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Exelixis Announces Detailed Results from Phase 3 COSMIC-312 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer at ESMO Asia Virtual Oncology Week 2021
– Exelixis intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in early 2022 following the final
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Exelixis intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in early 2022 following the final overall survival analysis –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced detailed results from the first planned analysis of COSMIC-312, the ongoing phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). The data are being presented at 7:00 p.m. SGT (6:00 a.m. EST, 3:00 a.m. PST) on Saturday, November 20 in the Virtual Plenary Session during the European Society for Medical Oncology (ESMO) Asia Virtual Oncology Week 2021.\n\nAs announced in June and presented today, at a median follow-up of 15.8 months, the primary analysis showed the primary endpoint of progression-free survival (PFS) per RECIST 1.1 by blinded independent review committee (BIRC) was met; in the PFS intent-to-treat (PITT) population, cabozantinib in combination with atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib (hazard ratio [HR]: 0.63; 99% confidence interval [CI]: 0.44-0.91; P=0.0012; pre-specified critical p-value of 0.01). Median PFS was 6.8 months for cabozantinib in combination with atezolizumab (n=250) versus 4.2 months for sorafenib (n=122).\n\nNew results presented during the 2021 ESMO Virtual Plenary include detailed data for a prespecified interim analysis for the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population, which was conducted at the same time as the primary analysis for PFS in the PITT population. At a median follow-up of 13.6 months, the interim OS analysis in the ITT population showed a trend that favored cabozantinib in combination with atezolizumab but did not reach statistical significance (HR: 0.90; 96% CI: 0.69-1.18; P=0.438). Median OS was 15.4 months for cabozantinib in combination with atezolizumab (n=432) versus 15.5 months for sorafenib (n=217). The trial is continuing as planned to the final analysis of OS, anticipated in early 2022.\n\n“We are encouraged by the significant improvement in progression-free survival observed in COSMIC-312, suggesting cabozantinib in combination with atezolizumab holds potential as a tr...