EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company
committed to developing and delivering innovative medicines to
patients at radically lower prices, today announced a late-breaking
oral presentation of updated data from the Phase 3 GEMSTONE-301
trial of sugemalimab in non-small cell lung cancer (NSCLC) at the
International Association for the Study of Lung Cancer (IASLC) 2022
World Conference on Lung Cancer (WCLC), taking place August 6
through August 9, 2022. These results are being featured in the
WCLC press program.
“In the updated results from GEMSTONE-301, sugemalimab
demonstrated a sustained progression-free survival benefit,
underscoring its potential as consolidation therapy for people with
locally advanced, unresectable Stage III non-small cell lung
cancer,” said Vince Miller, MD, physician-in-chief at EQRx. “The
inclusion of patients who had received sequential chemoradiotherapy
in this trial is of particular importance as patients often cannot
tolerate concurrent chemoradiotherapy or cannot access it due to a
variety of factors. There is currently no immune checkpoint
inhibitor approved as a consolidation option for these patients,
estimated to represent as many as 25% of people with unresectable
Stage III non-small cell lung cancer in the U.S.”
As of the March 2022 data cutoff, the final progression-free
survival (PFS) analysis of the Phase 3 GEMSTONE-301 trial showed
that sugemalimab continued to demonstrate improvement in PFS
compared to placebo as consolidation therapy for patients with
locally advanced, unresectable Stage III NSCLC without disease
progression after concurrent or sequential chemoradiotherapy.
Median PFS was 10.5 months for sugemalimab and 6.2 months for
placebo (hazard ratio [HR]=0.65, 95% CI 0.50–0.84, P=0.0012). PFS
benefit was observed in the sugemalimab arm over the placebo arm
regardless of whether patients received prior concurrent
chemoradiotherapy (15.7 vs. 8.3 months; HR=0.71, 95% CI: 0.50,
1.00) or sequential chemoradiotherapy (8.1 vs. 4.1 months; HR=0.57,
95% CI: 0.38, 0.87). Data for overall survival, a secondary
endpoint, were encouraging but immature at the time of the
analysis. The safety profile for sugemalimab was consistent with
previously reported results, and no new safety signals were
identified within the follow-up period.
GEMSTONE-301 previously met its PFS primary endpoint in May of
2021 and is the first positive Phase 3 trial of a PD-L1 agent in
this Stage III NSCLC patient population setting.1
On Sunday, August 7, these results are being featured in a WCLC
press conference at 4:10 a.m. ET and in an oral presentation at
6:22 a.m. ET during WCLC 2022 (abstract #OA02.05, “From Locally
Advanced to Unresectable NSCLC: Improvement of Multimodality
Treatment session”).*
About Non-small Cell Lung Cancer (NSCLC)Lung
cancer is the leading cause of cancer death for men and women
worldwide.2 Non-small cell lung cancer (NSCLC) is the most common
type of lung cancer, accounting for 85% of all lung cancer
diagnoses. The main subtypes of NSCLC are adenocarcinoma, squamous
cell carcinoma and large cell carcinoma.3 Treatment options for
NSCLC include surgery, radiation therapy, chemotherapy, targeted
therapy and immunotherapy.4
About the GEMSTONE-301 TrialGEMSTONE-301
(NCT03728556) is a randomized, double-blind, placebo-controlled
Phase 3 study designed to evaluate the efficacy and safety of
sugemalimab versus placebo as consolidation therapy for patients
with locally advanced, unresectable Stage III non-small cell lung
cancer (NSCLC) without disease progression after either concurrent
or sequential chemoradiotherapy. The study was conducted by CStone
Pharmaceuticals and included 381 patients who were randomized to
the sugemalimab group (n=255) or the placebo group (n=126). The
study met its primary endpoint, demonstrating statistically
significant and clinically meaningful improvement in
progression-free survival (PFS) compared to placebo as assessed by
blinded independent central review according to Response Evaluation
Criteria in Solid Tumors version 1.1. Secondary endpoints include
overall survival, investigator-assessed PFS and safety.
About Sugemalimab Sugemalimab is a monoclonal
antibody targeting programmed death-ligand 1 (PD-L1) that is
currently being investigated in several ongoing clinical trials,
including studies in relapsed or refractory extranodal natural
killer/T cell lymphoma (ENKTL), Stage III non-small cell lung
cancer (NSCLC), Stage IV NSCLC, gastric cancer and esophageal
cancer. In October of 2020, the U.S. Food and Drug Administration
(FDA) granted sugemalimab Breakthrough Therapy designation for the
treatment of adult patients with relapsed or refractory ENKTL.
