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Exelixis Announces Detailed Results from Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Kidney Cancer at ESMO 2022

– Cabozantinib in combination with nivolumab and ipilimumab significantly reduced the risk of disease progression or death compared with the combination of nivolumab and ipilimumab –

– Median progression-free survival was not yet reached with the combination of cabozantinib, nivolumab and ipilimumab versus 11.3 months with nivolumab combined with ipilimumab –

Excerpt from the Press Release:

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from COSMIC-313, an ongoing phase 3 pivotal trial evaluating the combination of cabozantinib (CABOMETYX®), nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC). The data, including detailed results of the primary endpoint of progression-free survival (PFS), are being presented during the Presidential Symposium III (LBA8) on Monday, September 12 at 4:30 p.m. CEST at the 2022 European Society of Medical Oncology (ESMO) Congress.

“I look forward to presenting detailed results from COSMIC-313, which provide a clear look at the efficacy and safety profile for this combination of cabozantinib plus dual checkpoint inhibition,” said Toni Choueiri, M.D., Director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School. “As the first trial with a control arm of nivolumab plus ipilimumab, COSMIC-313 was designed to answer an important question of whether adding cabozantinib to dual checkpoint inhibition can improve outcomes for this poor- and intermediate-risk renal cell carcinoma patient population. I am pleased that the trial demonstrated a significant progression-free survival benefit in patients receiving the triplet combination.”

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