Chinese Biopharma Makes Potential Headway Against Unique Type of Non-Hodgkin Lymphoma

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

The epidemiology of the relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) is notoriously more rampant in Asia than in Europe or North America. R/R ENKTL is not only aggressive, malignant, and poorly prognostic, but is devoid of many possible treatment choices for the patients because of its rapid progression with extremely short overall survival rates of less than 20%. In other words, if patients with R/R ENKTL fail to respond to standard L-asparaginase-based regimens or traditional treatments, their lives hang on a thread. In China, the currently approved targeted monotherapy has a complete response rate of approximately 6%, which is far below the medical needs.

CStone Pharmaceutical, based in Suzhou, China, advanced a potential breakthrough treatment for R/R ENKTL when it announced on August 31st that the USFDA authorized an IND clearance for anti-PD-L1 monoclonal antibody Sugemalimab based on CS1001-201 Phase II clinical study. The IND clearance indicated the ongoing CS1001-201 trial in China would extend to the US. To bridge study in the US, the clinical program in China plans to include one multi-arm Phase Ib study for several tumor types, one Phase II registrational study for lymphoma, and four Phase III registrational studies.

CS1001-201 is a single-arm, multicenter clinical study that had a total of 32 patients with R/R ENKTL enrolled and had an objective response rate as the primary endpoint, which was assessed by an independent radiological review committee. All patients were administered 1200mg Sugemalimab intravenously every three weeks until the disease progressed or a toxicity intolerance was detected. Sugemalimab is analogous to the natural G-type immunoglobulin 4 (IgG4) human antibody, and thus reduces the risk of immunogenicity and potential toxicities in patients. Sugemalimab also showed good antitumor activity and good tolerability in multiple tumor types in a Phase I dose-escalation study in China.

According to Dr. Jason Yang, Chief Medical Officer of CStone, “data reported for CS1001-201 study on 2019 ASH meeting shows that Sugemalimab demonstrated a complete response rate of 33.3% with a durable response, an objective response rate (ORR) of 43.3%, and 1-year overall survival rate of 72.4%. These results represent a major breakthrough compared to current treatment options and support Sugemalimab as a potential conditioning regimen for hematopoietic stem cell transplantation.” Besides, the maximum duration of response was over 10.9 months, but the median duration of response was not reached.

Even if the median duration of response was not reached, no deaths due to adverse events occurred, but most participants experienced some adverse events. 93.8% reported treatment-emergent adverse events, while 75.0% reported treatment-related adverse events (9.4% of which had over Grade 3 treatment-related adverse events). Only 9.4% reported Grade 5 adverse events, and none were assessed as related to Sugemalimab. 14.6% reported immune-related adverse events, and 12.5% discontinued due to adverse events.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Novartis’ Kymriah Headed Towards Third Approval for Follicular Lymphoma




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