Immune checkpoint inhibitor (ICI) has now become the new standard treatment for non-small-cell lung cancer (NSCLC). However, immune-related adverse events (irAEs) are frequently observed. Little is known about the difference of profiling of irAEs between nivolumab and pembrolizumab in advanced NSCLC patients in real world.
Patients with advanced NSCLC treated with ICI at Sendai Kousei Hospital (n = 137) between January 2016 to March 2018 were included in our study. Subjects were categorized into either the patients who were treated nivolumab (Nivolumab group) or pembrolizumab (Pembrolizumab group) and were evaluated with respect to profile of irAEs, objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
The following were observed: patient background (Nivolumab/Pembrolizumab group) number of cases 99/38 cases, median age 68/65 years old, male 79%/71%, development of irAEs 42%/63% [p = 0.047], development of irAEs ≥ Grade3 1%/21% [p> .001], Skin reaction 27%/39% [p = 0.238], Pneumonitis 7%/18% [p = 0.099], Thyroid dysfunction 13%/8% [p = 0.577], Hepatotoxicity 2%/11% [0.087]. The development of irAEs was significantly higher in the Pembrolizumab group than in the Nivolumab group (63% vs 42%, respectively; p = 0.047). The development of irAEs ≥ Grade3 was significantly higher in the Pembrolizumab group than in the Nivolumab group (1% vs 21%, respectively; p > .001). Further, in patients with PD-L1 expression 1% to 49%, we compared Nivolumab (14 cases) and Pembrolizumab group (16 cases) after second-line treatment. The development of irAEs 64%/44% [p = 0.299], development of irAEs ≥ Grade3 0%/13% [p = 0.485], ORR 21%/13% [p = 0.642], median(months) PFS 4.1/3.6 [HR (95%CI) 1.17 (0.51-2.65), p = 0.712] . No significant differences in both development of irAEs, ORR and PFS have been observed.
Nivolumab group might be associated with a lower incidence of severe irAEs as compared to Pembrolizumab group. However, in patients with PD-L1 expression 1% to 49% after second-line treatment, there are no significant differences in both groups. Further studies with large patient samples are needed to validate these findings.
Clinical trial identification
Legal entity responsible for the study
Sendai Kosei Hospital.
Has not received any funding.
S. Sugawara: Ono Pharmaceutical co. Bristol-Myers Squibb MSD. All other authors have declared no conflicts of interest.