What the trial was testing
The DESTINY-CRC02 enrolled 122 patients with colorectal cancer. The study was sponsored by Daiichi Sankyo and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
38% of patients saw their tumors shrink with the lower dose of trastuzumab deruxtecan.
The Lancet. Oncology · 2024 · NCT04744831
These findings — that saw their tumors shrink with the lower dose — were published in the The Lancet. Oncology and represent the headline result of the study.
Researchers tracked outcomes across 122 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with colorectal cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial-stage study testing the best dose of trastuzumab deruxtecan for HER2-positive colorectal cancer. The treatment is not yet FDA-approved for colorectal cancer. If you have HER2-positive colorectal cancer that hasn't responded to other treatments, ask your doctor about clinical trials testing this drug or other HER2-targeted therapies.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open colorectal cancer trials
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075.
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.