CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
PR96349
SUZHOU, China, June 6, 2022 /PRNewswire=KYODO JBN/ --
* The National Medical Products Administration approved sugemalimab for the
treatment of patients with unresectable stage III non-small cell lung cancer
whose disease has not progressed following concurrent or sequential
platinum-based chemoradiotherapy
* Sugemalimab became the first anti-PD-1/PD-L1 monoclonal antibody approved for
stage III NSCLC following concurrent or sequential chemoradiotherapy. It's also
the only anti-PD-(L)1 monoclonal antibody approved for both stage III and stage
IV NSCLC
* This is the eighth approved new drug application (NDA) for CStone
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical
company focused on research, development, and commercialization of innovative
immuno-oncology therapies and precision medicines, and Pfizer Inc. (NYSE: PFE)
today announced that the National Medical Products Administration (NMPA) of
China has approved sugemalimab (Cejemly®) for the treatment of patients with
unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not
progressed following concurrent or sequential platinum-based chemoradiotherapy.
Together with the previous approval of the treatment for first-line stage IV
NSCLC patients, sugemalimab is now the only anti- PD-1/PD-L1 monoclonal
antibody for both stage III and stage IV NSCLC patients.
Dr. Frank Jiang, CEO of CStone, said, "We appreciate the NMPA for granting the
new approval which is an important milestone in our journey to lead the
treatment of lung cancer as China steps up efforts to support innovative
therapies and address unmet needs. As a leading biopharma company in fostering
precision medicines and immuno-oncology therapies, CStone has been spearheading
multiple medical breakthroughs. With this approval, it will provide a new
treatment option for stage III NSCLC patients, while demonstrating our prowess
in advancing lung cancer treatments and bringing forward transformative drugs
to the market. Partnerships are crucial to meet massive clinical needs of
cancer patients. We will continue to work closely with Pfizer to deliver
cutting-edge oncology therapies and improve the health of cancer patients in
China."
Jean-Christophe Pointeau, China President of Pfizer Biopharmaceutical Group,
says, "Committed to delivering 'breakthroughs that change patients' lives',
Pfizer has achieved a series of important breakthroughs in the field of
immuno-oncology. After the approval of Stage IV NSCLC indication a few months
ago, Cejemly® achieved immediate commercialization across China, offering hopes
to Chinese NSCLC patients with improved diagnosis and treatment solutions. We
firmly believe that the approval of the new indication will allow more patients
to benefit from this drug, bridge the gap and fulfill the unmet needs,
especially the needs of unresectable Stage III NSCLC patients for immune
consolidation therapy after sequential chemoradiotherapy. Cejemly® is Pfizer's
strategic asset in immuno-oncology, and a paradigm for innovative strategic
partnership with local biotech companies, like CStone guided by the slogan of
"Science Will Win, Conquer Cancer Together". Starting from here, Pfizer will
continue the exploration in this field, promote the upgrades and advances in
immunodiagnostics and immunotherapy, offer more tailor-made, globally
innovative solutions to Chinese cancer patients, and help to achieve the grand
goal of "Healthy China 2030".
Professor Yi-Long Wu of Guangdong Provincial People's Hospital, the Leading
Principal Investigator on the GEMSTONE-301 study, said, "Patients with stage
III NSCLC urgently need new treatment options, and the NMPA approval of
sugemalimab brings them hope. The results from GEMSTONE-301 demonstrated that
sugemalimab as a consolidation therapy had robust efficacy and a well-tolerated
safety profile. It is now recommended by the Chinese Society of Clinical
Oncology (CSCO) guidelines for this patient population. With proven clinical
benefits, sugemalimab will potentially reshape the treatment landscape as a
preferred immuno-oncology therapy for patients with mid- and late-stage lung
cancer."
Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are thrilled that
sugemalimab has become the first anti- PD-1/PD-L1 monoclonal antibody approved
for stage III NSCLC after concurrent or sequential chemoradiotherapy. The
GEMSTONE-301 study has an innovative study design that enrolled patients with
either concurrent or sequential chemoradiotherapy to better reflect real-world
clinical practice and cover a broad patient population. We've also made
significant progress in the registrational studies of sugemalimab in patients
with esophageal squamous cell carcinoma, gastric cancer, and relapsed or
refractory extranodal natural killer/T-cell lymphoma in a bid to benefit more
cancer patients."
The NMPA approval is based on the GEMSTONE-301 study, a multicenter,
randomized, double-blind phase 3 clinical trial, designed to evaluate the
efficacy and safety of sugemalimab as a consolidation therapy in patients with
unresectable stage III NSCLC without disease progression after concurrent or
sequential chemoradiotherapy. Sugemalimab significantly improved patients'
progression-free survival (PFS). The risk of disease progression or death was
reduced by 36%, together with encouraging overall survival (OS). Subgroup
analyses demonstrated clinical benefits regardless of whether patients received
prior concurrent or sequential chemoradiotherapy. Sugemalimab had a
well-tolerated safety profile, and no new safety signals were observed. The
results of the GEMSTONE-301 study were published in The Lancet Oncology in
January 2022.
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was discovered 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 allow a reduced risk of
immunogenicity and toxicity for patients, a unique advantage over similar drugs.
Currently, the NMPA of China has approved sugemalimab (Cejemly®) in combination
with pemetrexed and carboplatin as first-line treatment of patients with
metastatic non-squamous NSCLC, lacking epidermal growth factor receptor (EGFR)
and anaplastic lymphoma kinase (ALK) genomic tumor aberrations; and in
combination with paclitaxel and carboplatin as first-line treatment of patients
with metastatic squamous NSCLC; for the treatment of patients with unresectable
stage III NSCLC whose disease has not progressed following concurrent or
sequential platinum-based chemoradiotherapy.
With its proven therapeutic advantages, sugemalimab is set to be recommended by
the 2022 CSCO clinical guidelines for the diagnosis and treatment of NSCLC, in
combination with chemotherapy as the first-line treatment of patients with
stage IV non-squamous/squamous NSCLC without driver alterations; or as a
consolidation therapy in patients with stage III NSCLC after concurrent or
sequential chemoradiotherapy.
CStone formed a strategic collaboration agreement with Pfizer that includes the
development and commercialization of sugemalimab in mainland China, and a
framework to bring additional Oncology medicines to the Greater China market.
SOURCE: CStone Pharmaceuticals
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