World’s First Perioperative Immunization Phase III Study Results in Esophageal Cancer Presented at 2024 ASCO GI

January 23, 2024  Source: drugdu 45

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The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) was held in San Francisco from January 18 to 20, local time. As an academic event in the field of gastrointestinal tumors, ASCO GI showcased several heavyweight and innovative scientific advances in the field, especially the release of the Late-breaking Abstract (LBA) study, which will lead the way to a new direction in clinical treatment.

Phase III study (ESCORT-NEO/NCCES01), led by Prof. Li Yin of Cancer Hospital, Chinese Academy of Medical Sciences, with the participation of 24 centers across China, was selected as LBA. Professor Li Yin reported the results of the study, which is the world's first perioperative immunization Phase III study in esophageal cancer. Neoadjuvant carelizumab in combination with chemotherapy showed a significantly better pCR rate than that of neoadjuvant chemotherapy, achieving the primary endpoint without increasing the risk of surgery and with a manageable safety profile. This result signifies that carelizumab combination chemotherapy is expected to become a potential standard treatment option for resectable locally advanced ESCC, which will bring new hope to more ESCC patients, and at the same time promote the perioperative treatment of esophageal cancer into a new era of immunotherapy.

As the seventh most common malignant tumor in the world, esophageal cancer in China accounts for more than 50% of the global morbidity and mortality, and more than 50% of ESCC is in locally advanced stage at the time of diagnosis, and its standard treatment mode is the comprehensive treatment based on neoadjuvant (radiotherapy) chemotherapy combined with surgery. With the advancement of surgical technology and the wide application of perioperative treatment, the treatment effect of esophageal cancer in China has been significantly improved, but the 5-year survival rate of patients with locally advanced stage is still unsatisfactory.

In recent years, immunotherapeutic drugs represented by Hengrui Pharmaceuticals' innovative drug Karelizumab have been shown to have good efficacy in the treatment of a variety of solid tumors by virtue of the mechanism of action different from that of traditional anti-tumor therapy, establishing the standard status of immune-combination chemotherapy in the first-line treatment of advanced esophageal cancer, and significantly improving the survival of patients. Therefore, the medical community has high expectations for its exploration in the field of perioperative treatment of esophageal cancer, hoping that it can break through the bottleneck of the traditional perioperative treatment mode.

Neoadjuvant immunotherapy for locally advanced esophageal cancer is currently one of the hot areas in clinical research of esophageal cancer. Several phase II studies of neoadjuvant immunotherapy combined with chemotherapy for resectable locally advanced ESCC, represented by the NICE study, have obtained pCR rates of 20-40% with tolerable safety. Based on the results of several previous phase II studies, this phase III clinical trial (ESCORT-NEO/NCCES01) further evaluated the efficacy and safety of karelizumab in combination with chemotherapy versus chemotherapy alone in the perioperative treatment of esophageal cancer.

The ESCORT-NEO/NCCES01 study unveiled the pivotal endpoints of the world's first Phase III study of perioperative immune-combination chemotherapy for ESCC. Its results demonstrated that neoadjuvant karelizumab combination chemotherapy had a significantly better pCR rate than neoadjuvant chemotherapy, meeting the primary study endpoint. The therapy was safe and effective and did not negatively impact patients' subsequent surgeries. Based on the above strong evidence, perioperative carelizumab combination chemotherapy is expected to become a potential standard therapy for resectable locally advanced ESCC.

 

Source: https://mp.weixin.qq.com/s/zkvGe1wSH73n67qSTNj-XQ

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