New available results for two cohorts, one each from two studies evaluating Exelixis Inc.'s (EXEL:NASDAQ) cabozantinib in advanced colorectal cancer, were reported by H.C. Wainwright & Co. analyst Michael King.
As for the CAMILLA trial, 29 of the 36 enrolled Cohort 2 patients were evaluable. Among those the disease control rate was 86.2%, and median overall survival was 9.1 months. Median progression free survival (PFS) was 3.6 months, and PFS at six months was 34.5%.
Twelve evaluable patients in Cohort 2 had a wild type RAS gene. In this group, the disease control rate was 83.3%. Median progression free survival was 6.3 months. Median overall survival was 21.8 months.
Eleven participants had grade 3 or higher treatment-related adverse events (TRAEs), the most common of which included grades 1 to 2 fatigue (53%), nausea (42%), and diarrhea (36%). A fewer number of patients experienced grade 3 or higher immune-related adverse events. One patient discontinued durvalumab due to emergent adverse events.
For Cohort 16 of the COSMIC-021 trial, the primary endpoint was investigator assessed overall response rate. That was 10% (31 patients) at a median follow-up at 28.1 months. Wild type RAS patients had an overall response rate of 25%, whereas RAS mutated patients did not have any objective responses.
The most frequent TRAEs were diarrhea (52%), fatigue (42%), and nausea (35%). Grades 3 and 4 TRAEs occurred in 52% of patients, of which the most often occurring were hypertension (10%), fatigue (6%), and increased lipase (6%). Because of TRAEs, 6% of patients discontinued the double agent regimen, and 6% discontinued the single agent.
King concluded: "Clinical data generated from the COSMIC-021 and CAMILLA trials provide robust rationale to continue developing XL092 in novel combinatorial approaches and in an expansive repertoire of tumors, where cabozantinib has demonstrated meaningful clinical anti-tumor activity, in addition to efficacy."
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Disclosures for H.C. Wainwright & Co. LLC, Exelixis Inc., Jan. 19, 2022
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I, Michael G. King, Jr. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Exelixis, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity
securities of Exelixis, Inc.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Exelixis, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from Exelixis, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in Exelixis, Inc. as of the date of this research report.