On Tuesday, Oct. 25, 2011, Bayer AG announced that it is ending its multi-national regorafenib Phase III clinical trial 14 months early due to the study’s promising interim results. In the study’s 18-month interim reports, regorafenib demonstrated statistically significant improvements in overall survival for patients with metastatic colorectal cancer (mCRC).
All of the patients registered for the study had metastatic Stage IV colorectal cancer that was unresponsive to all previous chemotherapies and ineligible for surgery. Bayer’s CORRECT Phase III clinical trial, identifier NCT01103323, studied overal patient survival by comparing two groups: a dosed group which received regorafenib and a control group which received a placebo pill. Patients in both arms of the trial also received Best Supportive Care (BSC), defined in this study as current available treatments and palliative care measures for symptom management.
In the double-blind comparative study, none of the 760 participants knew if they were receiving regorafenib or the placebo. When Bayer evaluated the interim study results, they decided to unblind the study and offer regorafenib to the patients in the control arm so that they could benefit from the drug’s promising effects on overall survival.
John Marshall, MD, chief of hematology/oncology at the Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC was quoted on October 25 in Medscape Medical News describing regorafenib as an “agent [that] represents a new class of drug for this disease, and we hope that further studies will prove that it has even greater value in earlier lines of therapy.”
Bayer AG press releases describe regorafenib as “an oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK) [which] inhibits angiogenic kinases like receptors for VEGF which play central roles in angiogenesis.” Regorafenib also has demonstrated inhibition of RAF, RET, KIT and PDGFR oncogenic kinases.
Because regorafenib showed antitumor and tumor growth inhibition activities in preclinical studies, Bayer AG is currently running and recruiting patients for clinical trials of regorafenib in patients with various tumor types, including non-small cell lung cancer, GIST, and first line mCRC in combination with approved cocktails like FolFOX and FolFIRI. The company is also recruiting trials to study regorafenib in metastatic colorectal cancer patients whose tumors are K-RAS or BRAF mutant and unresponsive to Erbitux and Vectibix.
The CORRECT study had enrolled patients in over 170 locations: 18 countries in North and South America, Europe, Asia and Australia, and in cancer centers in 17 U.S. states. Bayer is now pursuing approvals for regorafenib from the FDA and the European Medicines Agency. The 18-month interim results for Bayer’s Phase III trial should be presented at an upcoming scientific meeting prior to publication.
- Improved Survival in CRC; Regorafenib Study Halted, Medscape Today News
- Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy, Clinicaltrials.gov (Phase III, ended early)
- Phase III Trial of Regorafenib in Metastatic Colorectal Cancer Meets Primary Endpoint of Improving Overall Survival, 26 Oct 2011, Bayer AG news release (not intended for U.S./U.K. media)
- Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in K-RAS/BRAF Mutant Metastatic Colorectal Cancer, Clinicaltrials.gov (Phase II, recruiting)
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