On January 13, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that the first patient has been enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial (Press release, Gritstone Oncology, JAN 13, 2022, View Source [SID1234605456]). The trial evaluates the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC). This trial has registrational intent and has been discussed previously with the FDA.
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"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 Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "We are pleased with the degree of clinical benefit seen with GRANITE to date in hard-to-treat, late-line CRC patients, and are optimistic we will see greater benefit from neoantigen immunotherapy in earlier lines of treatment where immune responses are likely stronger and tumor genomic complexity is lower. We expect to report initial Phase 2 data from the GRANITE-CRC-1L trial in mid-2023."
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 (Free ESMO Whitepaper) 2021 data presentation remain alive after an additional ~22 weeks of follow-up (January 5, 2022 data cut-off).
Dr. Allen continued, "These results reinforce our original observation that molecular response is associated with extended overall survival, the gold standard clinical outcome, in patients with advanced MSS-CRC. The fact that no new patient has succumbed to their disease after an additional ~22 weeks of observation and treatment is encouraging and would not typically be expected in third line CRC patients, for whom median overall survival is typically only around 26-30 weeks from initiation of therapy in multiple Phase 3 trials."
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 JP Morgan Healthcare Conference occurring at 8:15am ET today. To access this presentation, visit: View Source
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).
About GRANITE
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 U.S. Food and Drug Administration for the treatment of MSS-CRC.