Sherise Rogers, MD, MPH, an assistant professor of Hematology/Oncology at University of Florida Health (UFH), Division of Hematology and Oncology, Department of Medicine in the College of Medicine, discusses the rationale for investigating irinotecan liposome injection (Onivyde) plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin (NALIRIFOX) in the preoperative treatment of patients with pancreatic adenocarcinoma.

At the 2023 ASCO Annual Meeting, Rogers and colleagues shared the rationale for investigating NALIRIFOX in the ongoing phase 2 NEO-Nal-IRI trial (NCT03483038), which is evaluating its safety and activity in patients with newly diagnosed borderline resectable or resectable pancreatic cancer without overt metastatic disease.

Findings from the phase 3 NAPOLI 3 trial (NCT04083235) demonstrated that NALIRIFOX produced a clinically meaningful and statistically significant improvement in overall survival (OS) vs nab-paclitaxel (Abraxane) plus gemcitabine in the first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDAC). In June 2023, 

the FDA accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen

 as a first-line treatment for patients with metastatic (PDAC).

Based on these promising outcomes, the phase 2 NEO-Nal-IRI will evaluate NALIRIFOX as a novel regimen in the neoadjuvant setting, Rogers says. Investigators are excited to better understand if this approach may improve postoperative complication rates, she explains, noting that the primary objectives of this ongoing study are safety and feasibility.

The hope for this trial is to further address the unmet needs that remain in the treatment landscape for patients with pancreatic cancer, she continues. Overall, pancreatic cancer has a very dismal prognosis with a low OS rate, creating the desperate need of new therapies to improve these outcomes in patients, she concludes.

Enrollment for NEO-Nal-IRI has been completed, and no unexpected toxicities have been reported thus far. Primary results are anticipated in 2024.

Videos

Sherise Rogers, MD, MPH, discusses the rationale for investigating irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin in the preoperative treatment of patients with pancreatic adenocarcinoma. 


Dr Rogers on the NEO-Nal-IRI Trial in Pancreatic Adenocarcinoma

Sherise Rogers, MD, MPH, an assistant professor of Hematology/Oncology at University of Florida Health (UFH), Division of Hematology and Oncology, Department of Medicine in the College of Medicine, discusses the potential of utilizing circulating tumor DNA (ctDNA) to help guide second-line treatment decisions in patients with metastatic colorectal cancer (mCRC).

According to information presented at the 2023 Gastrointestinal Cancers Symposium, the phase 2 RAPID 1 trial (NCT04786600) is evaluating the use of the Signatera ctDNA assay as an assessment tool for response to therapy compared with the standard approach with a CT scan.

The trial in enrolling patients with mCRC who had progression on or intolerance to first-line chemotherapy. Patients who have measurable ctDNA at baseline will be randomly assigned to ctDNA-guided intervention or the scan-guided control group. The study will compare overall survival, progression-free survival, and best overall response.

The current standard of care is to use a CT scan every 3 months to evaluate the efficacy of second-line treatments in patients with mCRC. Investigators are aiming to understand if ctDNA can be used as a rapid assessment tool, Rogers explains. When patients need to wait every 3 months for assessment by CT scan, that represents to that a patient may be on a treatment without knowing if the treatment is actually working, Rogers says.

Additionally, during the 3-month intervals between CT scans, a patient can also experience significant adverse effects (AEs) that can worsen a patient’s morbidity and their quality of life, Rogers continues. Overall, all clinicians want to ensure that they are limiting significant AEs and optimizing treatments for patients in the second-line setting.

ctDNA has the potential to give a faster indication of whether a patient is receiving a benefit from a.second-line treatment, which would allow clinicians to switch to another therapy that could improve outcomes, Rogers concludes.

Sherise Rogers, MD, MPH, discusses the potential of utilizing circulating tumor DNA to help guide second-line treatment decisions in patients with metastatic colorectal cancer.

Sherise Rogers, MD, MPH

Articles

Dr Rogers on the NEO-Nal-IRI Trial in Pancreatic Adenocarcinoma

Dr. Rogers on the Potential for ctDNA to Aid Second-line Treatment Decisions in mCRC