The Targeted Pulse: Sniffing out the Latest From ASCO GI 2025 and Fresh FDA Activity

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Aspirin reduced recurrence by 50% in PIK3CA-mutated colorectal cancer, the DCISionRT test earned FDA breakthrough status for predicting radiotherapy benefit in DCIS, and nivolumab plus chemotherapy sustained efficacy in gastric/GEJ/esophageal cancers. We also provide an overview of key abstracts from ASCO GI and molecular oncology and how it is changing care.

Aspirin Use Reduced PIK3CA-Mutated Colorectal Cancer Recurrence by 50%

Aspirin use reduced cancer recurrence by 50% in patients with PIK3CA-mutated colorectal cancer, according to 3-year data from the ALASCCA trial (NCT02647099). In the trial, patients were randomly assigned to receive either aspirin or placebo. Investigators found that the benefit of aspirin was consistent across all patient subgroups. These findings were presented during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium.

“This is the first trial to show that mutations in this specific signal pathway, also beyond PIK3CA, predict aspirin response, expanding the target population to more than a third of the patients [with non-metastasized colorectal cancer],” Anna Martling, MD, PhD, FACS, FASCRS, Karolinska Institutet, Lund University, Akademiska University Hospital, Uppsala Sweden, said during a presentation of the results. “This is also an example of repurposing a safe, inexpensive, and globally available drug and it stresses the importance of genomic testing in patients with colorectal cancer.” For the full details, access the coverage here.

Risk-Assessment Tool, DCISionRT Test, Scores Breakthrough Status in DCIS

DCISionRT test, a risk assessment device designed to predict radiation therapy benefit in ductal carcinoma in situ (DCIS), has received breakthrough therapy designation from the FDA. In the PREDICT study (NCT03448926), the DCISionRT test was found to be a key asset in solidifying treatment decisions for patients with DCIS due to its ability to determine which patients are most likely to benefit from radiotherapy.

“What the study shows is that the use of the DCISionRT 7-gene biosignature is the factor that has the most significant impact on decision making. It is key for patients working with their clinicians and having an informed discussion about the benefits of radiation therapy,” explained Chirag Shah, MD, radiation oncologist at Cleveland Clinic, codirector of the comprehensive breast cancer program, and director of breast radiation oncology, in an interview with Targeted OncologyTM. For additional details on the DCISionRT test’s functionality, access the complete article here.

Long-Term Nivolumab/Chemotherapy Still Effective in Gastric/GEJ/Esophageal Cancers

Five-year follow-up data show that first-line nivolumab (Opdivo) with chemotherapy continues to elicit favorable overall survival rates vs chemotherapy alone in patients with advanced gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC). These data come from the phase 3 CheckMate 649 trial (NCT02872116), which were presented by Yelena Y. Janjigian, MD, during the 2025 ASCO GI Cancers Symposium.

“To our knowledge, these results represent the longest follow-up in a phase 3 trial of a programmed death-1 inhibitor plus chemotherapy in advanced GC/GEJC/EAC and continue to support nivolumab plus chemotherapy as standard first-line treatment,” said Janjigian, chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center in New York, New York. For complete data from the CheckMate 649 trial, access the full article here.

Community Oncologists’ Watch List for ASCO GI 2025 Abstracts

This article is an excellent resource for uncovering key abstracts from the 2025 ASCO GI Cancers Symposium. Inside, you will find concise, informative summaries of late-breaking abstracts, along with other abstracts that might otherwise get overlooked amidst the full slate of presentations. Organized by cancer type—gastric, GEJ, esophageal, and pancreatic cancers—this article provides a quick overview of the must-know takeaways from ASCO GI 2025.

“There is a lot of investigation going on, not only related to the development of new compounds, targeting different pathways…but also in the identification of patients who benefit more or less from available therapies,” explained Bruno Sangro MD, PhD, head of Hepatology Unit, Internal Medicine Department, Clinica Universidad de Navarra, Spain, in an interview with Targeted OncologyTM regarding the ASCO GI Symposium. To access this resource, we ask for information about you to better tailor our offerings. Click here to get started and gain access to this article.

Molecular Oncology and the Shift Toward Individualized Care

Molecular oncology is transforming our understanding of cancer and revolutionizing treatment, enabling targeted therapies and more personalized care across various cancer types. This article explores how molecular oncology has reshaped clinical approaches to cancer diagnosis and treatment. Featuring insights from investigators, the article highlights the current advancements in molecular profiling and the promising path ahead, as there is still much to discover.

“What I would predict is that as all these massive amounts of data are coming in, patients are getting next-generation sequencing, we are going to find more targets, more mutations, other biomarkers that tell us what treatments may work for what patient but then you also have the added complexity of the sequencing of those treatments, as well as what comorbidities that patients may have,” Geoffrey D. Moorer, MD, medical oncologist at Virginia Cancer Specialists, told Targeted OncologyTM. To access this article, we ask for information about you to better tailor our offerings. Click here to begin and gain access to this article.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

In case you missed it, here is last week’s Targeted Pulse.

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