Treatment extends pancreatic cancer survival to 2 years: Trial data
Certepetide helps 6 of 10 treated along with pre-surgery chemotherapy
Six of 10 pancreatic cancer patients treated with the investigational drug certepetide along with chemotherapy prior to surgery were alive two years later, according to data from a Phase 1/2 study.
The study found the treatment safe and feasible, and analysis of tumor samples suggested increased immune activity within the tumors, developer Lisata Therapeutics said.
“The initial results from the CENDIFOX trial are very encouraging, showing that certepetide can enhance the effectiveness of standard-of-care chemotherapy in pancreatic cancer,” Kristen K. Buck, MD, executive vice president of research and development and chief medical officer at Lisata, said in a company press release. “We believe these findings are a significant step forward in a disease with few beneficial treatment options.”
The data were presented in a poster, “CENDIFOX: Phase I/II Trial of CEND-1 (LSTA1, certepetide) with Neoadjuvant mFOLFIRINOX in Resectable and Borderline Resectable PDAC,” at the American Association for Cancer Research (AACR) Special Conference in Cancer Research—Emerging Science Driving Transformative Solutions, held Sept. 28-Oct. 1 in Boston.
The new data relate to patients with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. Treatment for PDAC usually involves resection (a surgery aiming to cut out the tumor). Chemotherapy is often given before surgery to help shrink the tumor so it’s easier to remove completely, because if there are cancer cells left in the body the tumor may grow back.
Helping chemo drugs and immune cells target tumors
Certepetide is a cyclic peptide product — a small, ring-shaped protein molecule — that’s designed to activate molecular uptake pathways in tumor cells to make it easier for cancer-killing drugs to get deep into the tumor and eliminate cancer cells. Data show that certepetide may also modulate the tumor’s molecular environment so it’s easier for immune cells to attack the tumor.
“By improving drug delivery and modulating the tumor microenvironment to re-engage the immune system, we see a path forward for this program and the potential to change the outlook for patients,” Buck said.
The new data come from the Phase 1/2 CENDIFOX study (NCT05121038) testing regimens using certepetide in people with resectable or borderline resectable PDAC, as well as other types of solid tumor cancers. The investigator-initiated study is led by Anup Kasi, MD, a researcher at the University of Kansas Cancer Center.
“The ability of certepetide to improve drug delivery and influence the tumor microenvironment may offer a potential new and exciting treatment approach for pancreatic cancer,” Kasi said. “We are optimistic studies like CENDIFOX will pave the way for more effective combination therapies for difficult-to-treat solid tumor cancers.”
In the PDAC arm of the trial, patients undergo six, 14-day-long cycles of treatment with FOLFIRINOX, which is a chemotherapy regimen that uses several drugs given in a specific order. In the final three cycles of treatment, patients also are given certepetide. After completing all six cycles, patients undergo surgery aiming to remove the tumor.
The new data show that, out of 35 enrolled patients, 10 completed the full six courses of treatment followed by surgery. Of these, half had no residual cancer at the surgical margins, indicating that the entire tumor was successfully removed. Seven of the 10 patients had a pathologic partial response, reflecting a decrease in tumor burden. Most patients lived a year or longer after treatment with no disease progression, and six of the 10 were still alive at two years after treatment.
Biomarker data from the study indicated that certepetide treatment increased the activity of cancer-attacking immune cells, and safety data showed no serious side effects related to the experimental therapy.
“The preliminary trial data has been very promising, and we’re excited to share these findings with the broader oncology community,” Kasi said.
Another Phase 1b/2a trial, called iLSTA (ACTRN12623000223639), is also testing certepetide in combination with other therapies in PDAC patients. Preliminary data from that study, announced earlier this year, showed most people with unresectable PDAC saw the size of their tumors shrink after several rounds of treatment with certepetide combos.
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