Australian-led international clinical trial demonstrates improved survival with new treatment for patients with advanced gastro-oesophageal cancer

The international clinical trial, INTEGRATE IIa, has demonstrated improved survival with a new treatment for patients with advanced gastro-oesophageal cancer (AGOC).

The results were presented today at the 2023 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.

The INTEGRATE IIa study, a phase III trial evaluating regorafenib for the treatment of patients with advanced gastro-oesophageal cancer (AGOC), has met its primary endpoint of a statistically significant improvement in overall survival of about 30%.

The study randomised 251 patients from 40 recruiting sites across six countries worldwide, including North America and Asia.

Regorafenib is the first oral multi-targeted tyrosine kinase inhibitor (TKI) to demonstrate improved overall survival in a mixed population of Asian and non-Asian patients with metastatic or locally recurrent gastro-oesophageal cancer.

This international trial was led by the Australasian Gastro-Intestinal Trials Group (AGITG) and conducted by the NHMRC Clinical Trials Centre (NHMRC CTC).

Gastric cancer is currently the fifth most common cancer, and the fourth most common cause of cancer-related deaths worldwide. For AGOC there remains a poor prognosis, with chemotherapy or biologic therapy in the refractory setting associated with a median overall survival of less than six months and real-world data in stage IV disease associated with a 2-year overall survival of less than 10%.

The AGITG is leading a study currently conducted by the NHMRC CTC, a multinational phase III study called INTEGRATE IIb, which is further investigating the combination of regorafenib and nivolumab, compared to standard chemotherapy alone.

Regorafenib is a compound developed by Bayer which provided drug and funding for the trial. The study was conducted independently of Bayer.