Sugemalimab Study Meets Primary End Point for Refractory Extranodal Natural Killer/T-Cell Lymphoma, Moves Forward With NMPA of China

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 yielded promising responses in a population of patients with extranodal natural killer/T-cell lymphoma (ENKTL), according to findings from the phase 2 GEMSTONE-201 trial (NCT03595657) that were announced in a press release from developer CStone Pharmaceuticals.

CStone has plans to submit a new drug application for sugemalimab to the National Medical Products Administration (NMPA) of China in the near term for the treatment of patients with relapsed/refractory ENKTL. Topline findings from the study are set to read out at an upcoming international academic conference.

Findings from the study indicated that patients who were treated with sugemalimab experienced significantly enhanced overall responses when assessed by independent radiology review committee compared with historic controls. Moreover, the investigator-assessed overall response rate appeared to be consistent with these findings.

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

The NMPA of China has previous granted a new drug application to 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 stage III NSCLC is also under regulatory review. As such, sugemalimab could be new a treatment option for patients with either 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 phase 2 GEMSTONE-201 trial met primary endpoint of objective response rate (ORR) in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). News release. CStone Pharmaceuticals. January 12, 2022. Accessed January 14, 2022. https://bit.ly/3rihUkc