A new experimental treatment arm examining pamrevlumab in combination with gemcitabine and nab-paclitaxel as a first- or second-line treatment for patients with metastatic pancreatic cancer has been added to the novel clinical trial platform Precision Promise, which is being conducted by the Pancreatic Cancer Action Network.
A new experimental treatment arm examining pamrevlumab in combination with gemcitabine and nab-paclitaxel (Abraxane) as a first- or second-line treatment for patients with metastatic pancreatic cancer has been added to the novel clinical trial platform Precision Promise, which is being conducted by the Pancreatic Cancer Action Network (PanCAN).1
The addition of the new treatment arm to the platform marks the first investigative therapy to be offered as a frontline treatment on the study. As such, patients with newly diagnosed metastatic pancreatic cancer who are enrolled to the platform are now able to onto an investigative approach in the first line, and then move on to another experimental treatment in the second-line setting, should the first approach no longer be efficacious.
“By partnering with FibroGen to bring a first-line experimental treatment arm into Precision Promise, we are expanding options for the patients enrolling in this trial,” Anne-Marie Duliege, MD, chief medical officer of PanCAN, stated in a press release. “It is one of PanCAN’s major objectives to continue to bring innovative, experimental drugs like FibroGen’s pamrevlumab into this study in order to accelerate drug development and hopefully bring new therapies to market faster. [Patients with] pancreatic cancer can’t afford to wait.”
Pamrevlumab is a first-in-class antibody that inhibits the activity of connective tissue growth factor. In 2018, the agent was granted a fast track designation by the FDA for the treatment of patients with locally advanced unresectable pancreatic cancer and is currently being examined in combination with gemcitabine and nab-paclitaxel or FOLFIRINOX in this population as part of the phase 3 LAPIS trial (NCT03941093).2,3
Currently, an urgent and unmet need for new and effective treatment options for patients with pancreatic cancer remains. The key objective of the Precision Promise trial is to transform the clinical developmental process by providing a more rapid, efficient, patient-centric approach to evaluate novel therapeutic options that possess the potential to improve outcomes.
The design of the trial allows for patients to receive first- and second-line treatment options in 1 clinical trial. The effort also requires fewer patients to be enrolled to it. With traditional clinical trials, only 1 therapy is typically tested, it can take up to 7 years for results, and costs can range from $30 to $50 million. This platform allows for several treatments to be evaluated, can be done in as little as 3 years, and is estimated to be up to 50% cheaper.4
The study is currently enrolling patients to 1 of 15 Clinical Trial Consortium sites across the United States, including:
As many as 5 additional sites could be added by 2022 based on a strict set of criteria aimed at identifying institutions with strong pancreatic cancer programs and those in geographic areas that serve a diverse patient population to expand access to underserved communities.
“We are inspired by the mission of the Pancreatic Cancer Action Network and are excited to partner with them,” Mark Eisner, MD, MPH, chief medical officer of FibroGen, stated in a press release. “We share PanCAN's goal of accelerating the development of new treatment options for pancreatic cancer patients.”