HANSIZHUANG’s Phase 3 Trial Achieves Key Milestone in Gastric Cancer Treatment Paving Way for Early NDA Submission

Overview of the Recent HANSIZHUANG Trial

The innovative anti-PD-1 monoclonal antibody HANSIZHUANG, also known as serplulimab (marketed as Hetronifly® in Europe), has made significant strides in the field of gastric cancer treatment. Recently, results from a Phase 3 clinical trial known as ASTRUM-006 revealed that the drug, when combined with chemotherapy, met its primary endpoint concerning Event-Free Survival (EFS). This pivotal achievement not only underlines the drug’s effectiveness but also positions it as a potential frontrunner for FDA approval, thus advancing towards an early New Drug Application (NDA) submission.

Significance of the ASTRUM-006 Study

The ASTRUM-006 trial represents a landmark in gastric cancer management, as it is the first study demonstrating the potential to replace conventional adjuvant chemotherapy with HANSIZHUANG as mono-immunotherapy for patients undergoing perioperative treatment. Conducted in a randomized, double-blind manner across multiple centers, the study involves early-stage gastric cancer patients who received either HANSIZHUANG combined with chemotherapy or a placebo with chemotherapy. The interim analysis performed by the Independent Data Monitoring Committee (IDMC) revealed compelling findings: a significant rise in EFS and a threefold increase in the rate of pathological complete response (pCR) in patients receiving the combination therapy compared to controls. Notably, these results were accompanied by a pronounced reduction in recurrence risk and a favorable safety profile, with no new adverse safety signals identified, bolstering the case for its broader application in clinical settings.

Expert Commentary

Prominent oncologists, such as Professor Jiafu Ji from Beijing Cancer Hospital, emphasized the importance of this breakthrough, stating that the study confirms the feasibility of utilizing mono-immunotherapy during the postoperative phase. This novel approach not only optimizes surgical outcomes but significantly reduces recurrence risks, heralding a new direction in clinical strategies. Similarly, Professor Lin Shen, also affiliated with Beijing Cancer Hospital, acknowledged the study's results affirming the potential of serplulimab to enhance patients' quality of life by offering a chemotherapy-free treatment option. Dr. Jason Zhu, CEO of Henlius, reiterated the company's commitment to addressing key oncology challenges, particularly in gastrointestinal (GI) cancers, emphasizing the need to translate these findings into practical benefits for patients at the earliest opportunity.

Understanding Gastric Cancer's Global Challenge

Gastric cancer remains a pressing global public health concern, with GLOBOCAN statistics from 2022 indicating approximately 969,000 new cases and around 660,000 deaths globally. Despite radical surgery being the cornerstone of gastric cancer treatment, optimizing perioperative strategies is vital for improving long-term survival outcomes. As the first-line standard for advanced gastric cancer transitions to immunotherapy plus chemotherapy, understanding its role during the perioperative phase has become increasingly critical.

Pioneering Monotherapy Approach with HANSIZHUANG

HANSIZHUANG operates through a unique mechanism that promotes rapid and potent immune activation while minimizing unwanted toxicity often associated with traditional chemotherapy. This ability to induce stronger PD-1 internalization effectively enhances T-cell activation and improves therapeutic efficacy without compromising safety. The innovative approach of employing HANSIZHUANG as a sole therapeutic agent in the adjuvant setting has set new standards, focusing on high efficacy with low toxicity, aiming to deliver enhanced patient experiences and outcomes.

Ongoing Commitment and Future Directions

As Henlius continues to broaden its reach in GI oncology, the success of the ASTRUM-006 trial marks a transformative moment in the management of gastric cancer. The company’s dedication to exploring further immunotherapy-based strategies, including the advanced research of other unique cancer treatments, showcases its commitment to bettering healthcare worldwide. Institutions remain optimistic about Henlius’s pipeline, which includes both established therapies and ground-breaking innovations designed to address high-incidence cancers effectively.

By leveraging comprehensive clinical data and insights, Henlius stands poised to solidify its position at the forefront of gastric cancer treatment, ultimately striving to meet unmet medical needs and elevate the standard of care for patients afflicted by this challenging disease.