Sugemalimab Study Achieves Primary Endpoint for Refractory Extranodal Natural Killer/T-Cell Lymphoma and Progresses with China NMPA

Sugemalimab showed promise in the Phase 2 GEMSTONE-201 trial in a group of patients with extranodal natural killer/T-cell lymphoma; Developer CStone is set to submit a new drug application for the treatment to the National Medical Products Administration of China.

Sugemalimab has shown promising responses in a patient population with extranodal natural killer/T-cell lymphoma (ENKTL), according to results from the Phase 2 GEMSTONE-201 trial (NCT03595657) announced in a press release. developer CStone Pharmaceuticals press.

CStone plans to submit a new drug application for sugemalimab to the National Medical Products Administration (NMPA) of China in the short term for the treatment of patients with relapsed/refractory ENKTL. The main results of the study are expected to be read at an upcoming international academic conference.

Study results indicated that patients treated with sugemalimab showed significantly improved overall responses when assessed by an independent radiological review board compared to historical controls. Additionally, the investigator-assessed overall response rate appeared to be consistent with these findings.

“[Relapsed/refractory] ENKTL is highly cunning and aggressive. For a long time, there was no clinically effective therapeutic drug, which resulted in a low cure rate and poor prognosis. The success of the GEMSTONE-201 study demonstrated that sugemalimab could become a new treatment option for patients with [relapsed/refractory] ENKTL to address the extremely urgent medical needs of this patient population,” said lead researcher Huiqiang Huang, MD, PhD, professor of oncology at Sun Yatsen University Cancer Center in Guangzhou, China, in a press release.

China’s NMPA has already granted a new drug application for sugemalimab in combination with chemotherapy for the treatment of patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Another New Drug Application for the agent in NSCLC Stage III is also under regulatory review. As such, sugemalimab could be a new treatment option for patients with stage III or IV disease.

In the United States, sugemalimab was granted Orphan Drug Designation for the treatment of patients with T-cell lymphoma and Breakthrough Therapy Designation for ENKTL in 2020.

Reference

CStone announces that the Phase 2 GEMSTONE-201 trial met the primary endpoint of objective response rate (ORR) in patients with relapsed or refractory natural killer/extranodal T-cell lymphoma (R/ R ENKTL). Press release. CStone Pharmaceuticals. January 12, 2022. Accessed January 14, 2022. https://bit.ly/3rihUkc

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