The Oncology Clinical Trials Alliance (Alliance) today announced that the U.S. Food and Drug Administration has accepted for review Genentech’s supplemental biological license application for the immunotherapy atezolizumab (Tecentriq®) for the treatment of patients with stage III colon cancer deficient in deoxyribonucleic acid (DNA) mismatch repair (dMMR). The application is supported by results from the Phase III Alliance ATOMIC (A021502) trial, sponsored by the National Cancer Institute (NCI) and conducted in partnership with Genentech, a member of the Roche Group, and the German group Arbeitsgemeinschaft Internistische Onkologie (AIO). This study demonstrated that adding atezolizumab to standard chemotherapy after surgery significantly improved patient outcomes.
Acceptance of the application by the FDA is an important milestone for the clinical research community and reflects the potential impact of the ATOMIC trial on the treatment landscape for patients with molecularly defined subtypes of early-stage colon cancer. The FDA is expected to make an approval decision by October 2026.
Acceptance of this application underscores the promise of personalized, biomarker-driven approaches to increasing treatments for cancer patients and the dedication of the patients, caregivers, researchers, and study staff who participated in the ATOMIC trial. We are pleased that discoveries made through collaborative research efforts funded by the National Cancer Institute will lead to regulatory reviews that will ultimately expand treatment options for patients with colon cancer. ”
Evanthia Galanis, MD, PhD, Chair, Oncology Clinical Trials Alliance Group
The ATOMIC trial enrolled 712 participants across the United States and Germany from September 2017 to January 2023 to evaluate an adjuvant treatment strategy for stage III colon cancer with dMMR. This study investigated whether adding atezolizumab to standard chemotherapy could improve outcomes in this biologically distinct population. Recently published research results New England Medical Journal This approach was shown to reduce the risk of cancer recurrence or death by 50%, with 86.3% of patients remaining disease-free after 3 years, compared to 76.2% of patients who received chemotherapy alone. These results represent the first demonstration of the benefit of immunotherapy in early-stage dMMR colon cancer.
“ATOMIC has answered important clinical questions and generated evidence that may inform future treatment decisions for patients with nonmetastatic dMMR colon cancer,” said Frank A. Sinicrop, MD, Alliance Research Chair, Professor of Oncology, and Mayo Foundation Clinical Research Fellow at the Mayo Clinic Comprehensive Cancer Center. “FDA acceptance reflects the power of the data and the dedication of everyone involved in completing this study.”
The study was designed with disease-free survival as the primary endpoint, with overall survival and safety as secondary endpoints. This design allowed us to comprehensively evaluate both the efficacy and safety of incorporating immunotherapy into the adjuvant treatment of stage III dMMR colon cancer.
Colorectal cancer remains the leading cause of cancer-related death worldwide. The standard adjuvant therapy for patients with stage III colon cancer has long been 5-FU-based therapy, such as the FOLFOX regimen, and chemotherapy with oxaliplatin. Although these treatments have improved outcomes, many patients remain at risk of relapse, highlighting the need for more effective biomarker-driven approaches, such as those evaluated in ATOMIC.
The latest National Comprehensive Cancer Network guidelines include ATOMIC findings and expand consideration of this treatment approach for patients with stage II T4bN0 colon cancer that is growing locally and outward but has not spread to lymph nodes or distant sites.
The Alliance ATOMIC (A021502) trial is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted at the Alliance-led, NCI-funded National Clinical Trials Network (NCTN). Genentech, a member of the Roche Group, supported this research through a joint research and development agreement with NCI.
sauce:
Alliance for Clinical Trials in Oncology
