- EMA CHMP recommendation is based on the results of a Phase 3
clinical trial (GEMSTONE-302) demonstrating significant
progression-free survival (PFS) and overall survival (OS) benefits
of sugemalimab in combination with chemotherapy as a first-line
treatment for non-small cell lung cancer (NSCLC).
- Sugemalimab is expected to become the first anti-PD-L1
monoclonal antibody (mAb) in the world approved in Europe for both first-line squamous and
non-squamous NSCLC, regardless of PD-L1 expression, potentially
also the first domestic anti-PD-L1 mAb marketed in ex-China regions.
- In addition to the recent partnership with Ewopharma in Central
Eastern Europe and Switzerland,
multiple potential partners in other countries or regions are in
deep conversations with CStone for sugemalimab.
SUZHOU, China, June 1, 2024
/PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an
innovation-driven biopharmaceutical company focused on the research
and development of anti-cancer therapies, today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a positive opinion
recommending approval of sugemalimab in combination with
chemotherapy as a first-line treatment for metastatic non-small
cell lung cancer (NSCLC), which is one of the largest cancer
indications and a leading cause of cancer death in the world.
Sugemalimab is expected to become the first anti-PD-L1 monoclonal
antibody (mAb) approved in Europe
for both first-line squamous and non-squamous NSCLC, regardless of
PD-L1 expression, also making CStone the very first
biopharmaceutical company in China
to potentially launch a domestic anti-PD-L1 mAb in ex-China markets.
Dr. Jason Yang, CEO, President of
R&D, and Executive Director at CStone, said, "The positive
opinion from EMA CHMP normally indicates an upcoming approval
for market authorization by the European Commission, marking a
significant milestone not only for sugemalimab but also for CStone
and the entire pharmaceutical industry in China. The CHMP recommendation brings us
closer to delivering this innovative treatment to European patients
with lung cancer, and it also highlights a major milestone in
CStone's global strategy. Stage IV NSCLC is the first of several
other indications where sugemalimab has been shown to bring
significant benefits and we are planning to file for registration
in these other important indications including stage III NSCLC,
gastric cancer, esophageal cancer, etc. In addition, we have been
actively engaging in substantive discussions with numerous other
potential partners in various countries or regions to follow our
recently announced strategic commercial collaboration with
Ewopharma in Central Eastern Europe and Switzerland. We are confident and eagerly
anticipate collaborating to swiftly propel sugemalimab into broader
global markets and benefiting more patients across multiple
indications. I would also like to thank the CStone team for their
hard work and persistence over the years to achieve this important
milestone."
CHMP recommendation is primarily based on the results of
GEMSTONE-302, a multi-center, randomized, double-blind, Phase 3
clinical trial. Sugemalimab in combination with chemotherapy
significantly improved PFS and OS compared to placebo in
combination with chemotherapy in previously untreated stage IV
NSCLC patients. The study results have been published in The
Lancet Oncology and Nature Cancer and reported in oral
sessions at various international academic conferences.
Sugemalimab is an anti-PD-L1 monoclonal antibody developed by
CStone, which has been approved in China for five indications, including stage
III and IV NSCLC, extranodal NK/T-cell lymphoma, esophageal
squamous cell carcinoma, and gastric cancer. Additionally, the U.K.
Medicines and Healthcare products Regulatory Agency (MHRA) is
currently reviewing the marketing authorization application for
sugemalimab combined with chemotherapy as a first-line treatment
for metastatic NSCLC. The company is also in communications with
regulatory authorities such as the EMA, MHRA, and U.S. Food and
Drug Administration (FDA) regarding additional indications for
sugemalimab and is actively seeking development and
commercialization partnerships in other countries and regions
worldwide.
About Lung Cancer
In 2020, lung cancer was the third
most diagnosed cancer in Europe
and the leading cause of cancer-related mortality, accounting for
one fifth of cancer deaths.i Approximately fifty to
seventy percent of lung cancer cases in Europe are diagnosed in Stage IVii
Globally, it is estimated that NSCLC accounts for approximately 85%
of all lung cancers.iii
About Sugemalimab
The anti-PD-L1 monoclonal
antibody sugemalimab was developed by CStone using
OmniRat® transgenic animal platform, which allows
creation of fully human antibodies in one step. Sugemalimab is a
fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4)
monoclonal antibody, which may reduce the risk of immunogenicity
and toxicity for patients, a unique advantage over similar drugs.
Sugemalimab's unique molecular design enables a dual mechanism of
action that not only blocks PD-1/PD-L1 interaction, but also
induces antibody dependent cellular phagocytosis (ADCP) by
cross-linking PD-L1 expressing tumor cells with tumor associated
macrophages (TAMs) without harming Effector T-cells. This
differentiation has resulted in potentially best-in-class
efficacy/safety across a variety of tumor types.
The National Medical Products Administration (NMPA) of
China has approved sugemalimab for
five indications:
- In combination with chemotherapy as first-line treatment of
patients with metastatic squamous and non-squamous NSCLC;
- For the treatment of patients with unresectable Stage III
NSCLC whose disease has not progressed following concurrent or
sequential platinum-based chemoradiotherapy;
- For the treatment of patients with relapsed or refractory
extranodal NK/T-cell lymphoma;
- In combination with fluorouracil and platinum-based
chemotherapy as first-line treatment of patients with unresectable
locally advanced, recurrent or metastatic ESCC; and
- In combination with fluoropyrimidine- and platinum-containing
chemotherapy as first-line treatment for unresectable locally
advanced or metastatic gastric or gastroesophageal junction (G/GEJ)
adenocarcinoma with a PD-L1 expression (Combined Positive Score
[CPS] ≥5).
In addition to the EMA, the UK MHRA has also accepted the MAA
for sugemalimab in combination with chemotherapy as first-line
treatment for metastatic NSCLC. The application is currently under
review.
About CStone
CStone (HKEX: 2616), established in late 2015, is an
innovation-driven biopharmaceutical company focused on the research
and development of anti-cancer therapies. Dedicated to addressing
patient's unmet medical needs in China and globally, the company has made
significant strides since its inception. To date, the company has
successfully launched four innovative drugs and secured approvals
for 14 new drug applications (NDAs) covering 9 indications. The
company's pipeline is balanced by 12 promising candidates,
featuring potentially first-in-class or best-in-class antibody-drug
conjugates (ADCs), multispecific antibodies, immunotherapies and
precision medicines. CStone also prides itself on a management team
with comprehensive experiences and capabilities that span the
entire drug development spectrum, from preclinical and
translational research to clinical development, drug manufacturing,
business development, and commercialization.
For more information about CStone, please visit
www.cstonepharma.com.
Forward-looking statements
The forward-looking
statements made in this article only relate to events or
information as of the date when the statements are made in this
article. Except as required by law, we undertake no obligation to
update or publicly revise any forward-looking statements, whether
as a result of new information, future events or otherwise, after
the date on which the statements are made or to reflect the
occurrence of unanticipated events. You should read this article
completely and with the understanding that our actual future
results or performance may be materially different from what we
expect. All statements in this article are made on the date of
publication of this article and may change due to future
developments.
i Dyba T, et al. The European cancer burden in 2020:
Incidence and mortality estimates for 40 countries and 25 major
cancers. Eur J Cancer. 2021;157:308-347.
ii van Meerbeeck, J. et al. Lung cancer
screening in Europe: where are we
in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.
iii Zhang, et al. The prevalence of EGFR mutation in
patients with non-small cell lung cancer: a systematic review and
meta-analysis. Oncotarget. 2016;7:78985-78993.
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