The combination of low-dose, weight base ipilimumab and flat-dose nivolumab demonstrate safety and efficacy as first-line treatment for patients with stage IV non-small cell lung cancer and comorbidities that traditionally preclude them from enrolling in clinical trials, according to results of the single-arm, nonrandomize CheckMate 817 study presented at International Association for the Study of Lung Cancer World Conference on Lung Cancer.
Non small cell lung cancer
This special population of patients include those with a poor ECOG performance status; asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV infection. Fabrice Barlesi, MD, PhD, professor of medicine at Aix-Marseille University and Assistance Publique Hôpitaux de Marseille in France; and also colleagues conduct CheckMate 817 due to the limit data on safety and efficacy of immunotherapy in patients with advance NSCLC and these comorbidities.
The study included two cohorts. Cohort A included 381 patients with an ECOG performance score of 0 to 1. Cohort A1 included 198 patients with an ECOG performance status of 2 which indicates a patient is ambulatory but cannot engage in most work activities as well as patients with an ECOG performance status of 0 to 1 and either asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV infection. No patients had receive prior systemic therapy; also no patients harbored EGFR or ALK mutations.
Patients received 240 mg IV nivolumab (Opdivo, Bristol-Myers Squibb) every 2 weeks with 1 mg/kg IV ipilimumab (Yervoy, Bristol-Myers Squibb) every 6 weeks until disease progression or unacceptability toxicity; for up to 2 years. The occurrence of select grade 3 to grade 5 treatment relate adverse events; also immune mediate adverse events serve as the primary endpoint. Secondary endpoints include PFS; overall response rate, duration of response and OS.
Encouraging activity in patients
“These data show an important piece of information that for those [special cohorts of patients]; this regimen is as safe as it is for the general population,” Barlesi said during a press conference. “The treatment relate adverse events leading to discontinuation; which also were comparable and treatment relate deaths were very low in both cohorts.”
“This study show a consistent safety profile across both a general; ECOG performance status of 0-1 population those who are usually including in clinical trials and a special population; including those with ECOG performance status of 2 or comorbid conditions; patients who are usually exclude from clinical trials,” Barlesi said. “Overall, the safety profile was consistent with prior studies using weight base nivolumab.”
The data also suggest encouraging activity in these patients, he added. “But, as expect unfortunately, globally the outcomes of this population; were lower than those with a better ECOG poor performance status,” Barlesi said. “But, despite this poor performance status and commodities, those patients achieve durable responses with nivolumab and ipilimumab