Sintilimab Safe, Effective for Relapsed or Refractory Hodgkin’s Lymphoma Patients, Phase 2 Trial Shows

Sintilimab Safe, Effective for Relapsed or Refractory Hodgkin’s Lymphoma Patients, Phase 2 Trial Shows

Sintilimab (IBI308), an immunotherapy candidate, was found to be safe and completely eliminated tumors in one-fourth of Chinese patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL) treated in a Phase 2 trial.

Preliminary trial results were discussed in a recent presentation, “Sintilimab (IBI308) in relapsed/refractory classical Hodgkin lymphoma: A multicenter, single-arm phase 2 trial in China (ORIENT-1 study),” at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago.

“Sintilimab will bring new hope for patients with relapsed and refractory classical Hodgkin Lymphoma in China,” Michael Yu, Innovent’s founder and CEO, said in a press release. “Our mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Now we have just completed the very first critical step toward that mission.”

Sintilimab, being jointly developed by Innovent Biologics and Eli Lilly and Company in China, is a kind of immunotherapy called an immune checkpoint inhibitor. It blocks the binding of the PD-1 receptor in T-cells to PD-L1 in cancer cells — a mechanism used by tumors to evade immune attack.

The multicenter, open-label Phase 2 ORIENT-1 trial (NCT03114683) assessed sintilimab as a treatment for cHL patients who failed to respond to two or more prior therapies or whose tumor returned after an initial response.

A total of 96 patients received sintilimab every three weeks until disease worsening, death, unacceptable toxicity, or withdrawal from the study. Radiotherapy had been administered to 54.2% of patients.

The study’s primary goal was to determine the number of patients achieving either a complete response or a partial tumor reduction — a measure called the objective response rate. Sintilimab’s effects were evaluated by an independent committee.

After a median of nine treatment cycles and a minimum follow-up of 24 weeks, 79.2% of patients had responded to the treatment, including 24% whose tumor had completely disappeared.

Of significance, 97.9% of the participants achieved at least disease stabilization after receiving sintilimab.

At the time of the analysis, most patients were still responding to the therapy. The most frequent treatment-related adverse event was fever, which occurred 43.8% of patients, most cases of which were mild or moderate.

No unexpected safety issues or deaths were reported. Sintilimab’s safety profile was similar to other anti-PD-1 antibodies.

In April, the China Food and Drug Administration’s Center for Drug Evaluation accepted sintilimab’s new drug application for the treatment of relapsed or refractory cHL. It was subsequently granted priority review status.

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