CStone Pharmaceuticals’ sugemalimab (Cejemly) has been approved by the China National Medical Products Administration (NMPA) for the treatment of relapsed or refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL) in October 2023. With this approval, sugemalimab becomes the first anti-PD-1/PD-L1 monoclonal antibody approved for r/r ENKTL globally and is expected to boost CStone’s presence in the oncology market in China, says GlobalData, a leading data and analytics company.

The approval was based on a Phase II clinical trial as second-line therapy after prior asparaginase-based chemotherapy or chemo-radiotherapy for the treatment of adult patients with r/r ENKTL. The results showed that sugemalimab significantly improved the objective response rate (ORR) compared to historical controls.

Among the 78 patients with evaluable efficacy, the ORR assessed by the Independent Radiology Review Committee (IRRC) was 44.9%, with a complete response (CR) rate of 35.9%. Sugemalimab also demonstrated a well-tolerated safety profile in patients with r/r ENKTL, and no new safety signals were observed.

Nelluri Geetha, Pharma Analyst at GlobalData, comments: “Sugemalimab is the first PD-L1 therapy to be approved for r/r ENKTL globally. ENKTL patients often develop disease progression after receiving standard asparaginase-based regimens. As the current treatment approach for ENKTL in China is heavily based on asparaginase-based regimens, which are effective only as first-line treatment, there is a significant need to identify novel treatment targets for patients who have failed the first-line therapies.

“There have also been observed hematologic and non-hematologic treatment-related toxicities during first-line therapy with asparaginase-based regimens. However, sugemalimab demonstrated a well-tolerated safety profile in patients with r/r ENKTL, and no new safety signals were observed.”

According to GlobalData’s Pharmaceutical Intelligence Center, the other PD-1/PD-L1 inhibitor trials for ENKTL in China include Phase II studies of sintilimab (Innovent Biologics), tislelizumab (BeiGene Ltd), Phase I/IIA studies for IBC-0966 (Sunho Biopharmaceutical), HX-009 (Wuhan Hanxiong Biotechnology) and Phase I studies for KN-046 (Alphamab Oncology), AN4005 (Adlai Nortye Biopharma), geptanolimab (Genor BioPharma) and tagitanlimab (Sichuan Kelun Pharmaceutical Co Ltd).

GlobalData forecasts sugemalimab to generate sales of $31 million (patient-based forecast) by 2030 for T-cell lymphomas in China.

Geetha concludes: “With this approval, it is the second indication for sugemalimab to receive approval in China. Sugemalimab is already approved for stage III and IV non-small cell lung cancer (NSCLC). It is the second drug to get approval for ENKTL following Elzonris (tagraxofusp) approval in the US and Europe. Moreover, sugemalimab is the fifth drug from CStone in the Chinese oncology market and might reinforce CStone’s outlook with this approval, for which there is no standard established treatment yet.”