Gulam Manji, MD, Highlights Promising Clinical Trial at AACR Special Conference on Pancreatic Cancer
Pancreatic cancer is one of the most fatal cancers, with a low rate of early diagnosis and a poor prognosis in advanced disease. The 5-year relative survival rate for pancreatic cancer in the United States is only 12%, and new therapeutic options are needed.
Dr. Gulam Manji, associate professor of medicine at Columbia University Irving Medical Center, is leading an exciting new investigator-initiated, open-label, multicenter Phase 2 clinical trial evaluating first-line combination therapy for pancreatic ductal adenocarcinoma (PDAC). Promising data on the pilot stage of the clinical trial were presented at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer held in Boston, Massachusetts, September 27-30, 2023.
“The results from the pilot stage of our bench-to-beside clinical trial demonstrated promising tumor responses, some of which were durable. Given these encouraging findings, the randomized phase 2 clinical trial is soon to activate at five participating sites,” says Dr. Manji, who co-directs the Precision Oncology and Systems Biology research program at the Herbert Irving Comprehensive Cancer Center (HICCC) at Columbia/NewYork-Presbyterian.
The Phase 2 trial evaluates the CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC). Preliminary results showed a durable partial response rate of 64% and disease control rate of 91%. Historic response rates and disease control rates with gemcitabine and nab-paclitaxel are 23% and 48%, respectively.
Based on these results, the study was amended to transition to a randomized phase 2 trial testing nab-paclitaxel compared to gemcitabine (N=108). The primary endpoint is progression free survival (PFS). A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois.