Keytruda Tops Adcetris in Head-to-Head Hodgkin’s Trial

Pembrolizumab (Keytruda) vastly improved development-free survival (PFS) over brentuximab vedotin (Adcetris) for Hodgkin’s lymphoma sufferers who failed on or were ineligible for transplant, findings from KEYNOTE-204 confirmed.

Among the 300 sufferers within the phase III trial, median PFS on blinded central review reached 13.2 months with the PD-1 immune checkpoint inhibitor pembrolizumab, as compared with 8.3 months with brentuximab vedotin, an antibody-drug conjugate (HR 0.65, 95% CI 0.48-0.88, P=0.0027), reported Pier Luigi Zinzani, MD, PhD, of the College of Bologna in Italy.

This almost about 5-month PFS support changed into “clinically meaningful,” said Zinzani, and extended to key groups, including these with major refractory illness (HR 0.52, 95% CI 0.33-0.83) and sufferers naive to autologous stem cell transplant (HR 0.61, 95% CI 0.42-0.89). Sufferers without prior exposure to brentuximab vedotin furthermore had vastly improved PFS with pembrolizumab (HR 0.67, 95% CI 0.49-0.92).

“Pembrolizumab needs to be conception of as primarily the most well-most accepted treatment option and new same previous of take care of the treatment of relapsed and refractory classical Hodgkin lymphoma in sufferers who relapsed after auto stem cell transplant or are ineligible for auto stem cell transplant,” Zinzani said eventually of a presentation for the media at the digital meeting of the European Hematology Affiliation.

Response charges were furthermore improved with pembrolizumab when compared with brentuximab vedotin (65.6% vs 54.2%, P=0.0225), driven by extra partial responses (41.1% vs 30.1%). Median periods of response were 20.7 and 13.8 months, respectively.

Well-liked treatment for sufferers with relapsed or refractory classical Hodgkin’s lymphoma has consisted of salvage chemotherapy and autologous stem cell transplantation, Zinzani outlined, but no same previous of care exists for these ineligible for transplant due to major chemorefractory illness, age, or comorbidities.

KEYNOTE-204 changed into an launch-ticket phase III trial that randomized 300 sufferers to 200-mg pembrolizumab or 1.8-mg/kg brentuximab vedotin, with each and each delivered intravenously every 3 weeks for up to 35 cycles. Median affected person age changed into 36 and 35 years within the two fingers, respectively. About 40% of sufferers in every arm had major refractory illness, and 28% had relapsed within 12 months of their previous treatment.

Eligible sufferers had illness development following prior autologous stem cell transplant (37%) or can also no longer endure transplant due to comorbidities, age, or other factors (63%). Sufferers were required to consider perfect performance station (Eastern Cooperative Oncology Community 0-1). Prior brentuximab vedotin, while allowed within the learn about, changed into rare at 3.3% within the pembrolizumab arm and 6.5% within the brentuximab vedotin arm.

Grade 3 or better antagonistic events (AEs) were comparable between the two fingers (43.9% with pembrolizumab and 43.4% with brentuximab vedotin). Whereas excessive AEs were elevated with pembrolizumab (29.7% vs 21.1%), a slightly better proportion stopped treatment for toxicity on the brentuximab vedotin arm (17.8% vs 13.5%).

Total, almost about all sufferers experienced AEs no topic treatment, and events were in line with the identified security profiles of the two treatment, said Zinzani. Pembrolizumab changed into associated to better charges of hypothyroidism (15.5% vs 1.3% with brentuximab vedotin), pyrexia (12.8% vs 5.9%), and pruritis (10.8% vs 5.3%). Brentuximab vedotin, on the different hand, changed into associated to extra peripheral neuropathy (18.4% vs 2.0% with pembrolizumab), peripheral sensory neuropathy (13.2% vs 2.0%), nausea (13.2% vs 4.1%), and fatigue (10.5% vs 8.8%).