The results from two phase III clinical trials for pancreatic cancer patients were recently announced. Both Lilly’s SEQUOIA and Halozyme’s HALO-301 clinical trials reported that they did not reach their primary endpoint (goal) of improving overall survival for patients.
“While we’re disappointed to see the outcomes of these two clinical trials, the pancreatic cancer research and treatment field will learn from these results and use the information to guide future trials,” said Donna Manross, vice president of Scientific and Medical Affairs at the Pancreatic Cancer Action Network (PanCAN).
She continued, “Every treatment available today was approved through a clinical trial, and new treatments can only be approved after being tested in a clinical trial. We are grateful to patients for their willingness to participate in these and other trials, allowing the field to answer important questions.
“We at PanCAN strongly recommend clinical trials at diagnosis and during every treatment decision.”
Lilly’s SEQUOIA clinical trial evaluated adding a drug called pegilodecakin to a chemotherapy combination known as FOLFOX (folinic acid, 5-FU and oxaliplatin), compared to FOLFOX alone. Pegilodecakin is an immunotherapy drug, aiming to activate the patient’s immune system to recognize and attack their tumor. Patients who participated in this trial had been diagnosed with metastatic pancreatic cancer and had previously received gemcitabine-containing chemotherapy.
Halozyme’s HALO-301 clinical trial tested an experimental drug called PEGPH20 in combination with the chemotherapies gemcitabine and ABRAXANE in patients with metastatic pancreatic cancer who had not received prior treatment. The goal of PEGPH20 is to break down components of the dense “stroma” that surrounds and infiltrates pancreatic tumors, with the intention to enhance drug delivery to the cancer cells.
Both trials’ results showed the addition of the experimental drug did not improve overall survival for patients compared to chemotherapy alone.
“Other clinical trials and research efforts are underway to bring effective immunotherapeutic approaches to pancreatic cancer and to better understand and disrupt the complex stroma,” Manross said. “Using the learnings from these two clinical trials, the field will continue to move forward with the goal of developing new therapies and combinations that improve survival and outcomes for pancreatic cancer patients.”
It’s also important to note that through all clinical trials, patient safety is at the forefront. “The goals of the multistage clinical trial process include determining the optimal dose of a drug and ensuring its safety, in addition to finding out whether it’s an improvement over standard of care options for that patient population,” Manross said.
PanCAN’s PanCAN Patient Services can provide information about pancreatic cancer clinical trials, including a personalized list of clinical trials based on the patient’s geography, diagnosis and treatment history. PanCAN’s Clinical Trial Finder online search tool is also available to patients, caregivers and healthcare professionals to explore options.