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OUR IMPACT
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. Findings from Integrate IIa have shown that regorafenib can improve overall survival by about 30% in these patients.
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BACKGROUND |
Gastric cancer is currently the fifth most common cancer (5.6% of all new cases), and the fourth most common cause of cancer-related deaths worldwide (7.7% of all deaths). 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%. |
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STUDY OVERVIEW |
The Integrate IIa study followed the success of the Phase II INTEGRATE study, which demonstrated a positive signal with regorafenib. The purpose of INTEGRATE IIa was to see if Regorafenib improved overall survival as a third-line therapy in refractory AGOC. The primary objective is overall survival, while secondary objectives include progression free survival, objective response rates, safety, quality of life, and investigation in patient populations from different geographic regions. |
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PARTICIPANTS |
251 participants from 40 sites in Australia, Canada, Japan, Korea & Taiwan |
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EXPERTISE |
Conceived, designed and conducted in collaboration with AGITG Expertly designed methodology and endpoints incorporating the potential for prognostic biomarker review for AGOC patients. |
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FINDINGS |
INTEGRATE IIa demonstrated regorafenib significantly improved overall survival (OS) in patients with refractory advanced gastro-oesophageal carcinoma (AGOC) by around 30%. |
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DURATION |
2016 - 2022 |
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COLLABORATORS |
AGITG, Bayer |
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FURTHER READING |