, is a novel oncology drug-device combination product. RenovoGem is being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research. Its phase III registrational trial of RenovoGem for the treatment of LAPC is called 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 Presented at the 2023 ESMO World Congress on Gastrointestinal Cancer