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Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

(2)
Regulatory News:
Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that 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) met one of the primary endpoints, demonstrating significant improvement in progression-free survival (PFS) at the planned primary analysis. A prespecified interim analysis for the second primary endpoint of overall survival (OS), conducted at the same time as the primary analysis for PFS, showed a trend favoring the combination of cabozantinib and atezolizumab, but did not reach statistical significance. Based on the preliminary OS data, Exelixis anticipates that the probability of reaching statistical significance at the time of the final analysis is low. The trial will continue as planned to the final analysis of OS; results are anticipated in early 20 ....

France General , United States , Hong Kong , United Kingdom , New Zealand , South Korea , United Arab Emirates , Dominican Republic , Saudi Arabia , Russian Federation , Susan Hubbard , Michaelm Morrissey , Lindsay Treadway , Gemma Roper , Ipsen Euronext , Daiichi Sankyo Company , Drug Administration , Takeda Pharmaceutical Company , Exchange Commission , Exelixis Inc , International Agency For Research On Cancer , Public Affairs , European Union , Roche Group , Regulatory News , Exelixi President ,

Exelixis Highlights Positive Results for CABOMETYX (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU

® (cabozantinib) compared with sunitinib, the current preferred therapy according to U.S. cancer treatment guidelines,
1 in patients with metastatic papillary renal cell carcinoma (PRCC), a form of kidney cancer. The data from the S1500 trial (also called “PAPMET”), which was designed and managed by SWOG Cancer Research Network, will be presented on Saturday, February 13
th during the Oral Abstract Session: Renal Cell Cancer at 10:00 – 11:15 a.m. PT at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), which is being held virtually, February 11-13, 2021. The findings will be simultaneously published in
The Lancet.
“This is the first randomized trial specific to metastatic papillary renal cell carcinoma to show a clinically and statistically significant benefit with a targeted therapy, CABOMETYX, over an existing standard of care,” said Dr. Sumanta Pal, Clinical Professor and Co-Director of the Kidney Cancer Pro ....

United States , Susan Hubbard , Sumanta Pal , Lindsay Treadway , John Wright , Gisela Schwab , National Cancer Institute , Cancer Therapy Evaluation Program , Takeda Pharmaceutical Company , Product Development , Exelixis Inc , Kidney Cancer Program , Public Affairs , Cancer Research Network , Cancer Genome Atlas Research Network , European Union , American Cancer Society , Development Agreement , National Clinical Trials Network , Investigational Drug Branch , National Institutes Of Health , Exchange Commission , Research Network , Oral Abstract Session , Renal Cell Cancer , Clinical Oncology ,

Exelixis Announces Positive Findings at ASCO GU for CABOMETYX® (cabozantinib) in Patients with Brain Metastases from Renal Cell Carcinoma

Press release content from Business Wire. The AP news staff was not involved in its creation.
Exelixis Announces Positive Findings at ASCO GU for CABOMETYX® (cabozantinib) in Patients with Brain Metastases from Renal Cell Carcinoma
February 8, 2021 GMT
ALAMEDA, Calif. (BUSINESS WIRE) Feb 8, 2021
Exelixis, Inc. (NASDAQ: EXEL) today announced results from a retrospective analysis evaluating CABOMETYX ® (cabozantinib) activity in brain metastases in patients with renal cell carcinoma (RCC). The findings will be presented as part of the Poster Session: Renal Cell Cancer at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), which is being held virtually, February 11-13, 2021. All posters will be available on demand beginning at 5:00 a.m. PT on Thursday, February 11. ....

United States , Toni Choueiri , Susan Hubbard , Lindsay Treadway , Gisela Schwab , International Metastatic , Takeda Pharmaceutical Company , Database Consortium , Exchange Commission , Genitourinary Oncology At Dana Farber Cancer Institute , Lank Center , Product Development , Exelixis Inc , Public Affairs , European Union , Dana Farber Cancer Institute , American Cancer Society , Poster Session , Renal Cell Cancer , Clinical Oncology , Genitourinary Cancers Symposium , Genitourinary Oncology , Nancy Kohlberg Professor , Harvard Medical , Medical Affairs , Chief Medical Officer ,