Interim Data of Adcetris in Pediatric Patients Presented at ASCO Meeting

At a poster presentation at the American Society of Clinical Oncology meeting, Takeda Pharmaceutical Company Limited presented interim data from a Phase 1/2, open-label, multicenter study of the antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in pediatric patients diagnosed with either CD30-positive relapsed or refractory Hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

Data was only presented from the Phase 1 part of the study. This phase evaluated the safety and maximum tolerated dose, and is the first clinical trial looking at Adcetris in pediatric patients. 

Said Kathleen Neville, M.D., M.S., Director, Experimental Therapeutics in Pediatric Cancer, Children’s Mercy Hospitals and Clinics, Kansas City, Mo.:

There is an unmet medical need for children diagnosed with relapsed or refractory HL or relapsed or refractory sALCL. We are encouraged by these early results and look forward to reporting data from the Phase 2 portion of the study when they are available.

The data were presented by Anna R.K. Franklin, M.D., Children's Cancer Hospital, MD Anderson Cancer Center, Houston, Texas. The study involved just 12 patients between 2 and 18 (median age: 14.5 years) diagnosed with relapsed or refractory HL (10 patients) or relapsed or refractory sALCL (two patients) with primary endpoints set at safety and pediatric maximum tolerated dose. 

Treatment-emergent adverse events (TEAEs) ≥ Grade 2 were nausea (eight patients), pyrexia (six patients), upper abdominal pain (four patients) and paresthesia (four patients).

Seven serious AEs (SAEs) of ≥ Grade 3 were reported in six patients (50 percent) at 1.8 mg/kg (which was determined to be the maximum tolerated dose), including pyrexia unrelated to treatment (one patient), hepatotoxicity and febrile neutropenia (one patient), anaphylactic reaction (one patient), supraventricular tachycardia unrelated to treatment (one patient), pain in extremity (one patient), and cardiac arrest resulting in death unrelated to treatment (one patient).

Secondary endpoints of overall response rate (ORR) and complete response rate (CR) were available for eight patients and were reported as 88 percent and 38 percent respectively.

Source: ASCO 2013