In adult patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy
CI = confidence interval; CR = complete response; DOR = duration of response; ORR = overall response rate; PR = partial response.
KEYNOTE-087 study design: The efficacy of KEYTRUDA as a single agent was investigated in 210 patients with refractory or relapsed cHL enrolled in a multicenter, open-label, nonrandomized study.
- Patients with active, noninfectious pneumonitis, an allogeneic hematopoietic stem cell transplantation (HSCT) within the past 5 years (or greater than 5 years but with symptoms of graft-versus-host disease [GVHD]), active autoimmune disease, a medical condition that required immunosuppression, or an active infection requiring systemic therapy were ineligible for the trial.
- Patients received KEYTRUDA at a dose of 200 mg intravenously Q3W until unacceptable toxicity or documented disease progression, or for up to 24 months in patients who did not progress.
- The major efficacy outcome measures assessed by blinded independent central review according to the 2007 revised International Working Group criteria were:
- Overall response rate
- Complete response rate
- Duration of response
Q3W = every 3 weeks.
- 58% refractory to the last
prior therapy
- 35% primary refractory disease
- 14% chemo-refractory to all
prior regimens
- 61% had received prior
autologous HSCT
- 39% were autologous
HSCT naïve
- Median number of prior lines
of therapy was 4 (range: 1–12)
- 83% had received prior
brentuximab vedotin
- 17% brentuximab vendotin naïve