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The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL).
The indication also includes patients who have relapsed after 2 or more prior lines of therapy.
Pembrolizumab had received priority review for PMBCL late last year and also has orphan drug designation and breakthrough therapy designation for this indication.
The FDA based its approval on data from the KEYNOTE-170 (NCT02576990 ) trial.
Investigators enrolled 53 patients onto the multicenter, open-label, single-arm trial. Patients received pembrolizumab 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression.
Patients whose disease did not progress received the drug for up to 24 months.
Patient characteristics
Patients were a median age of 33 years (range, 20 – 61), 43% were male, 92% white, 43% had an ECOG performance status of 0, and 57% had an ECOG performance status of 1.
Almost half (49%) had relapsed disease, and 36% had primary refractory disease.
About a quarter (26%) had undergone prior autologous hematopoietic stem cell transplant, and 32% had prior radiation therapy.
All patients had received prior rituximab.
Results
At a median follow-up of 9.7 months, the overall response rate was 45% (24 responders), including 11% complete responses and 34% partial responses.
The median duration of response was not reached during the follow-up period and ranged from a median 1.1 to 19.2 months.
Median time to first objective response was 2.8 months (range, 2.1 – 8.5). Accordingly, investigators do not recommend pembrolizumab for PMBCL patients who require urgent cytoreductive therapy.
Safety
The most common adverse events occurring in 10% or more of patients were musculoskeletal pain (30%), upper respiratory tract infection (28%), pyrexia (28%), fatigue (23%), cough (26%), dyspnea (21%), diarrhea (13%), abdominal pain (13%), nausea (11%), arrhythmia (11%), and headache (11%).
Eight percent of patients discontinued treatment, and 15% interrupted treatment due to adverse reactions.
Adverse events requiring systemic corticosteroid therapy occurred in 25% of patients.
Serious adverse events occurred in 26% and included arrhythmia (4 %), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%).
Six (11%) patients died within 30 days of start of treatment.
The recommended pembrolizumab dose for treatment of adults with PMBCL is 200 mg every 3 weeks. The recommended dose in pediatric patients is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks.
Additional indications for pembrolizumab include melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.
The full prescribing information is available on the FDA website.
Pembrolizumab (Keytruda) is a product of Merck & Co, Inc.
The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL).
The indication also includes patients who have relapsed after 2 or more prior lines of therapy.
Pembrolizumab had received priority review for PMBCL late last year and also has orphan drug designation and breakthrough therapy designation for this indication.
The FDA based its approval on data from the KEYNOTE-170 (NCT02576990 ) trial.
Investigators enrolled 53 patients onto the multicenter, open-label, single-arm trial. Patients received pembrolizumab 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression.
Patients whose disease did not progress received the drug for up to 24 months.
Patient characteristics
Patients were a median age of 33 years (range, 20 – 61), 43% were male, 92% white, 43% had an ECOG performance status of 0, and 57% had an ECOG performance status of 1.
Almost half (49%) had relapsed disease, and 36% had primary refractory disease.
About a quarter (26%) had undergone prior autologous hematopoietic stem cell transplant, and 32% had prior radiation therapy.
All patients had received prior rituximab.
Results
At a median follow-up of 9.7 months, the overall response rate was 45% (24 responders), including 11% complete responses and 34% partial responses.
The median duration of response was not reached during the follow-up period and ranged from a median 1.1 to 19.2 months.
Median time to first objective response was 2.8 months (range, 2.1 – 8.5). Accordingly, investigators do not recommend pembrolizumab for PMBCL patients who require urgent cytoreductive therapy.
Safety
The most common adverse events occurring in 10% or more of patients were musculoskeletal pain (30%), upper respiratory tract infection (28%), pyrexia (28%), fatigue (23%), cough (26%), dyspnea (21%), diarrhea (13%), abdominal pain (13%), nausea (11%), arrhythmia (11%), and headache (11%).
Eight percent of patients discontinued treatment, and 15% interrupted treatment due to adverse reactions.
Adverse events requiring systemic corticosteroid therapy occurred in 25% of patients.
Serious adverse events occurred in 26% and included arrhythmia (4 %), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%).
Six (11%) patients died within 30 days of start of treatment.
The recommended pembrolizumab dose for treatment of adults with PMBCL is 200 mg every 3 weeks. The recommended dose in pediatric patients is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks.
Additional indications for pembrolizumab include melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.
The full prescribing information is available on the FDA website.
Pembrolizumab (Keytruda) is a product of Merck & Co, Inc.
The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL).
The indication also includes patients who have relapsed after 2 or more prior lines of therapy.
Pembrolizumab had received priority review for PMBCL late last year and also has orphan drug designation and breakthrough therapy designation for this indication.
The FDA based its approval on data from the KEYNOTE-170 (NCT02576990 ) trial.
Investigators enrolled 53 patients onto the multicenter, open-label, single-arm trial. Patients received pembrolizumab 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression.
Patients whose disease did not progress received the drug for up to 24 months.
Patient characteristics
Patients were a median age of 33 years (range, 20 – 61), 43% were male, 92% white, 43% had an ECOG performance status of 0, and 57% had an ECOG performance status of 1.
Almost half (49%) had relapsed disease, and 36% had primary refractory disease.
About a quarter (26%) had undergone prior autologous hematopoietic stem cell transplant, and 32% had prior radiation therapy.
All patients had received prior rituximab.
Results
At a median follow-up of 9.7 months, the overall response rate was 45% (24 responders), including 11% complete responses and 34% partial responses.
The median duration of response was not reached during the follow-up period and ranged from a median 1.1 to 19.2 months.
Median time to first objective response was 2.8 months (range, 2.1 – 8.5). Accordingly, investigators do not recommend pembrolizumab for PMBCL patients who require urgent cytoreductive therapy.
Safety
The most common adverse events occurring in 10% or more of patients were musculoskeletal pain (30%), upper respiratory tract infection (28%), pyrexia (28%), fatigue (23%), cough (26%), dyspnea (21%), diarrhea (13%), abdominal pain (13%), nausea (11%), arrhythmia (11%), and headache (11%).
Eight percent of patients discontinued treatment, and 15% interrupted treatment due to adverse reactions.
Adverse events requiring systemic corticosteroid therapy occurred in 25% of patients.
Serious adverse events occurred in 26% and included arrhythmia (4 %), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%).
Six (11%) patients died within 30 days of start of treatment.
The recommended pembrolizumab dose for treatment of adults with PMBCL is 200 mg every 3 weeks. The recommended dose in pediatric patients is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks.
Additional indications for pembrolizumab include melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.
The full prescribing information is available on the FDA website.
Pembrolizumab (Keytruda) is a product of Merck & Co, Inc.