In adult patients with refractory primary mediastinal large B‑cell lymphoma (PMBCL), or who have relapsed after 2 or more
prior lines of therapy
- 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).
- Median duration of response among the 24 responding patients had not been reached at the time of analysis (range: 1.1+ to 19.2+ months).
The median follow-up time in KEYNOTE-170 was 9.7 months.
Pediatric Use:
The use of KEYTRUDA in pediatric patients is based on information from studies of KEYTRUDA in adults and additional studies in pediatric patients. There is limited experience in pediatric patients.
CI = confidence interval; CR = complete remission; ORR = overall response rate; PD-L1 = programmed death ligand 1; PR = partial remission; Q3W = every 3 weeks.
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.
- The efficacy outcome measures were based on overall response rate and duration of response.
HSCT = hematopoietic stem cell transplantation; GVHD
= graft-versus-host disease.