medwireNews: Non-small-cell lung cancer (NSCLC) patients with poor performance status (PS) or comorbidity experience a similar adverse event (AE) rate to those with normal performance status when treated with nivolumab plus ipilimumab, say researchers.
Presenting data from the CheckMate 817 study at the IASLC World Conference on Lung Cancer 2019 in Barcelona, Spain, Fabrice Barlesi (Aix-Marseille Université, France) showed that treatment-related adverse events (TRAEs) of any grade occurred in 67% of 198 patients with an ECOG PS of 2 or an ECOG PS of 0–1 plus asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV.
By comparison, the rate was 77% among 391 patients with an ECOG PS of 0–1 and no other special features.
The rates of grade 3–4 TRAEs were 28% and 35% among the patients with and without special features, respectively, with a respective 15% and 22% of each group discontinuing treatment due to any grade of TRAE.
Within the cohort with special features, the proportion of grade 3–4 TRAEs was higher among the 59 patients with an ECOG PS of 0–1 plus comorbidities than among the 139 patients with an ECOG PS of 2, at 34% versus 26%.
Barlesi explained that, for CheckMate 817, patients received first-line nivolumab at a fixed dose of 240 mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks for up to 2 years or until disease progression or unacceptable toxicity.
However, previous studies of this combination among patients with NSCLC used weight-based dosing for nivolumab (3 mg/kg). The rates of grade 3–4 TRAEs in these studies were similar to the current study, at 29% in CheckMate 568 and 31% in CheckMate 227.
Barlesi also reported that the treatment combination showed “encouraging clinical activity” among the patients with special features, with an objective response rate of 24% overall, 19% in the patients with an ECOG PS of 2, and 37% among those with other special features.
The corresponding median response durations were 13.8, 14.2, and 9.7 months, while median progression-free survival (PFS) was 3.9, 3.6, and 4.2 months, respectively.
WATCH | Fabrice Barlesi takes us through the CheckMate 817 trial (3:32)
In addition, patients with a high tumor mutational burden (TMB; ≥10 mutations/Mb) and those with high PD-L1 expression (≥50%) had longer median PFS than those with low TMB (<10 mutations/Mb) or low PD-L1 expression (<1%), at 8.3 and 9.6 months versus 2.8 and 3.9 months, respectively.
Speaking at a press conference, Barlesi concluded that, for patients with ECOG PS 2 or other special features the flat-dose nivolumab plus weight-based, low-dose ipilimumab regimen “is as safe as it is for the general populations.”
He added that despite their poor ECOG PS and comorbidities these patients “achieved durable responses with nivolumab and ipilimumab, with a 1-year duration of response of 57%.”
By Laura Cowen
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IASLC World Conference on Lung Cancer 2019; Barcelona, Spain: 7–10 September