Dr Kim on the Rationale For Investigating the Use of Regorafenib in mCRC

Richard Kim, MD, service chief, Medical Gastrointestinal Oncology, senior member, Department of Gastrointestinal Oncology, Moffitt Cancer Center; professor, oncology, the University of South Florida College of Medicine, discusses the rationale for launching and the data derived from a real-world investigation of long-term responses with regorafenib (Stivarga) in patients with metastatic colorectal cancer (mCRC).

At the 2024 Gastrointestinal Cancers Symposium, Kim shared data from the investigation in a poster presentation. Investigators found that a positive ECOG performance status, lower baseline lactate dehydrogenase levels, and the absence of BRAF and KRAS mutations were among the characteristics linked to a prolonged response to regorafenib in patients with mCRC.

In 2012, regorafenib received FDA approval for use in the refractory setting for patients with mCRC who do not respond to standard lines of chemotherapy, based on findings from the phase 3 CORRECT trial (NCT01103323), Kim begins. The real-world analysis examined real-world evidence regarding the effectiveness of regorafenib in patients with mCRC and was motivated by case reports of some patients remaining on regorafenib for longer durations than reported in the CORRECT study, with instances of patients receiving regorafenib for 6 months, 8 months, and up to 24 months, Kim emphasizes.

The analysis further assessed how well patients responded to regorafenib in a real-world context, Kim continues Drawing data from the Flatiron Health database, investigators analyzed information on 849 patients who received regorafenib and had a long-term response to the agent, including baseline demographics, age, race, stage at diagnosis, and biomarkers, he elucidates. The primary end point was to evaluate long-term responders, defined as patients receiving regorafenib for at least 4 or 5 months, Kim notes.

Results indicate that 22% of the patients received regorafenib for more than 4 months, and 15% of patients received the agent for over 5 months, he expands, adding that biomarker analysis did not reveal any correlation between biomarkers and efficacy results. Similar to the CORRECT data, this real-world evidence indicates that a specific patient population can effectively receive regorafenib for more than 4 or 5 months, Kim concludes.