KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Clinical Trial Results
Refractory or Relapsed PMBCL
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Clinical End Points from KEYNOTE-170
Objective Response Rate (ORR)
In 53 adult patients with refractory PMBCL, or who have relapsed after ≥2 prior lines of therapyResponse
Response
Additional Information
The median follow-up time in KEYNOTE-170 was 9.7 months.
For the 24 responders, the median time to first objective response (complete or partial response) was 2.8 months (range: 2.1 to 8.5 months).
Duration of Response (DOR)
KEYTRUDA |
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Median DORNot Reached(range: 1.1+ to 19.2+ months)a |
Study Design for KEYNOTE-170
Study Overview
Phase 2, Multicenter, open-label, single-arm study
KEYNOTE-170 study design: The efficacy of KEYTRUDA as a single agent was investigated in 53 patients with refractory or relapsed PMBCL enrolled in a multicenter, open-label, single-arm study.
- Patients with active, noninfectious pneumonitis, an allogeneic HSCT within the past 5 years (or greater than 5 years but with symptoms of 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 200 mg intravenously Q3W until unacceptable toxicity or documented disease progression, or for up to 24 months in patients who did not progress.
- Disease assessments were performed every 12 weeks and assessed by blinded independent central review according to the 2007 revised International Working Group criteria.
- Efficacy was based on overall response rate and duration of response.
Patient Characteristics:
KEYNOTE-170 (N=53) included patients with PMBCL who relapsed or were refractory to therapy, heavily pretreated, and/or had received prior autologous HSCT.
Refractory or relapsed
- 49% had relapsed disease refractory to the last prior therapy
- 36% had primary refractory disease
- 15% had untreated relapse
- Median number of prior lines of therapy was 3 (range: 2–8)
- 32% had prior radiation therapy
- 100% of patients received rituximab as part of a prior line of therapy
- 26% had received prior autologous HSCT
- 74% were autologous-HSCT naïve
Heavily pretreated
HSCT history