Shanghai Henlius Biotech has announced that its anti-PD-1 monoclonal antibody Hansizhuang (serplulimab, known as Hetronifly in Europe) combined with chemotherapy, met the primary endpoint in a Phase III trial for gastric cancer.
An interim analysis of the ASTRUM-006 trial showed that the treatment met the endpoint of event-free survival (EFS) for neoadjuvant/adjuvant treatment of gastric cancer.
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This means it is the first regimen globally to substitute adjuvant chemotherapy with mono-immunotherapy in perioperative gastric cancer treatment.
ASTRUM-006 is a multi-centre, double-blind, randomised Phase III trial involving participants with early-stage gastric cancer.
It is designed to compare the safety and efficacy of Hansizhuang or a placebo in conjunction with chemotherapy, serving as neoadjuvant/adjuvant monotherapy.
The interim analysis performed by the Independent Data Monitoring Committee (IDMC) confirmed that the trial has met its predefined efficacy criteria.
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By GlobalDataIn comparison to the placebo along with chemotherapy, the Hansizhuang and chemotherapy combo extended EFS and achieved a pathological complete response rate.
This rate was observed to be more than three-times greater than that of the control group, significantly reducing the risk of recurrence.
The combination regimen also exhibited a favourable safety profile and no new safety signals were identified.
The IDMC has recommended the early submission of a New Drug Application.
Henlius CEO and executive director Dr Jason Zhu said: “Gastrointestinal cancer is a core therapeutic area of dedicated focus for Henlius. The successful achievement of the primary endpoint in the Phase III perioperative study of Hansizhuang in gastric cancer marks a pivotal breakthrough for the company.
“We are committed to actively advancing the translation of these findings into clinical practice, with the goal of bringing benefits to patients at the earliest opportunity. Concurrently, we will continue to accelerate the in-depth exploration and broad application of more innovative therapies.”
