Pembrolizumab (Keytruda) received an accelerated approval for adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after at least 3 lines of therapy.
Merck has announced that its programmed death-1 inhibitor, pembrolizumab (Keytruda), has been approved for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL) or those who have relapsed after at least 3 lines of therapy. This is an accelerated approval for the drug—proved clinical benefit from confirmatory trials will ensure continued approval.
The approval was based on results from the Keynote-087 trial, which recruited 210 patients with relapsed/refractory cHL, who:
The primary trial outcomes being measured included overall response rate (ORR), percentage of participants with at least 1 adverse event (AE), and percentage of participants discontinuing their study due to adverse events. Secondary outcomes were complete response rate (CRR), progression-free survival, duration of response, and overall survival.
At a median follow-up of 9.4 months, ORR was 69% (95% CI, 62—75) with 200 mg pembrolizumab administered every 3 weeks. CRR was 22% and the partial remission rate was 47%. Of the 145 patients who responded to treatment, the median duration of response was 11.1 months.
Only 5% of patients discontinued treatment due to AEs, but treatment was interrupted in another 26% due to AEs. Most frequent serious AEs, observed in 16% of patients, included pneumonia, pneumonitis, pyrexia, dyspnea, graft-versus-host disease (GVHD), and herpes zoster. Of 2 patients who died from causes other than disease progression, 1 died from GVHD and the other from septic shock.
The pediatric approval comes from data extrapolated from a pediatric melanoma trial.
Survey Results Reveal Potential Factors Slowing the Decline in Cardiovascular Mortality Rate
April 23rd 2024Research indicated that worsened glycemic, blood pressure, and obesity control, as well as increased alcohol consumption, leveled lipid control, and persistent socioeconomic disparities may have contributed to the decelerated cardiovascular mortality decline in recent years.
Read More
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Patient-Reported Outcomes Help to Uncover Frailty Patterns in Those With Acute COPD Exacerbations
April 22nd 2024Study findings demonstrate the pivotal role of patient-reported outcomes in identifying frailty among individuals experiencing acute exacerbations of chronic obstructive pulmonary disease (COPD).
Read More