HL-398: Five-Year Overall Survival from the CheckMate 205 Study of Nivolumab for Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

Abstract

Context PD-1 immune checkpoint inhibitors, including nivolumab, have shown strong activity in patients with R/R cHL. The CheckMate 205 study demonstrated an objective response rate (ORR) of 69%, a median duration of response (DOR) of 17 months, and median progression-free survival (PFS) of 15 months, at a median follow-up of 18 months. Objective Assess the longer-term outcomes of CheckMate 205 with a median follow-up of 58 months. Design CheckMate 205 (NCT02181738) enrolled patients with R/R cHL after auto-HCT failure into three cohorts by treatment history: (A) brentuximab vedotin (BV)-naive, (B) BV after auto-HCT, and (C) BV before and/or after auto-HCT. Interventions Nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. Patients in cohort C discontinued nivolumab after 1 year in complete remission (CR) with the option to resume within 2 years if relapsed. Outcome Measures Primary: ORR. Others: CR, DOR, PFS, overall survival (OS), and safety. Results Overall, 243 patients were treated. Median duration of treatment was 14 months. ORR was 71% (95% CI, 65%–77%), and CR rate was 21%. Median PFS was 15 months (95% CI, 11–19), and median DOR was 18 months (95% CI, 15–26). The 2-year and 5-year OS rates (95% CI) were 87% (82%–91%) and 71% (65%–77%), and PFS rates were 37% (30%–44%) and 18% (12%–25%), respectively. Patients with CR had improved OS; failure to achieve disease control was a poor prognostic factor for OS. Per protocol, 12 patients in cohort C stopped treatment after ≥1 year of CR. After median of 48 months (range, 36–55) from last treatment, 6 patients were still in response; 3 were re-treated with nivolumab after disease progression (2 re-achieved CR; 1 partial response). The safety profile is similar to previous reports, and no new toxicities were observed. There were no treatment-related deaths. Conclusions This 5-year analysis of CheckMate 205 demonstrated favorable OS and confirmed the efficacy and safety of nivolumab for patients with R/R cHL after auto-HCT. It appears feasible to stop nivolumab after 1 year of CR and re-initiate treatment upon disease progression. Funding BMS. Previous presentation ICML 2021 PD-1 immune checkpoint inhibitors, including nivolumab, have shown strong activity in patients with R/R cHL. The CheckMate 205 study demonstrated an objective response rate (ORR) of 69%, a median duration of response (DOR) of 17 months, and median progression-free survival (PFS) of 15 months, at a median follow-up of 18 months. Assess the longer-term outcomes of CheckMate 205 with a median follow-up of 58 months. CheckMate 205 (NCT02181738) enrolled patients with R/R cHL after auto-HCT failure into three cohorts by treatment history: (A) brentuximab vedotin (BV)-naive, (B) BV after auto-HCT, and (C) BV before and/or after auto-HCT. Nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. Patients in cohort C discontinued nivolumab after 1 year in complete remission (CR) with the option to resume within 2 years if relapsed. Primary: ORR. Others: CR, DOR, PFS, overall survival (OS), and safety. Overall, 243 patients were treated. Median duration of treatment was 14 months. ORR was 71% (95% CI, 65%–77%), and CR rate was 21%. Median PFS was 15 months (95% CI, 11–19), and median DOR was 18 months (95% CI, 15–26). The 2-year and 5-year OS rates (95% CI) were 87% (82%–91%) and 71% (65%–77%), and PFS rates were 37% (30%–44%) and 18% (12%–25%), respectively. Patients with CR had improved OS; failure to achieve disease control was a poor prognostic factor for OS. Per protocol, 12 patients in cohort C stopped treatment after ≥1 year of CR. After median of 48 months (range, 36–55) from last treatment, 6 patients were still in response; 3 were re-treated with nivolumab after disease progression (2 re-achieved CR; 1 partial response). The safety profile is similar to previous reports, and no new toxicities were observed. There were no treatment-related deaths. This 5-year analysis of CheckMate 205 demonstrated favorable OS and confirmed the efficacy and safety of nivolumab for patients with R/R cHL after auto-HCT. It appears feasible to stop nivolumab after 1 year of CR and re-initiate treatment upon disease progression. BMS. ICML 2021