EQRx, Inc. (Nasdaq: EQRX) a new type of pharmaceutical company
committed to developing and delivering important new medicines to
patients at radically lower prices, today announced that data from
its partner CStone Pharmaceuticals’ two pivotal Phase 3 studies of
the anti-PD-L1 monoclonal antibody sugemalimab for the treatment of
non-small cell lung cancer (NSCLC), GEMSTONE-301 and GEMSTONE-302,
were published in The Lancet Oncology. The publications were
accompanied by a comment article.
In GEMSTONE-301, sugemalimab resulted in a statistically
significant and clinically meaningful improvement in
progression-free survival (PFS) versus placebo when administered as
consolidation therapy in patients with locally advanced,
unresectable Stage III NSCLC without disease progression after
concurrent or sequential chemoradiotherapy. This represents the
first positive Phase 3 data for an anti-PD-L1 agent in this broader
population of patients with Stage III NSCLC.1
In GEMSTONE-302, the addition of sugemalimab to standard-of-care
chemotherapy as first-line systemic treatment provided a
statistically significant, clinically meaningful improvement in PFS
in patients with Stage IV NSCLC, regardless of PD-L1 expression
levels or pathologic subtype of NSCLC.2
“Taken together, the publication of data from these two Phase 3
studies in The Lancet Oncology adds to a growing body of evidence
suggesting that sugemalimab may be a promising option for a wide
range of patients with Stage III or Stage IV non-small cell lung
cancer upon approval in global regions beyond China,” said Vince
Miller, MD, physician-in-chief at EQRx. “We look forward to
progressing discussions with global regulatory authorities with the
goal of bringing a new, high-quality treatment option to these
patient populations at a much lower price.”
Results from GEMSTONE-301 reported in The Lancet Oncology are as
follows:
- Sugemalimab as consolidation therapy demonstrated a
statistically significant and clinically meaningful improvement in
PFS vs. placebo, as assessed by blinded independent central review
(BICR) at a prespecified interim analysis.
- Median PFS was 9.0 months vs. 5.8 months (Hazard Ratio
[HR]=0.64, p=0.0026).
- Clinical benefit was observed in patients who received either
concurrent or sequential chemoradiotherapy prior to treatment with
sugemalimab compared to placebo.
- For patients who received prior concurrent chemoradiotherapy
(cCRT), median PFS was 10.5 months vs. 6.4 months (HR=0.66).
- For patients who received prior sequential chemoradiotherapy
(sCRT), median PFS was 8.1 months vs. 4.1 months (HR=0.59).
- Overall survival (OS) data were immature at the time of the
analysis, but an encouraging trend for a survival benefit with
sugemalimab vs. placebo was observed, with follow-up of patients
ongoing.
- Sugemalimab was generally well-tolerated, with no new safety
signals observed.
- In the sugemalimab group, 9% of patients (n=22/255) experienced
grade 3 or 4 treatment-emergent adverse events (TEAEs) related to
study treatment.
- In the placebo group, 6% (7/126) experienced grade 3 or 4 TEAEs
related to study treatment.
Results of the final PFS analysis from GEMSTONE-302, also
reported in The Lancet Oncology, are as follows:
- Sugemalimab plus platinum-based chemotherapy significantly
prolonged PFS (median 9.0 vs 4.9 months; HR=0.48; p<0.0001)
compared with placebo plus platinum-based chemotherapy.
- OS data were immature at the time of the final PFS analysis,
but preliminary median OS was 22.8 months in the sugemalimab plus
chemotherapy arm compared to 17.7 months in the placebo plus
chemotherapy arm (HR=0.67).
- Clinical benefit was observed across all subgroups, regardless
of PD-L1 expression level or pathologic subtype of NSCLC.
- Sugemalimab was generally well-tolerated, with no new safety
signals observed.
- 53.8% of patients (172/320) in the sugemalimab group
and 56.0% (89/159) in the placebo group experienced
treatment-related grade 3 or 4 TEAEs, with the most common events
for both groups being neutrophil count decrease, white blood cell
count decrease, anemia, platelet count decrease and
neutropenia.
EQRx’s partner, CStone Pharmaceuticals, previously presented
results on the use of sugemalimab in the treatment of patients with
Stage III and Stage IV NSCLC at ESMO 20213,4 and the IASLC 2021
World Conference on Lung Cancer, respectively.5,6
Sugemalimab is being studied in patients with different stages
of NSCLC, in patients with gastric and esophageal cancers and in
patients with lymphoma.
About Lung Cancer
Every 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.7 NSCLC is the most common
type of lung cancer, accounting for 84% of all lung cancer
diagnoses.8
About GEMSTONE-301GEMSTONE-301 (NCT03728556) is
a randomized, double-blind, placebo-controlled Phase 3 study to
evaluate the efficacy and safety of sugemalimab as consolidation
therapy in patients with locally advanced, unresectable Stage III
NSCLC without disease progression after concurrent or sequential
chemoradiotherapy. The study was conducted in China by CStone
Pharmaceuticals and included 381 patients, who were randomized to
the sugemalimab group (n=255) or the placebo group (n=126). The
primary endpoint of the trial was progression-free survival (PFS)
as assessed by blinded independent central review (BICR) according
to RECIST v1.1. Secondary endpoints include OS and PFS as assessed
by the investigators and safety. In May 2021, EQRx and CStone
Pharmaceuticals announced that GEMSTONE-301 met its primary
endpoint of prolonged PFS.
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.9,10
About Sugemalimab
Sugemalimab 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 EQRx
EQRx 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 and EQRx’s ability to
maintain its existing license and other collaboration agreements,
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 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)00630-6.2 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. 3 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/.
Accessed January 14, 2021.4 Wu YL, 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): 32, S1321.
10.1016/annonc/annonc741.5 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/.
Accessed January 14, 2021.6 Zhou C, Wang Z, Sun Y, et al. MA13.07
GEMSTONE-302: A Phase 3 Study of Platinum-Based Chemotherapy with
Placebo or Sugemalimab, a PD-L1 mAb, for metastatic NSCLC. Journal
of Thoracic Oncology 2021; 16(10): S926-S7.
DOI:10.1016/j.jtho.2021.08.180. 7 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 14, 2021.8 American Cancer Society, Key Statistics
for Lung Cancer. Available here:
https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html.
Accessed January 14, 20219 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/10
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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