ChemoCentryx, Inc., (Nasdaq:CCXI) today announced the presentation of results from its immuno-oncology program at the American Society of Clinical Oncology (ASCO) 2017 Gastrointestinal Cancers Symposium being held January 19-21, 2017 in San Francisco, California.
The presentation highlights results from a continuing open-label, single-arm Phase Ib clinical trial of CCX872 when added to standard of care FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in patients with advanced non-resectable pancreatic cancer. CCX872 is a selective inhibitor of the chemokine receptor known as CCR2.
The primary efficacy measurement of the trial is progression-free survival (PFS) following 24 weeks of treatment. The pre-specified evaluable primary analysis population consisted of patients who had at least one post-baseline disease computerized tomography (CT) assessment. All patients enrolled in the trial had advanced non-resectable pancreatic cancer (78% of patients having metastatic disease), and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of less than or equal to 2. Under the study protocol, patients may continue to receive CCX872 for an indefinite treatment period as long as there is no evidence of disease progression. Accordingly, 48 week overall survival data is also reported.
The results are presented in a poster entitled, "Orally Administered CCR2 Selective Inhibitor CCX872-B Clinical Trial in Pancreatic Cancer" (Abstract #276, January 20, 12:30 to 2:00 p.m. PT, Poster Session B: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract)
Data reported for CCR2 inhibitor CCX872 in combination with FOLFIRINOX are as follows:
PFS rate was 57% at week 24 in the primary analysis population; median PFS was 179 days
Overall survival rate was 52% at week 48 in the primary analysis population; median survival time was 11.5 months
The longest ongoing CCX872 treatment period for a patient in the study to date is 73 weeks (and continuing)
CCX872 has been well tolerated in the clinical trial. There is no apparent additional safety burden of combining CCX872 with FOLFIRINOX, as evidenced by an incidence and rate of adverse events in the trial to date which is consistent with data reported historically for FOLFIRINOX on its own.
In preclinical and clinical studies, inhibition of CCR2 in pancreatic cancer has shown to decrease tumor progression by blocking recruitment and accumulation of monocytes or macrophages that are thought to have an immune suppressive character in the tumor microenvironment. The Company is also examining current immunotherapy practices using model systems with so-called checkpoint inhibitors (such as anti-PD-1 or PD-L1) combined with chemokine receptor inhibitors including CX872. While it is known that checkpoint inhibitors on their own lack efficacy in immune-insensitive cancers (including pancreatic cancer), the Company has demonstrated that the inhibition of CCR2 potentiates anti-PD-1/PD-L1 immunotherapy in preclinical models of pancreatic cancer. The Company plans to further investigate CCX872 in combination with a checkpoint inhibitor.
"It is encouraging that a large percentage of patients with the notoriously challenging disease of pancreatic cancer are still alive in this ongoing study," said Pirow Bekker, M.D., Ph.D., and Chief Medical Officer of ChemoCentryx. "Given that all patients in our study had non-operable disease, the large majority of whom were also metastatic, we believe that any improvement in overall survival is an important advancement for this patient population. We will continue to follow these patients, and we look forward to the 18-month survival analysis later this year. Additionally, we are keen to further evaluate CCX872 in combination with a checkpoint inhibitor."
CCX872 Phase Ib Trial Design
The open-label, multi-center, Phase Ib clinical trial was designed to evaluate the safety and efficacy of orally administered CCX872 plus FOLFIRINOX in 50 patients with advanced non-resectable pancreatic cancer. Patients received 150 mg CCX872 twice daily for 12 weeks. After 12 weeks, patients who achieved stable disease or better (as measured by Response Evaluation Criteria In Solid Tumors, or RECIST 1.1) were eligible to continue on study for at least an additional 12 weeks unless disease progre...
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