ASCO GI 2022 | Phase II GERCOR NIPICOL: long-term updates

Romain Cohen, MD, PhD, Saint-Antoine Hospital, AP-HP, Paris, France, discusses results from the Phase II GERCOR NIPICOL (NCT03350126) study. This Phase II trial investigated the treatment of patients with microsatellite instability-high/mismatch repair-deficient (MSI/dMMR) metastatic colorectal cancer (mCRC) with nivolumab plus ipilimumab for a duration of 1-year. The standard of care (SOC) for this patient population are immune checkpoint inhibitors, however the optimal duration of treatment is unknown. Many regimens continue treatment with immune checkpoint inhibitors for up to 2-years which can lead to impractical treatment-related adverse events and discontinuation. The GERCOR NIPICOL trial explored a shortened duration of therapy. In this Phase II study, 57 patients with chemo-resistant, MSI-high metastatic colorectal cancer received 4 cycles of nivolumab plus ipilimumab for a maximum of 1-year. A median follow-up of 35 months demonstrated a progression-free survival (PFS) of 70% and an impressive 75% overall-survival (OS) in this heavily pre-treated population. 42 patients were alive and free of progression by the end of the 1-year study treatment period, with only 4 PFS events thereafter and a 93% PFS rate by 2-years. It was concluded that the combination of nivolumab plus ipilimumab to treat patients with MSI/dMMR cCRC for a duration of 1-year demonstrated similar effectiveness to what has previously been reported in trials exploring 2-year treatment duration or longer. Dr. Cohen emphasizes that these results therefore challenge the requirement for a 2-year duration of treatment with immune checkpoint inhibitors for all patients whilst there is major uncertainty surrounding which patients require longer treatment periods. This interview took place at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.