CASI: Company Announces Positive Phase II Data on ENMD-2076 in Patients with OCCC At ASCO
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CASI: Company Announces Positive Phase II Data on ENMD-2076 in Patients with OCCC At ASCO
By Grant Zeng
NASDAQ:CASI
The Poster Presentation
During the 2016 ASCO meeting held June 3-7 at Chicago, CASI made a poster presentation about its lead candidate ENMD-2076 for ovarian clear cell carcinoma (OCCC).
OCCC represents 6% of all epithelial ovarian carcinomas and is associated with chemotherapy resistance and worse prognosis with advanced disease. Approximately 50% of OCCC are characterized by inactivating mutations in ARID1A and upregulation of PIK3/AKT/mTOR pathway. ENMD-2076, is an oral anti-angiogenic/anti-proliferative kinase inhibitor against the mitotic kinase Aurora A.
The poster title is: Antitumor Activity, Safety and Predictive Biomarker Results of ENMD-2076 Administered to Patients (pts) with Recurrent Ovarian Clear Cell Carcinoma (OCCC): A Trail of the Princess Margaret Phase II Consortium.
This is a multi-center, open-label, Phase II study of single agent ENMD-2706 (275 mg daily, 28 day
Cycle) in patients with recurrent OCCC.
The primary objectives include
• assessment of the anticancer activity of ENMD-2076 defined by the 6- month PFS rate,
• assessment of the objective response rate (ORR) using RECIST 1.1 criteria.
Secondary objectives include
• determination of duration of response
Exploratory objectives include
• correlation between somatic mutations in PI3KCA, ARID1A and PTEN and patient outcome.
• correlation between expression of ARID1A and PTEN by immunohistochemistry in archival samples and pretreatment tumor biopsies with patient outcome.
Data from 37 patients were presented. ENMD-2076 was generally well tolerated with a side effect profile typical of this class of agent.
6-month PFS rate was 0.16. 6-month PFS rate for ARID1A negative was 28% vs 0% for ARID1A positive. Overall response rate was 11%.
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The correlation of PIK3CA status and PFS was significant. In wild type PIK3CA patients, median PFS was 5.7 months vs 3.7 months in PIK3CA mutant patients (p=0.07).
The correlation between ARID1A-IHC status and PFS was also significant. In ARID1A-IHC negative patients, median PFS was 4.1 months vs 3.7 months for ARID-IHC positive patients (p=0.026).
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Our Takeaways from the data presentation
These data showed that ENMD-2076 demonstrated antitumor activity in OCCC and was generally well tolerated. We are especially interested in the correlation between PIK3CA/ARID1A status and ENMD-2076 antitumor activity. The significant relationships between wild type PIK3CA and PFS and between negative ARID1A and PFS are worth further investigation and may become a criteria for choosing OCCC patients in new clinical trials
