Exelixis Announces Detailed Results for Cabozantinib in Combination with Immunotherapies in Patients with Advanced Colorectal Cancer at ASCO GI 2022
January 18, 2022 at 05:30 pm
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Exelixis, Inc. announced results for cabozantinib (CABOMETYX®) in combination with immunotherapies in patients with advanced colorectal cancer, including encouraging data from cohort 16 of the phase 1b COSMIC-021 trial of cabozantinib in combination with atezolizumab in patients with metastatic colorectal cancer who were previously treated with fluoropyrimidine-containing chemotherapy. Results from cohort 2 of the phase 2 CAMILLA trial of cabozantinib in combination with durvalumab in patients with advanced mismatch repair proficient/micro satellite stable (pMMR/MSS) colorectal cancer patients who were chemotherapy-refractory were also announced. The data from these studies are being presented during Poster Session C: Cancers of the Colon, Rectum, and Anus on Saturday, January 22 at the 2022 American Society of Clinical Oncology's Gastrointestinal Cancers Symposium (ASCO GI).
At a median follow-up of 28.1 months, the primary endpoint of objective response rate (ORR) by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in cohort 16 (n=31) was 10%. The disease control rate (DCR; complete response + partial response + stable disease) was 71%. Median progression-free survival (PFS) was 3.0 months (95% confidence interval [CI]: 2.7-5.4), and median overall survival (OS) was 14.0 months (95% CI: 5.5-16.7). Median duration of response was 7.6 months (95% CI: 4.2-not estimable [NE]). A post-hoc exploratory analysis showed that patients with wild-type RAS (n=12) had longer PFS and OS compared with patients with RAS mutations (n=19): median PFS was 5.8 months (95% CI: 2.8-11.0) compared with 2.7 months (95% CI: 1.6-4.1), respectively, and median OS was 16.7 months (95% CI: 8.4-NE) compared with 8.7 months (95% CI: 4.7-15.9), respectively. ORR was 25% for patients with wild-type RAS and 0% for patients with RAS mutations.
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.