Pamrevlumab Plus Chemo Under Exploration in Novel Pancreatic Cancer Trial Platform

Anne-Marie Duliege, MD

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:

• Cedars-Sinai Medical Center
• Dana-Farber/Harvard Cancer Center
• Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance/University of Washington
• Johns Hopkins Medicine
• Memorial Sloan Kettering Cancer Center
• Moores Cancer Center at UC San Diego Health
• Perelman School of Medicine University of Pennsylvania
• Perlmutter Cancer Center/NYU Langone Health
• The University of Chicago
• The University of Texas MD Anderson Cancer Center
• UC San Francisco Helen Diller Family Comprehensive Cancer Center
• University of Florida Health – Cancer Center
• Virginia Mason Medical Center
• Washington University School of Medicine
• Weill Cornell Medicine

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.”

References

1. Pancreatic Cancer Action Network partners with FibroGen to bring new experimental treatment arm to adaptive clinical trial, Precision Promise. News release. Pancreatic Cancer Action Network. June 16, 2021. Accessed June 22, 2021. https://prn.to/35ReAC9
2. FibroGen granted fast track designation by US FDA for pamrevlumab treatment of patients with locally advanced unresectable pancreatic cancer. News release. FibroGen, Inc. March 1, 2018. Accessed June 22, 2021. https://bit.ly/2SiOPHR
3. Evaluation of efficacy and safety of neoadjuvant treatment with pamrevlumab in combination with chemotherapy (either gemcitabine plus nab-paclitaxel or FOLFIRINOX) in locally advanced pancreatic cancer. ClinicalTrials.gov. Updated June 1, 2021. Accessed June 22, 2021. https://clinicaltrials.gov/ct2/show/NCT03941093
4. Pancreatic Cancer Action Network announces groundbreaking clinical trial platform transforming development of treatment options for world’s toughest cancer. News release. Pancreatic Cancer Action Network. October 13, 2020. Accessed June 22, 2021. https://bit.ly/2IQhq2b