EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company
committed to developing and delivering important new medicines to
patients at radically lower prices, along with its partner CStone
Pharmaceuticals, today announced that sugemalimab plus chemotherapy
demonstrated a statistically significant improvement in overall
survival (OS) compared to placebo plus chemotherapy as a first-line
treatment for patients with Stage IV non-small cell lung cancer
(NSCLC) in the randomized, double-blind Phase 3 GEMSTONE-302 study.
These data were reported after a planned interim analysis for OS, a
key secondary endpoint of the study. These results build on
previously presented positive data from the GEMSTONE-302 study,
which met the primary endpoint of progression-free survival (PFS)
and were recently published in The Lancet Oncology.1
Clinical benefit was observed across subgroups, including
patients with squamous and non-squamous subtypes, and regardless of
PD-L1 expression levels. As previously reported, the safety profile
of sugemalimab was consistent with that of the PD-1/PD-L1
class.1
“We are highly encouraged to see that sugemalimab in combination
with chemotherapy demonstrates significant clinical benefit,
including improvement in both PFS and OS, when compared to placebo
plus chemotherapy across a broad spectrum of patients with Stage IV
non-small cell lung cancer in this Phase 3 study,” said Vince
Miller, MD, physician-in-chief at EQRx. “Price remains a barrier to
accessing innovative therapies for many people with lung cancer
around the world, despite the availability of multiple anti-PD-(L)1
therapies. We look forward to engaging with global regulatory
authorities with the aim of delivering a lower-cost treatment
option to patients upon approval.”
Detailed results will be submitted for presentation at a future
medical congress.
In addition to the ongoing GEMSTONE-302 study, the companies are
investigating sugemalimab as a consolidation therapy in patients
with locally advanced, unresectable Stage III NSCLC without disease
progression after either concurrent or sequential chemoradiotherapy
in the pivotal Phase 3 GEMSTONE-301 study. Positive PFS data from
GEMSTONE-301 were also presented at ESMO 2021 and recently
published in The Lancet Oncology.2,3,4
About Lung CancerEvery 15 seconds, a person
across the world is diagnosed with lung cancer, and every 18
seconds, a person dies of the disease, making it the second most
commonly diagnosed cancer and leading cause of cancer deaths
worldwide. In 2020, an estimated 2.2 million people were diagnosed
with lung cancer.5 NSCLC is the most common type of lung cancer,
accounting for 84% of all lung cancer diagnoses.6
About GEMSTONE-302GEMSTONE-302 (NCT03789604) is
a randomized, double-blind, Phase 3 study designed to evaluate the
efficacy and safety of sugemalimab or placebo in combination with
carboplatin-based chemotherapy as a first-line treatment in
patients with Stage IV squamous or non-squamous NSCLC. The study
was conducted in China by CStone Pharmaceuticals and included 479
patients, who were randomized to either the sugemalimab group
(n=320) or the placebo group (n=159). The primary endpoint was
investigator-assessed PFS. Secondary endpoints include blinded
independent central review (BICR)-assessed PFS, safety and OS.
CStone Pharmaceuticals previously shared positive results of the
final analysis of PFS, the primary endpoint of the study, from
GEMSTONE-302 at the IASLC 2021 World Conference on Lung Cancer and
results were recently published in The Lancet Oncology.7,8
About SugemalimabSugemalimab is an
investigational monoclonal antibody targeting programmed
death-ligand 1 (PD-L1) discovered by CStone Pharmaceuticals.
Authorized by the U.S.-based Ligand Corporation, sugemalimab is
developed by the OmniRat® transgenic animal platform, which can
generate fully human antibodies in one stop. Currently, sugemalimab
is being investigated in a number of ongoing clinical trials
including one Phase 2 registration study in relapsed/refractory
extranodal natural killer (NK)/T cell lymphoma (ENKTL) and four
Phase 3 registration studies in Stage III NSCLC (GEMSTONE-301),
Stage IV NSCLC (GEMSTONE-302), gastric cancer and esophageal
cancer. Both the GEMSTONE-301 and GEMSTONE-302 studies met their
primary endpoints of prolonged PFS, and results were recently
presented at global medical congresses. In December 2021, the
National Medical Products Administration (NMPA) of China approved
the New Drug Application (NDA) for sugemalimab combined with
chemotherapy for the first-line treatment of metastatic squamous
and non-squamous NSCLC patients. In September 2021, the NDA for
Stage III NSCLC was accepted by the NMPA. EQRx holds the
development and commercialization rights to sugemalimab outside of
Greater China. EQRx and CStone Pharmaceuticals have partnered to
expand global access to sugemalimab, with plans to continue
regulatory discussions in multiple countries.
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 providers. 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, Inc.
