Discussing Patient Characteristics in ESCC On Ipilimumab/Nivolumab

Ken Kato, MD, PhD, chief of the department of head and neck, and esophageal medical oncology and gastrointestinal medical oncology at the National Cancer Center Hospital in Tokyo, Japan, discusses the traits clinicians should look out for when seeing if a patient with esophageal squamous cell carcinoma (ESCC) is a candidate for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy).

Based on updated findings of the phase 3 CheckMate 648 trial (NCT03143153) that were presented at the 2023 ASCO Gastrointestinal Cancers Symposium, at a median follow-up of 28.8 months, the median overall survival (OS) for patients on nivolumab and chemotherapy (n = 321) was 12.8 months (95% CI, 11.1-15.7) vs 10.7 months (95% CI, 9.4-12.1) for patients on chemotherapy alone (n = 324). The 24-month OS rate also favored the combination vs chemotherapy alone at 29% vs 19%, respectively. For patients with a PD-L1 expression of 1% or higher, the median OS still favored the nivolumab combination arm at 15 months compared with 9.1 months in the chemotherapy arm (HR, 0.59; 95% CI, 0.46-0.76).

OS was significantly longer for patients with a PD-L1 expression of 1% or greater on ipilimumab/nivolumab compared with those on chemotherapy alone at a median of 13.7 vs 9.1 months, respectively (HR 0.64; 98.6% CI, 0.46-0.90; P = .001). Moreover, this result was also seen in the overall population of patients on ipilimumab/nivolumab compared with patients on chemotherapy alone at 12.7 vs. 10.7 months (HR, 0.78; 98.2% CI, 0.62 to 0.98; P = .01). These results were based on a preliminary analysis of the CheckMate 648 trial that Kato presented at last year’s ASCO GI Symposium, but according to Kato, they have continued to hold true in real world data.

Here, Kato discusses which patient profiles fit the best for use of the immunotherapy combination over chemotherapy alone in patients with an acceptable ECOG performance score and a strong PD-L1 positivity score. 

Transcription:

0:08 | We found the better response with [ipilimumab and nivolumab] and with longer follow-up, compared with the chemotherapy/nivolumab. We should focus on the patient who achieved a long-term efficacy [result] with ipilimumab and nivolumab.

0:26 | Last year, [we] presented [that for the] patient, [there is] already a benefit with ipilimumab/nivolumab. I think that the patient with a less aggressive disease with a small tumor burden, a good performance status, and good nutritional status, can be a good candidate for the ipilimumab/nivolumab treatment. Of course, the PD-L1 positivity is good and the predictive marker for the ipilimumab/nivolumab treatment, which we already [have seen] in the real-world data with ipilimumab/nivolumab and the patient background in the further evaluation.