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Exelixis Announces Consistent Efficacy Benefits Across Subgroups of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-line Treatment for Patients with Advanced Renal Cell Carcinoma
– Efficacy benefits with recently approved combination regimen observed regardless of baseline International Metastatic Renal Cell Carcinoma Database
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Efficacy benefits with recently approved combination regimen observed regardless of baseline International Metastatic Renal Cell Carcinoma Database Consortium risk status, organ site of metastases or extent of tumor burden –\n\n– Data to be presented during the 2021 American Society of Clinical Oncology’s Annual Meeting –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) today announced results from a post-hoc exploratory analysis demonstrating that the efficacy benefits seen in the phase 3 CheckMate -9ER trial with CABOMETYX® (cabozantinib) in combination with Bristol Myers Squibb’s OPDIVO® (nivolumab) compared with sunitinib as a first-line treatment for advanced renal cell carcinoma (RCC) were observed across analyzed subgroups, including those based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk status, site of metastases and extent of tumor burden at baseline. The data will be presented as part of the Poster Session: Genitourinary Cancer – Kidney and Bladder at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held virtually, June 4-8, 2021. All posters will be available on demand beginning at 6:00 a.m. PT on Friday, June 4.\n\n“To inform treatment decisions, we are eager to gain a deeper understanding of how baseline disease characteristics may impact clinical outcomes for patients treated with cabozantinib in combination with nivolumab, and this analysis supports that the combination regimen may be an appropriate option in the first-line setting for a wide range of patients with renal cell carcinoma,” said Andrea Apolo, M.D., Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, who served on the study’s steering committee. “Some of the baseline characteristics, including the presence of bone metastases, are associated with worse outcomes, making it encouraging to see that the combination regimen demonstrated efficacy benefits in these patients.”\n\nAs presented at the ASCO 2021 Genitourinary Cancers Symposium (ASCO GU) in February 2021, at a median follow-up of 23.5 months in the CheckMate -9ER intent-to-treat population, median progression-free survival (PFS) was doubled at 17.0 months for CABOMETYX in combination with OPDIVO compared with 8.3 months for sunitini...