Mar 20 2015
Cerulean Pharma Inc., a leader in Dynamic Tumor Targeting™, today announced that a Phase 1b/2 trial of its lead nanoparticle-drug conjugate, CRLX101, in combination with Avastin® in relapsed renal cell carcinoma (RCC) achieved its primary endpoint of at least 50% of patients achieving four months of progression free survival (PFS).
Data from this trial have been submitted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2, 2015) and will be submitted for publication in a peer-reviewed journal later this year.
Notably, as of the ASCO submission (February 3, 2015), preliminary top-line data from this trial showed a median PFS of 9.9 months. The current standard of care in the 3rd and 4th line setting for the treatment of relapsed RCC provides approximately 3.5 months of PFS1. As of the ASCO submission, the RECIST response rate from this trial was 23%. Standard of care in this setting provides a 2-4% response rate1. In this trial, CRLX101 and Avastin have been generally well tolerated with no unexpected toxicities.
“The top-line results from this trial in a difficult-to-treat patient population are encouraging,” said Paul Friedman, M.D., Executive Chairman at Cerulean. “The median PFS of 9.9 months supports the rationale for our ongoing randomized Phase 2 trial of CRLX101 plus Avastin in 3rd and 4th line RCC.”
The ongoing 22-patient Phase 1b/2 study in relapsed RCC is an investigator-sponsored trial conducted at the University of Pennsylvania and Thomas Jefferson University Hospital with support from Cerulean. The last patient was enrolled in December 2014. Seven patients were still being treated at the time of the ASCO submission.
Cerulean’s ongoing randomized Phase 2 trial in 3rd and 4th line RCC is a company-sponsored trial being conducted at approximately 30 U.S. centers. Up to 110 patients will be enrolled. Up to 90 patients (45 in the treatment arm and 45 in the comparator arm) with clear cell RCC will be assessed to determine if the trial meets its primary endpoint. Up to 20 patients with non-clear cell RCC will be evaluated separately for response rate and PFS. For the primary endpoint, the trial is powered to show a 2.3-month improvement in median PFS over an expected 3.5 months in the comparator arm. Cerulean expects to release top-line primary endpoint data and overall response rate data from this trial in the second quarter of 2016.
Reference:
1. Motzer, RJ. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: An open-label, randomized Phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96.
Source http://www.ceruleanrx.com/