Pfizer's Cejemly® Becomes World’s First PD-L1 Inhibitor Approved for Relapsed/Refractory Extranodal NK/T-cell Lymphoma

Zejel® is the world's first PD-L1 monoclonal antibody to receive conditional approval for the treatment of adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL).

The approval of Zhejie Stone® will change the current landscape where there is no standard treatment for relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL).

On October 30, 2023, Pfizer announced that the third indication of its innovative oncology immunotherapy Zhejie Stone® (generic name: Sugemalimab Injection) has been granted conditional approval by the National Medical Products Administration (NMPA) for monotherapy to treat adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). This approval is based on the results of the GEMSTONE-201 study, which aimed to evaluate the efficacy and safety of Zhejie Stone® as a monotherapy for adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). As the world’s first PD-L1 antibody approved for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL), Zhejie Stone® will address the current clinical challenge where no standard treatment options are available in this field. Since the end of 2021, Zhejie Stone® has already received two approvals in China for indications within the non-small cell lung cancer field.

Jean-Christophe Pointeau, President of Pfizer China, Chairman of the RDPAC Executive Committee, and Vice President of the China Association of Enterprises with Foreign Investment, stated:"The field of oncology has always been a strategic focus for Pfizer. We deeply understand that for cancer patients, time is life. With the mission of 'bringing breakthrough innovations that change patients' lives,' Pfizer is committed to accelerating innovation exploration, filling clinical gaps, and promoting the continuous development of diagnosis and treatment for common and highly prevalent tumor types in China. The conditional approval of the new indication for Zejia® brings new hope to patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). In the future, Pfizer will continue to uphold the concept of 'science wins, overcoming cancer together,' delve into the field of hematological tumor treatment, transform patient treatment patterns, improve overall survival rates and quality of life, and contribute to the realization of the 'Healthy China 2030' goals."

Lymphoma is a common malignant tumor in China, with about 101,500 new cases and 47,000 deaths annually. Extranodal NK/T-cell lymphoma (ENKTL) is a subtype of mature T-cell and NK-cell lymphomas, and its incidence rate in Asian populations is significantly higher than in Europe and North America. In China, the incidence of extranodal NK/T-cell lymphoma (ENKTL) accounts for approximately 6% of all lymphoma subtypes and 28% of mature T-cell and NK-cell lymphomas. After chemotherapy regimens based on L-asparaginase became the mainstream first-line treatment for ENKTL, clinical outcomes improved to some extent. However, about 50% of patients will progress to refractory or relapsed stages within five years. The median survival time for patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL) is only around six months, and the one-year survival rate is usually less than 20%. Currently, there is no standard treatment regimen for these patients.

Principal investigator of the GEMSTONE-201 study, Professor Huang Huiqiang from the Sun Yat-sen University Cancer Center, stated: "The GEMSTONE-201 study is, to date, the largest registrational clinical trial of a PD-L1 monoclonal antibody for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). The primary endpoint results indicate that Cejiaomei® will transform the current treatment landscape for patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL), offering them a standard treatment option. We also look forward to this drug being rapidly introduced into clinical practice to help more patients gain access to a new treatment alternative."

About Zhejie® (Sugemalimab Injection)

Zejia Mei® is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals, based on the OmniRat® transgenic animal platform licensed from Ligand Corporation in the United States. As a fully human full-length anti-PD-L1 monoclonal antibody, Zejia Mei® is a monoclonal antibody drug close to natural immunoglobulin G4 (IgG4) in humans, with a lower risk of immunogenicity and related toxicity, giving Zejia Mei® unique advantages over similar drugs. Furthermore, the retention of antibody-dependent cellular phagocytosis (ADCP) allows Zejia Mei® to act on both innate immunity and adaptive immunity, offering unique dual-mechanism benefits. In Phase Ia and Ib studies, Zejia Mei® demonstrated favorable anti-tumor activity and tolerability across multiple cancer types. Based on early clinical data, Zejia Mei® is actively advancing clinical research in China and internationally.

In December 2021, the National Medical Products Administration (NMPA) approved Zhejie Stone® in combination with chemotherapy for first-line treatment of patients with metastatic stage IV driver gene-negative non-small cell lung cancer (NSCLC). In May 2022, a new indication for Zhejie Stone® was approved for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who did not experience disease progression after receiving platinum-based concurrent or sequential chemoradiotherapy. In 2022, both the stage III and stage IV indications for Zhejie Stone® were included in the "CSCO Guidelines for the Diagnosis and Treatment of Primary Non-Small Cell Lung Cancer" (2022 edition). In October 2023, it was approved as a single agent for the treatment of adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/RENKTL). This indication received conditional approval based on the objective response rate and duration of response results from a single-arm clinical trial. Confirmatory clinical endpoint data are not yet available and will require further validation post-marketing.

About Pfizer Oncology

At Pfizer Oncology, we are always committed to advancing the research of drugs that are of great significance to patients. Globally, Pfizer Oncology currently has 24 oncology drugs and biosimilars, which cover more than 30 indications, including breast cancer, lung cancer, urological cancers, hematological malignancies, gastrointestinal cancers, and melanoma.

References:
1. "Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines (2023 Edition)"
2. Li Xiaoqiu, et al. "Subtype Distribution of Lymphoma in China: An Analysis of 10,002 Cases from Multiple Centers in China." Journal of Diagnostics Theory and Practice 11.2 (2012): 5.
3.LimSH,HongJY,LimST,etal.AnnOncol2017;28:2199-205.
4.BelleiM,etal.Haematologica2018;103(7):1191-7.

Editor: Baiji

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