Exelixis, Inc. Announces Results for Combination of Cabozantinib and Nivolumab with or Without Ipilimumab in Advanced Hepatocellular Carcinoma
January 24, 2020 at 12:30 pm
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Exelixis, Inc. announced phase 1/2 clinical trial results from the combination of cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®) in advanced hepatocellular carcinoma (HCC). Data from the cabozantinib combination cohort of the CheckMate 040 trial will be presented on January 24 during Rapid Abstract Session B from 7:00 – 7:45 a.m. PT at the 2020 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI), which is being held in San Francisco, California, January 23-25, 2020. The data will also be included in Poster Session B from 12:00 – 1:30 p.m. PT and 4:30 – 5:30 p.m. PT on January 24. CheckMate 040 is a phase 1/2 study that includes an exploratory cohort of patients with advanced HCC who were either treatment naïve (41%) or who were intolerant to or had progressed on prior sorafenib therapy (59%). For the 36 patients treated with the combination of cabozantinib and nivolumab (17 treatment naïve [47%] and 19 with prior sorafenib therapy [53%]), the investigator-assessed objective response rate (ORR) was 19%, and disease control rate (DCR) was 75%. Median progression-free survival (PFS) was 5.4 months, and median overall survival was 21.5 months. For the 35 patients treated with the combination of cabozantinib, nivolumab and ipilimumab (12 treatment naïve [34%] and 23 with prior sorafenib therapy [66%]), the investigator-assessed ORR was 29%, and DCR was 83%. Median PFS was 6.8 months, and median overall survival had not yet been reached. No new safety signals were identified in this combination cohort. Treatment-related grade 3 or 4 adverse events were observed in 47% of the cabozantinib and nivolumab group; events occurring in more than 5% of patients were hypertension (11%), diarrhea (11%), aspartate aminotransferase (AST) increase (8%) and lipase increase (6%). Treatment-related grade 3 or 4 adverse events were observed in 71% of the cabozantinib, nivolumab and ipilimumab group; events occurring in more than 5% of patients were AST increase (23%), lipase increase (17%), ALT increase (17%), hypertension (17%) and palmar-plantar erythrodysaesthesia (9%). Discontinuation rates due to treatment-related adverse events were 11% for the cabozantinib and nivolumab group and 20% for the cabozantinib, nivolumab and ipilimumab group.
Exelixis, Inc. is an oncology company. The Company is engaged in developing medicines and combination regimens at the forefront of cancer care. It has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been also approved as CABOMETYX tablets for advanced renal cell carcinoma (RCC), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), and as COMETRIQ capsules for progressive, metastatic medullary thyroid cancer (MTC). The Company's other two products are COTELLIC, an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and MINNEBRO an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR) approved the treatment of hypertension.