Extended follow-up results of the CheckMate 205 study (NCT02181738)were published in the Journal of Clinical Oncology by Philippe Armand, medical oncologist at the Dana-Farber Cancer Institute, Boston, and colleagues on 27 March 2018.
The CheckMate 205 phase II study evaluated the safety and efficacy of nivolumab monotherapy in patients with relapsed and refractory (R/R) classical Hodgkin lymphoma (cHL) who have relapsed after autologous stem cell transplant (ASCT). The 12-month follow-up results were presentedat the American Society of Hematology Annual Meetingin Dec 2016.
Extended study follow-up overview
The study included an 18-month follow-up of 243 patients median age 34 (26–46), with an analysis taking place at database lock in December 2016. Patients were divided into three cohorts; brentuximab vedotin (BV) naive (cohort A, n = 63), BV after ASCT (cohort B, n = 80) and BV before and/or after ASCT (cohort C, n = 100). Patients received nivolumab 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. Primary endpoint included objective response rate assessed by an independent radiology review committee (IRC). Secondary endpoints included IRC-assessed duration of response (DOR), partial remission (PR), complete remission (CR) and investigator assessed ORR and DOR.
- IRC-assessed ORR for all patients = 69% (95% CI, 63–75%)
- Cohort A = 65% (95% CI, 52–77%)
- Cohort B = 68% (95% CI, 56–78%)
- Cohort C = 73% (95% CI, 63–81%)
- IRC-assessed CR for all patients = 16%
- Cohort A = 29%
- Cohort B = 13%
- Cohort C = 12%
- IRC-assessed median DOR for all patients = 16.6 months (95% CI, 13.2–20.3 months)
- Cohort A = 20.3 months
- Cohort B = 15.9 months
- Cohort C = 14.5 months
- Median progression-free survival for all patients = 14.7 months (95% CI, 11.3–18.5 months)
- Cohort A = 18.3 months
- Cohort B = 14.7 months
- Cohort C = 11.9 months
- 1-year overall survival for all patients = 92% (95% CI, 88–95%)
- Cohort A = 93% (95% CI, 83–98%)
- Cohort B = 95% (95% CI, 87–98%)
- Cohort C = 90% (95% CI, 82–94%)
- Most common grade ≥3 drug-related AEs; lipase increases (5%), neutropenia (3%) and ALT increases (3%)
- 29 deaths occurred that were not considered treatment related. The most common cause of death was disease progression (n = 18)
The authors noted that nivolumab demonstrated high response rates and durable responses after long term follow-up in patients with R/R cHL. Additionally, the study showed the nivolumab had an acceptable safety profile.
Nivolumab was granted accelerated approvalby the US food and drug administration(FDA) for R/R cHL patients who relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation BV on 17 May 2016. It also received positive opinionfrom the Committee for Medicinal Products for Human Use(CHMP) from the European Medicines Agency(EMA) to change the terms of the marketing authorisation so that nivolumab was indicated for R/R cHL after ASCT and treatment with BV.