The SUNLIGHT trial (NCT04737187) has shown promising results in the treatment of refractory colorectal cancer, particularly for patients seeking a third-line option who are not HER2+. This phase 3 trial built upon previous phase 2 findings, demonstrating the benefit of adding bevacizumab to TAS-102. With about 500 patients randomized, the study met its primary endpoint of overall survival, showing an improvement from approximately 7.5 months to 10.8 months, and more than doubling progression-free survival from about 2.5 months to 5.6 months. These results have led to the adoption of this treatment combination as a standard of care in the third-line setting in the United States.
Similarly, the FRESCO-2 trial (NCT04322539) evaluated the efficacy of fruquintinib, an oral VEGF inhibitor, in a more heavily pretreated patient population. This trial also met its primary endpoint of overall survival, with a hazard ratio of around 0.6, and is currently being submitted to the FDA and EMA for potential approval. The success of these trials represents a significant advancement in the treatment paradigm for refractory colorectal cancer, offering new therapeutic options and hope for improved patient outcomes.