Cautionary Statement Regarding Forward-Looking
Statements
This 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,” “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 EQRx’s ability to develop
and deliver innovative medicines at radically lower prices, EQRx’s
ability to expand its pipeline, plans and timelines for the
clinical development of EQRx’s product candidates, including the
therapeutic potential, clinical benefits and tolerability thereof,
expectations regarding EQRx’s existing collaboration with CStone
Pharmaceuticals, as well as other statements regarding plans and
market opportunities of EQRx. 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 changes in the competitive and highly regulated
industries in which EQRx operates, variations in operating
performance across competitors, changes in laws and regulations
affecting EQRx’s business, delay of any current and future clinical
trials or the development of sugemalimab or EQRx’s other drug
candidates, the risk that the results of prior clinical trials may
not be predictive of future results in connection with future
clinical trials, EQRx’s ability to successfully demonstrate the
safety and efficacy of its drug candidates, the timing and outcome
of EQRx’s planned interactions with regulatory authorities;
obtaining, maintaining and protecting its intellectual property,
EQRx’s relationships with CStone Pharmaceuticals and its other
existing and future collaboration partners, risks associated with
EQRx’s ability to otherwise implement its business plans, including
risks associated with its growth strategy, obtaining regulatory
approvals, and creating a global payer network, and other risks
associated with its plans to create a new kind of pharmaceutical
company, the risk of downturns and a changing regulatory landscape
in the highly competitive healthcare and biopharmaceutical
industries, the size and growth of the markets in which EQRx
operates and its ability to offer innovative medicines at reduced
prices, and EQRx’s ability to operate as a public company. 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 of the
prospectus dated December 23, 2021 and filed with the SEC under
Rule 424(b) and other documents filed by EQRx from time to time
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.
EQRx Contacts:
Media:Dan Budwick1ABdan@1abmedia.com
Investors:investors@eqrx.com
References________________________________
1 Zhou C, Wang Z, Sun Y, et al. Sugemalimab versus placebo, in
combination with platinum-based chemotherapy, as first-line
treatment of metastatic non-small-cell lung cancer (GEMSTONE-302):
an interim and final analyses of a double-blind, randomised, phase
3 clinical trial. The Lancet Oncology. Published January 14, 2022.
DOI: https://doi.org/10.1016/S1470-2045(21)00650-1.2 EQRx Announces
Presentation of Phase 3 Data Demonstrating a Progression-Free
Survival Benefit with Sugemalimab Consolidation Therapy in Patients
with Stage III NSCLC at ESMO Congress 2021. Press Release.
September 17, 2021. Available here:
https://www.eqrx.com/press-release/eqrx-announces-presentation-of-phase-3-data-demonstrating-a-progression-free-survival-benefit-with-sugemalimab-consolidation-therapy-in-patients-with-stage-iii-nsclc-at-esmo-congress-2021/3
Wu Y, Zhou Q, Chen M, et al. LBA43 - GEMSTONE-301: A randomized,
double-blind, placebo-controlled, phase III study of sugemalimab in
patients with unresectable stage III non-small cell lung cancer
(NSCLC) who had not progressed after concurrent or sequential
chemoradiotherapy (CRT). ESMO 2021. Annals of Oncology (2021) 32
(suppl_5): S1283-S1346. 10.1016/annonc/annonc741.4 Zhou Q, Chen M,
Jiang O, et al. Sugemalimab versus placebo after concurrent or
sequential chemoradiotherapy in patients with locally advanced,
unresectable, stage III non-small-cell lung cancer in China
(GEMSTONE-301): interim analysis of a randomised, double-blind,
multicentre, phase 3 trial. The Lancet Oncology. Published January
14, 2022. DOI: https://doi.org/10.1016/S1470-2045(21)00630-6.5
World Health Organization, International Agency for Research on
Cancer. Globocan 2020: Lung Cancer. International Agency for
Research on Cancer. Available here:
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed January 18, 2022.6 American Cancer Society, Key Statistics
for Lung Cancer. Available here:
https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html.
Accessed January 18, 2022.7 EQRx Announces Presentation of Updated
Data from Pivotal Phase 3 Study of Anti-PD-L1 Antibody Sugemalimab
in Combination with Chemotherapy as a First-Line Treatment for
Stage IV NSCLC. Press Release. September 13, 2021. Available here:
https://www.eqrx.com/press-release/eqrx-announces-presentation-of-updated-data-from-pivotal-phase-3-study-of-anti-pd-l1-antibody-sugemalimab-in-combination-with-chemotherapy-as-a-first-line-treatment-for-stage-iv-nsclc/8
Zhou C, Wang Z, Sun Y, et al. GEMSTONE-302: Randomized,
Double-Blind, Phase 3 Study of Sugemalimab or Placebo Plus
Platinum-Based Chemotherapy as First-Line Treatment for Metastatic
NSCLC. IASLC 2021 World Conference on Lung Cancer. MA13.07 Mon Sept
13. DOI: https://doi.org/10.1016/j.jtho.2021.08.180.
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