Diane Simeone, MD, director, Pancreatic Cancer Center, associate director, Translational Research, NYU Langone’s Perlmutter Cancer Center, discusses the Precision Promise trial for patients with metastastic pancreatic cancer.

The Pancreatic Cancer Action Network has designed an adaptive clinical trial platform called Precision Promise. This trial will have multiple experimental arms within the platform, and every patient will be comprehensively studied before and on therapy with biopsies. Currently, there are 12 centers around the country who are a part of Precision Promise, Simeone says. Another 6 sites will be brought onboard.

The goal of this trial is to organize clinical trials for pancreatic cancer in a different way, Simeone says. Findings with hopefully determine why some approaches work and why others don’t, and then taking that knowledge to design better, more informed clinical trials.

Multiple pharmaceutical companies are involved in Precision Promise, allowing a variety of different agents to be evaluated simultaneously.

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Diane Simeone, MD, director, Pancreatic Cancer Center, associate director, Translational Research, NYU Langone’s Perlmutter Cancer Center, discusses the Precision Promise trial for patients with metastastic pancreatic cancer.
 

Dr. Simone Discusses the Precision Promise Trial in Pancreatic Cancer

Diane Simeone, MD, director, Pancreatic Cancer Center, associate director, Translational Research, NYU Langone’s Perlmutter Cancer Center, discusses the importance of mutational analysis in the treatment of patients with pancreatic cancer.

Physicians have typically relied on a patient’s family history when treating pancreatic cancer. However, in many patients with cancer, a complete family history is not taken. Physicians also find that following germline analysis of sporadic pancreatic cancer, 10% to 12% of patients with no family history have a germline mutation. That includes genes that are associated with other specific cancers. Simeone says that in her practice, a patient came in with sporadic pancreatic cancer that had a mutation in the 

 gene, which is associated with melanomas and pancreatic cancer, even though the individual had no history of melanoma.

Physicians are beginning to understand that the pattern of tumor evolution in some families that have these mutations is not always what is expected. Simeone says that physicians must understand the broad portfolio of mutations that exist. If the goal of therapy is to improve cancer outcomes, early detection and prevention has to be part of the equation, states Simeone.

Dr. Simeone on the Importance of Mutational Analysis in Patients With Pancreatic Cancer

Diane Simeone, MD, director, Pancreatic Cancer Center, associate director, Translational Research, NYU Langone’s Perlmutter Cancer Center, discusses emerging subtypes of pancreatic cancer.

Physicians have yet to sort out all of the subtypes of pancreatic cancer, but several are coming to the forefront. One subtype, which is only a small percentage of patients, is microsatellite instability (MSI). Though this subgroup only accounts for 1% of pancreatic cancers, there is some data that suggest that this population may respond to immuno-oncology drugs. Based on the lethality of the disease, every patient with pancreatic cancer should be tested for MSI, says Simeone.

The second are mutations in the DNA-damage response (DDR) signaling pathway, including 

. These are also genes that have been found to be present in germline DNA. These tumors respond differently than other pancreatic cancers, and physicians should tailor therapy with that knowledge, says Simeone. DDR-mutant cancers make up approximately 20% of all pancreatic cancers. Therefore, every patient with pancreatic cancer should have germline and somatic mutational analysis, states Simeone.

Dr. Simeone on Emerging Subtypes of Pancreatic Cancer

Diane Simeone, MD, director, Pancreatic Cancer Center, associate director, Translational Research, NYU Langone’s Perlmutter Cancer Center, discusses unmet needs in the treatment of patients with pancreatic cancer.

Simeone says that the biggest challenge in pancreatic cancer is the extreme skepticism in the community. There are many new therapies that are available, as well as exciting new clinical trials, but only about 4% of patients with pancreatic cancer go on clinical trials, says Simeone.

However, there is a big move toward understanding who is at risk for pancreatic cancer. About 10% to 13% of patients that come into the clinic with a new diagnosis of pancreatic cancer have a germline mutation, Simeone says. Identifying those risk factors are important for treatment decisions, but they also have implications for family members. The overall goal is to shift the curve in order to diagnose pancreatic cancer earlier.

Diane Simeone, MD

Articles

Dr. Simone Discusses the Precision Promise Trial in Pancreatic Cancer

Dr. Simeone on the Importance of Mutational Analysis in Patients With Pancreatic Cancer

Dr. Simeone on Emerging Subtypes of Pancreatic Cancer

Dr. Simeone Discusses Unmet Needs in Pancreatic Cancer