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.
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
Read More
Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.
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
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Read More