low-dose ipilimumab in advanced NSCLC. Here we evaluate this regimen as first-line treatment in special populations (cohort A1) and a reference population (cohort A; previously reported). Method: Patients had previously untreated advanced NSCLC. Cohort A1 (n¼198) had ECOG PS 2 or ECOG PS 0e1 with 1 of: asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV. Cohort A (n¼391) had ECOG PS 0e1. Patients with known EGFR mutations or ALK translocations sensitive to available targeted therapy were excluded from both cohorts. Nivolumab 240 mg Q2W plus ipilimumab 1 mg/kg Q6W was administered for two years or until disease progression/unacceptable toxicity. Safety and efficacy endpoints were assessed; cohort A1 analyses were exploratory. Result: Cohort A1 patients were grouped as: ECOG PS 2 (n¼139) and all other special populations (AOSP; n¼59). Baseline characteristics were generally balanced between cohorts. Rates of grade 3e4 treatment-related adverse events (TRAEs) were similar between cohorts; within cohort A1, grade 3e4 TRAEs were numerically higher in AOSP versus the ECOG PS 2 subgroup; TRAEs leading to discontinuation were similar across populations (Table). ORR was 25% in cohort A1 (patients with ECOG PS 2, 20%; AOSP, 37%) and 35% in cohort A. PFS was numerically shorter in cohort A1 than cohort A; high TMB (10 mut/Mb) and higher PD-L1 expression (1% or 50%) were associated with numerically longer PFS in both cohorts (Table). Conclusion: First-line flat-dose nivolumab plus weight-based ipilimumab showed a consistent safety profile in special populations with advanced NSCLC, including those with ECOG PS 2. Patients with either high TMB or higher tumor PD-L1 expression appeared to exhibit improved efficacy.
median age was 63 years old (range 31w91). Nearly one third (56, 30.6%) of the patients had received at least three lines of prior therapies. The majority of the patients (148, 80.9%) were diagnosed as stage IV lung cancer, among them, 40 (21.9%) underwent prior surgery and 136 (74.3%) received prior chemotherapy. Of all the patients, the majority had an ECOG PS of 1 and 79 (69.4%) were histologically classified as adenocarcinoma. Overall, 127 patients were eligible for effectiveness evaluation, and of them, no patient achieved CR, 26 achieved PR, 84 achieved SD, and 17 showed PD, resulting in an ORR of 20.5% and a DCR of 86.7%. The primary study endpoint (PFS) and secondary endpoint (OS) has not been reached. Subgroup analysis revealed that the ORR and DCR values were slightly higher in patients received less than three lines of prior therapies than those in patients received at least three lines of prior therapies (ORR: 21.6% vs 18.8%; DCR: 87.8% vs 84.9%) The incidence of treatment-related AEs was 53.0% and grade 3-4 AEs were not observed. The most common AE caused by camrelizumab was reactive cutaneous capillary endothelial proliferation (REECP) (24.4%). Conclusion: In the real-world setting, advanced NSCLC patients with an older age, stage IV disease, cancer type of adenocarcinoma or ECOG PS 1 were more likely to be treated with camrelizumab. Camrelizumab monotherapy or in combination with chemotherapy and/or antiangiogenic agent were proved to be effective and safe in advanced NSCLC patients. Further study with a larger sample size is needed to explore the most potential camrelizumab-based therapeutic regimen for NSCLC patients.
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