Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC)
-- Phase 2/3 GRANITE-CRC-1L trial has registrational intent --
-- Updated data from Phase 1/2 trial in end-stage metastatic MSS-CRC further support the association of circulating tumor DNA (ctDNA) reduction with extended overall survival --
-- GRANITE has received Fast Track designation by the
“Building on the success of our GRANITE program, which continues to demonstrate extended survival in multiple end-stage colorectal cancer patients, we are excited to launch this randomized, open-label Phase 2/3 trial to evaluate earlier use of GRANITE as a maintenance treatment in newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer,” said
Additionally, the company reported updated overall survival (OS) data from its Phase 1/2 GRANITE trial evaluating individualized immunotherapy in combination with nivolumab (OPDIVO®) and ipilimumab (YERVOY®) in patients with advanced solid tumors, specifically end-stage metastatic MSS-CRC. Patients with MSS-CRC who experienced a molecular response (as evidenced by a decrease in circulating tumor DNA [ctDNA]) continue to have an OS advantage compared to those patients who did not have a molecular response. All patients alive at the time of the ESMO 2021 data presentation remain alive after an additional ~22 weeks of follow-up (
Gritstone will address these developments and present the updated OS data (from the Phase ½ trial in patients with advanced solid tumors) in a presentation at the 40th Annual
About GRANITE-CRC-IL Phase 2/3 Trial
The GRANITE-CRC-1L trial (NCT05141721) is a Phase 2/3, randomized, open-label study evaluating the GRANITE individualized immunotherapy regimen as a first line (1L) maintenance treatment in combination with atezolizumab (TECENTRIQ®) and ipilimumab (YERVOY®) in newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC) who received fluoropyrimidine, oxaliplatin and bevacizumab (FOLFOX-bevacizumab) induction therapy. The Phase 2 portion of the study will measure changes in ctDNA over time to characterize the clinical activity of maintenance therapy with GRANITE (GRT-C901/GRT-R902). The Phase 3 portion will further measure the clinical efficacy of the regimen as assessed by progression-free survival using iRECIST criteria.
About Phase 1/2 Trial Evaluating GRANITE Against Advanced Solid Tumors
The purpose of this study was to evaluate the safety, dose, immunogenicity and early clinical activity of the GRANITE individualized neoantigen cancer vaccine, in combination with OPDIVO® (nivolumab) and YERVOY® (ipilimumab), in patients with end-stage metastatic MSS-CRC, NSCLC, gastroesophageal adenocarcinoma, and urothelial cancer (NCT03639714).
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens that are identified by the company using its proprietary Gritstone EDGE™ artificial intelligence platform. GRANITE is an individualized neoantigen-based immunotherapy and uses a priming adenoviral vector (GRT-C901) and self-amplifying mRNA (samRNA) vector (GRT-R902) to deliver individualized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the
Gritstone Forward-Looking Statements
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