On September 1, 2016 ChemoCentryx, Inc., (Nasdaq:CCXI) reported initial 12 week overall response rate (ORR) results from an ongoing open label, single arm Phase Ib clinical trial with CCX872 in patients with advanced pancreatic cancer (Press release, ChemoCentryx, SEP 1, 2016, View Source [SID:1234514870]). CCX872 is a selective inhibitor of the chemokine receptor known as CCR2. Schedule your 30 min Free 1stOncology Demo! The ongoing Phase Ib clinical study aims to evaluate the safety and effects of orally administered CCX872 when added to standard of care FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in patients with advanced non-resectable pancreatic cancer. 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. The Company expects to report progression-free survival (PFS) by the end of 2016.
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Patients enrolled in the study 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. In order to assess the initial treatment effect of CCX872, the study provided for assessment of overall response rate (ORR) based on computerized tomography (CT) imaging following 12 weeks of treatment.
The pre-specified evaluable ORR population consists of all patients who have at least one post-baseline disease CT assessment. Response rate results at 12 weeks of treatment were as follows:
Pre-Specified Evaluable
Patient Population1
(N=41) ITT
Patient Population
(N=50)
Tumor control rate2 32/41 (78%) 32/50 (64%)
Overall response rate3 15/41 (37%) 15/50 (30%)
Stable disease 17/41 (41%) 17/50 (34%)
Progressive disease 9/41 (22%) 9/50 (18%)
Not evaluable4 9/50 (18%)
1 Pre-specified as the primary efficacy population = pre-defined as all patients who have a least one post baseline CT scan. ITT = all patients randomized, including those with no post baseline CT scan.
2 Tumor control rate includes stable disease, partial response and complete response.
3 Overall response rate measured by Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST 1.1). All responses included in ORR were partial responses (PRs).
4 Not evaluable due to no post baseline CT scan due to early withdrawal.
CCX872 was well tolerated by advanced pancreatic cancer patients. The incidence and rate of adverse events were consistent with data reported historically for FOLFIRINOX alone, suggesting no apparent additional safety burdens of combining CCX872 with FOLFIRINOX.
"Advanced pancreatic cancer is particularly challenging to treat, and represents a very high unmet medical need," said Pirow Bekker, M.D., Ph.D., Chief Medical Officer of ChemoCentryx. "While some earlier work with this mechanism looked at non-metastatic pancreatic cancer patients, we were keen on examining the effects of CCR2 inhibition in non-operable, metastatic disease in a multi-center setting. Given patients in our study may continue to receive treatment with CCX872 for as long as they are in a progression-free state, we will continue the study according to plan and evaluate progression-free survival later this year. Those data, as well as the potential longer term survival beyond that time, will help us in determining how best to proceed with CCR2 inhibition for pancreatic cancer."
About CCX872 Phase Ib Trial Design
The open-label, multi-center, ongoing Phase Ib clinical trial is designed to evaluate the safety and efficacy of orally administered CCX872 plus FOLFIRINOX in 50 patients with non-resectable pancreatic cancer. Patients receive 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), are eligible to continue on study for at least an additional 12 weeks unless disease progression occurs. Per protocol, the Eastern Cooperative Oncology Group (ECOG) performance status of patients in the trial is 0, 1 or 2. The primary efficacy measurement of the trial is progression-free survival (PFS) following at least 24 weeks of treatment.
About Pancreatic Cancer
It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year. In the United States, the annual incidence of pancreatic cancer is approximately 45,000; prevalence is only negligibly higher owing to the poor survival rates on current therapy. Within five years of diagnosis, 93 percent of patients die from their disease. Current standards of care include chemotherapeutic regimens that have significant toxicities and, in a minority of cases, surgical resection.