Classic Hodgkin's lymphoma (cHL) new drug! Mercadon Keytruda was reviewed by the FDA as a priority, and the efficacy beats Adcetris!

, July 10, 2020 /
PRNewswire/ -- The U.SFood and Drug Administration (FDA) has accepted a new supplemental biologics licensing application (sBLA) for anti-PD-1 therapy Keytruda (Corrida, generic name: pemzumalib, Paboli Zhusinga) The sBLA seeks approval for Keytruda as a single drug therapy for second-line treatment of patients with recurrent or refractive classic Hodgkin's lymphoma (r/r cHL)FDAhas designated the sBLA's Prescription Drug User Charges (PDUFA) target date as October 30, 2020this sBLA is based on the results of the head-to-head critical PHASE III KEYNOTE-204 test (NCT02684292)The data showed that in r/r cHL adult patients, Keytruda significantly reduced the risk of disease progression or death by 35% and significantly extended the risk of progression or death (PFS) compared to the standard care drug Adcetris (brentuximab vedotin), and significantly extended the survival of progressionless (PFS) (median PFS: 13.2 months vs 8.3 months)these data are particularly significant because about 15% to 20% of cHL (the most common Hodgkin's lymphoma type) patients do not usually receive relief after first-line treatmentThese patients are generally young and, if not alleviated, the prognosis is very poorData from the KEYNOTE-204 trial show that Keytruda single drug therapy has the potential to change the current treatment patterns in cHL patientsclassic Hodgkin's lymphoma (cHL, picture: atlasgeneticsoncology.org)Adcetris (Chinese product name: Amsley, injection vibutuxib monotoma), is a targeted CD30 antibody drug conjugate (ADC) developed by Takeda Pharmaceuticals and SeattleGenetics, a standard care drug for the treatment of r/r cHLIn China, Adcetris (Astly) was officially approved by the National Drug Administration (NMPA) in mid-May to treat patients with recurrent or refractive systemic interstituatoral large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma (HL)(See: redefine lymphoma treatment!) Takeda antibody drug conjugate (ADC) Adcetris (Amsley, Vibutuximonoditis) has been officially approved by China! ) it is worth mentioning that KEYNOTE-204 is the first Phase III trial to evaluate positive results for an anti-PD-1 therapy treatment r/r cHL In March 2017, the U.S FDA accelerated approval of Keytruda for the treatment of patients with refractive cHL adults and children, or cHL patients who have previously received three or three forms of relapse The accelerated approval is based on the tumor mitigation rate and mitigation persistence data based on the Phase II KEYNOTE-087 trial In addition to supporting the sBLA, the KEYNOTE-204 trial will also serve as a validation trial for Keytruda's accelerated approval of hematology indications "CHL accounts for more than 90 percent of Hodgkin's lymphoma (HL) cases, and about 7,400 patients in the United States are affected by the disease each year," said Dr Jonathan Cheng, deputy director of clinical research in oncology at the Mersadon Research Laboratory For cHL patients whose condition has not been alleviated after first-line treatment, the prognosis is particularly poor due to limited options We look forward to working with FDA to bring Keytruda to more cHL patients who have received initial treatment "
keynote-204 is a randomized, open-label, head-to-head Phase III trial that evaluated the efficacy and safety of Keytruda monodrug therapy and BV treatment r/r cHL The trial included 304 adult patients aged 18 and older who were randomly assigned to receive Keytruda (200mg intravenous infusion, one cycle per 3 weeks, 35 cycles per cycle) or BV (1.8 mg/kg (maximum dose of 180 mg) on the 1st day of each cycle, one for each 3 weeks, 35 cycles of treatment The common primary endpoints of the experiment were Progressless Survival (PFS) and Total Lifetime (OS), and key secondary endpoints included Objective Mitigation Rate (ORR), Total Mitigation Rate (CR), and Safety results show that the study reached one of the two major endpoints of the progression-free survival (PFS) According to a mid-term analysis conducted by the Independent Data Monitoring Board (DMC), the Keytruda treatment group achieved statistically significant and clinical improvements in PFS in this patient group compared to the BV treatment group The specific data were: The risk of disease progression or death in the Keytruda group decreased significantly by 35% compared to the BV group (HR-0.65 (95% CI:0.48-0.88), p-0.00271), PFS significantly extended (median PFS: 13.2 months vs 8.3 months), and one-year progression-free survival rate increased (53.9% 35.6%) In addition, the ORR in keytruda group was 65.6%, the BV group was 35.6%, the Keytruda group partial mitigation rate (PR) was 41.1% and the BV group was 30.1% The bit mitigation duration (DOR) in the Keytruda group was 20.7 months (range: 0.0 to 33.2 plus), and the BV group was 13.8% (range: 0.0 to 33.9 plus) , based on a pre-specified analysis plan, did not formally test another common primary endpoint, the OS, in this interim analysis The study will continue to evaluate OS In terms of safety, the incidence of therapeutic-related adverse events (TRAE) was similar to that of keytruda group (74.3%) and BV group (77.0%) Level 3-5 TRAE incidence, Keytruda group (19.6%) lower than THE BV group (25.0%) One treatment-related death (pneumonia) occurred in the Keytruda group (BioValleyBioon.com) original source: FDA Grants Priority Review to Merck's Supplemental Biologics License Application for KEYTRUDA ® (pembrolib) for Second-Line Treatment of Patients with Relapsed or Refracto Classical Hodg Ly
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