Sugemalimab is approved by the National Medical Products
Administration (NMPA) of China for the treatment of patients with
unresectable Stage III NSCLC whose disease has not progressed
following concurrent or sequential platinum-based chemoradiotherapy
and in combination with chemotherapy for the first-line treatment
of patients with metastatic squamous and non-squamous NSCLC.
Sugemalimab was discovered by CStone Pharmaceuticals, and EQRx has
partnered with CStone Pharmaceuticals on the global development of
sugemalimab with the goal of expanding access worldwide. EQRx holds
the development and commercialization rights to sugemalimab outside
of Greater China.
About EQRxEQRx is a new type of pharmaceutical
company committed to developing and delivering innovative medicines
to patients at radically lower prices. Launched in January 2020,
EQRx is purpose-built, at scale, with a growing catalog of
medicines in development in high-cost drug categories and emerging
partnerships with leading payers and health systems. Leveraging
cutting-edge science and technology and strategic partnerships with
stakeholders from across the healthcare system, EQRx aims to
provide innovative, patent-protected medicines more efficiently and
cost-effectively than ever before. To learn more, visit
www.eqrx.com and follow us on social media:
Twitter: @EQRxInc, LinkedIn,
Instagram: @eqrxinc.
EQRx™ and Remaking Medicine™ are trademarks of EQRx.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains certain
forward-looking statements within the meaning of the federal
securities laws. These forward-looking statements may be identified
by the use of words such as “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “design,” “strategy,” “future,”
“opportunity,” “continue,” “aim,” “goal,” “plan,” “may,” “look
forward,” “should,” “will,” “would,” “will be,” “will likely
result,” and similar expressions. These forward-looking statements
include, but are not limited to, express or implied statements
regarding sugemalimab’s potential as a treatment option for NSCLC
and other diseases, EQRx’s ability to expand access to sugemalimab
worldwide with its partner CStone Pharmaceuticals, and EQRx’s
ability to develop and deliver innovative medicines at radically
lower prices. Forward-looking statements are predictions,
projections and other statements about future events that are based
on current expectations and assumptions and, as a result, are
subject to risks and uncertainties. Many factors could cause actual
future events to differ materially from the forward-looking
statements in this press release, including but not limited to the
inherent risks in pharmaceutical development, including with
respect to the conduct of clinical trials; delays of any current
and future clinical trials or the development of sugemalimab or
EQRx’s other drug candidates; risks that the results of prior
clinical trials may not be predictive of future results; risks
associated with successfully demonstrating the efficacy, safety and
tolerability of sugemalimab and obtaining regulatory approvals
therefor; EQRx’s ability to obtain, maintain and protect its
intellectual property; expectations regarding EQRx’s existing
collaborations with CStone Pharmaceuticals and its other existing
and future collaboration partners; risks associated with EQRx’s
ability to otherwise implement its business plans; changes in the
competitive and highly regulated industries in which EQRx operates,
including laws and regulations affecting EQRx’s business; and other
risks associated with its plans to create a new kind of
pharmaceutical company, among others. The foregoing list of factors
is not exhaustive. You should carefully consider the foregoing
factors and the other risks and uncertainties described in the
“Risk Factors” section in EQRx’s most recent Annual Report on Form
10-K as well as any other filings with the SEC. These filings
identify and address other important risks and uncertainties that
could cause actual events and results to differ materially from
those contained in the forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and EQRx assumes no obligation, and does not intend, to update or
revise these forward-looking statements, whether as a result of new
information, future events, or otherwise.
Investors and others should note that we communicate with our
investors and the public using our website www.eqrx.com, including,
but not limited to, company disclosures, investor presentations and
FAQs, SEC filings, press releases, public conference call
transcripts and webcast transcripts. The information that we post
on our website could be deemed to be material information. As a
result, we encourage investors, the media and other interested
parties to review the information that we post there on a regular
basis. The contents of our website shall not be deemed incorporated
by reference in any filing with the SEC.
EQRx Contacts:
Media:Dan Budwick 1ABdan@1abmedia.com
Investors:investors@eqrx.com
* EQRx and CStone Pharmaceuticals have partnered on the global
development of sugemalimab. This presentation will be shared by
CStone Pharmaceuticals and its collaborators.
1 Zhou Q, et al. The Lancet Oncology. Published January 14,
2022. doi: https://doi.org/10.1016/S1470-2045(21)00630-6.2 Sung H,
et al. CA Cancer J Clin. 2021;71(3):209-249. doi:
https://doi.org/10.3322/caac.216603 American Cancer Society. ”What
is Lung Cancer?” Accessed May 3, 2022. Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html.4
American Cancer Society. “Treating Non-Small Cell Lung Cancer.”
Accessed May 4 2022. Available at:
https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell.html
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