Gritstone bio Announces Strengthening of Maturing Phase 2 PFS Data for GRANITE Study and Provides Business Update
-- 27% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.73 [90% CI, 0.44, 1.21]) --
-- 50% relative risk reduction of progression or death with GRANITE vs. control in low ctDNA subgroup (HR=0.50 [90% CI, 0.20-1.28]) --
-- Progressing through court-administered financial restructuring process with continued interest from multiple parties
“Our encouraging Phase 2 data for GRANITE in MSS-CRC continue to mature and demonstrate durable benefit over time. With two additional months of follow-up, relative progression-free survival has further improved in the analysis of all patients treated with GRANITE, and most notably, in those with a lower tumor burden at study baseline,” said
Key Findings from an Updated Interim Phase 2 Analysis in Front-Line Metastatic MSS-CRC
Data cut as of
An updated October analysis of progression-free survival (PFS) per RECIST v1.1 included an additional two months of follow-up.
- 28% (11/39) GRANITE and 13% (4/30) of control patients remain on study and free of progression vs. 33% (13/39) GRANITE and 23% (7/30) of control patients from August analysis; the majority of GRANITE patients still on study have undetectable ctDNA using Gritstone’s high-sensitivity, tumor-informed assay
- Clinical benefit improved compared to previous analysis in patients with low and high disease burden (based on ctDNA levels)
- Clinical benefit was most notable in patients with low disease burden at study entry
- Low baseline ctDNA levels (eg at study entry) is a likely prognostic and predictive factor
- Overall survival data remain immature, with mature data expected in 2H 2025
- GRANITE continues to demonstrate a favorable safety and tolerability profile
| Summary of Progression-Free Survival Results | ||
| Relative Risk Reduction; PFS Hazard Ratio* |
||
| October Analysis 2024 | August Analysis 2024 | |
| All patients n = 69 |
27%; 0.73, [90% CI, 0.44-1.21] |
21%; 0.79, [90% CI, 0.47-1.35] |
| ctDNA-lo^ n = 31 |
50%; 0.5, [90% CI, 0.20-1.28] |
43%; 0.57, [90% CI, 0.20-1.58] |
| ctDNA-hi^ n = 30 |
22%; 0.78, [90% CI, 0.39-1.58] |
13%; 0.87, [90% CI, 0.41- 1.86] |
| *The protocol-defined PFS analysis (per RECIST v1.1) is reported herein for all groups. An exploratory analysis using both radiographic and clinical progression data was reported for the ctDNA subgroups on ^Not all patients had baseline samples for analysis |
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Restructuring Process
On
Gritstone is continuing its sale process and actively pursuing bidders for all or any portion of the Company’s assets to continue research and development of its next-generation vaccines and immunotherapies for oncology and infectious diseases. The bid deadline for the sale process is
About the GO-010 Study
GO-010 (NCT05141721) is a Phase 2, randomized, open-label study designed to evaluate the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902), a neoantigen targeting immunotherapy, in combination with immune checkpoint inhibitors (ICI) in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone in patients with first-line microsatellite stable colorectal cancer (MSS-CRC). 104 patients were randomized 1:1 in the study: 69 patients (39 GRANITE arm, 30 control arm) are included in the treated analysis above. Demographics and clinical characteristics were balanced between arms (e.g., stage, sidedness, presence of liver metastases), with the vast majority (80%) of patients having liver metastases in the treated analysis. Thirty-five patients did not advance to study treatment after oxaliplatin most commonly due to withdrawing consent (n=15), disease progression (n=7), and other reasons (n=13) (12 in GRANITE arm; 23 in control arm).
About Gritstone bio
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to our clinical and regulatory development plans for our product candidates; our expectations regarding the data to be derived in our ongoing and planned clinical trials; statements regarding the process and potential outcomes of our chapter 11 case; our ability to continue to operate as usual during our chapter 11 case; the timing of commencement of our future nonclinical studies, clinical trials and research and development programs; our ability to discover, develop and advance product candidates into, and successfully complete, clinical trials; and our plans and strategy regarding maintaining existing and entering into new collaborations and/or partnerships. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Annual Report on Form 10-K filed on
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