Gritstone Announces Updated Overall Survival Results in Advanced Colorectal Cancer Patients from Phase 1/2 Study of GRANITE and Trial in Progress Poster at ASCO
May 31 2022 - 8:00AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company that aims to develop the world’s most potent vaccines,
today announced updated overall survival (OS) results from its
Phase 1/2 study evaluating GRANITE, an individualized vaccine-based
immunotherapy, to treat advanced solid tumors. Additionally, the
company announced it is presenting a “Trial in Progress” poster
summarizing the Phase 2/3 GRANITE-CRC-1L- study (randomized study
for first-line maintenance treatment of metastatic, microsatellite
stable colorectal cancer) at the 2022 American Society for Clinical
Oncology (ASCO) Annual Meeting.
“The updated OS data from our Phase 1/2 study continue to
demonstrate a correlation between molecular response and overall
survival, and points to the potentially significant impact GRANITE
is having on lives of patients with advanced stage cancer,” said
Andrew Allen, M.D., Ph.D., Co-founder, President and Chief
Executive Officer of Gritstone. “The median overall survival
observed in multiple trials of various therapies in the third-line
MSS-CRC setting has been around 6-7 months, which is consistent
with what we observed in our study in patients who did not have
molecular response (median overall survival of 7.8 months). The
very different outcome observed in the molecular responder subset,
with median overall survival of over 18 months, is all the more
striking given how rarely long-term survival is observed in MSS-CRC
patients who have been treated with and progressed on two prior
therapies. These maturing data, demonstrating long-term clinical
benefit, further support moving GRANITE upstream in the treatment
of patients with this grim cancer in the ongoing randomized Phase
2/3 study, which has registrational intent.”
The Phase 1/2 study is evaluating the safety, immunogenicity,
and clinical activity of GRANITE in combination with PD-1
checkpoint inhibitor, Opdivo® (nivolumab) and subcutaneous
anti-CTLA-4 antibody, Yervoy® (ipilimumab) in advanced solid
tumors. This study enrolled and treated 26 patients as of ESMO 2021
presentation with previously treated, metastatic solid tumors
including patients with colorectal cancer, gastroesophageal
adenocarcinoma, and non-small cell lung cancer. As presented at
ESMO 2021, of 9 patients with MSS-CRC who were treated and
evaluable for molecular response, 4 experienced a molecular
response (as evidenced by a reduction in circulating tumor DNA
[ctDNA]) and continue to have an OS advantage compared to those
patients who did not have a molecular response.
Opdivo® and Yervoy® are trademarks of Bristol-Myers Squibb
Company.
Updated overall survival data from GRANITE Phase 1/2:
- 4 of 9 treated patients with MSS-CRC had a molecular response
(as reported during the ESMO 2021 data presentation) and the
observed median overall survival in this group will now exceed 18
months (median OS not yet reached versus 7.8 months in those who
did not have a molecular response).
- All patients with MSS-CRC assessed for molecular response and
alive at the time of the ESMO 2021 data presentation remain alive
after an additional 35 weeks of follow-up.
ASCO presentation details are as follows:
Abstract TPS3635:
Phase 2/3, randomized, open-label study of an
individualized neoantigen vaccine (self-amplifying mRNA and
adenoviral vectors) plus immune checkpoint blockade as maintenance
for patients with newly diagnosed metastatic colorectal cancer
(GRANITE)Date/Time: Saturday 04 June 2022, 8:00am
CSTSession: Gastrointestinal Cancer – Colorectal and AnalLocation:
Poster 425b
About Gritstone bioGritstone bio, Inc. (Nasdaq:
GRTS) is a clinical-stage biotechnology company that aims to create
the world’s most potent vaccines. We leverage our innovative
vectors and payloads to train multiple arms of the immune system to
attack critical disease targets. Independently and with our
collaborators, we are advancing a portfolio of product candidates
to treat and prevent viral diseases and solid tumors in pursuit of
improving patient outcomes and eliminating disease.
www.gritstonebio.com
About GRANITE-CRC-1L Phase 2/3 TrialThe
GRANITE-CRC-1L trial (NCT05141721) is a Phase 2/3, randomized,
open-label study evaluating the GRANITE individualized
vaccine-based 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.
Gritstone Forward-Looking StatementsThis press
release contains forward-looking statements, including, but not
limited to, statements related to the potential of Gritstone’s
therapeutic programs; the advancements in Gritstone’s ongoing
clinical trials; the timing of data announcements related to
ongoing clinical trials and the initiation of future clinical
trials. 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’ early
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 Gritstone in general, see
Gritstone’s most recent Quarterly Report on Form 10-Q filed on May
5, 2022 and Gritstone’s future reports to be filed with the
Securities and Exchange Commission. The forward-looking statements
in this press release are based on information available to
Gritstone as of the date hereof. Gritstone disclaims any obligation
to update any forward-looking statements, except as required by
law.
Gritstone ContactsInvestors:George E.
MacDougallDirector, Investor Relations & Corporate
CommunicationsGritstone bioIr@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
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