Dr Élez on Health-Related QOL With Nivolumab Plus Ipilimumab in mCRC

“[These QOL data] are important because when we are using a doublet, the addition of an extra drug has the potential to [introduce] more toxicity and [affect] quality of life [QOL]. [Instead], we saw that there was a trend towards QOL improvement with the doublet [of ipilimumab plus nivolumab compared with nivolumab monotherapy].”

Elena Élez, MD, PhD, a medical oncology consultant at Vall d’Hebron University Hospital and a senior investigator at Vall d’Hebron Institute of Oncology, discussed health-related quality of life (QOL) data from the phase 3 CheckMate 8HW trial (NCT04008030) of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs nivolumab in patients with microsatellite instability-high metastatic colorectal cancer (mCRC).

Findings presented by Élez during the 2025 ESMO Gastrointestinal Cancers Congress revealed that patients who received the doublet (n = 296) experienced a significant progression-free survival benefit compared with those who received nivolumab monotherapy (n = 286; HR, 0.62; 95% CI, 0.48-0.81; P = .0003). Additionally, patients in the investigational arm experienced a numerical benefit in terms of QOL, depending on which scale was used, Élez explained.

Global health status per the EORTC QLQ-C30 scale showed a general improvement in both arms starting at week 7; patients in the combination arm exceeded the minimally important change from baseline threshold starting at week 21. Mean change from baseline in terms of EORTC QLQ-C30 physical functioning scores also showed a trend towards improvement starting at week 7, as did fatigue scores. Patients in the combination and monotherapy arms exceeded the minimally important change from baseline threshold for fatigue starting at weeks 21 and 85, respectively.

It is important that these QOL trends favor the doublet, because the addition of an extra drug to nivolumab introduces the potential for additional toxicity and could negatively affect patient QOL, Élez noted. However, this was not observed in their analysis, she concluded.