{"id":49947,"date":"2022-10-22T21:03:07","date_gmt":"2022-10-22T19:03:07","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/mercks-prevymis-demonstrates-efficacy-in-phase-3-study-for-prevention-of-cytomegalovirus-disease-in-adults-after-kidney-transplantation\/"},"modified":"2022-10-22T21:03:07","modified_gmt":"2022-10-22T19:03:07","slug":"mercks-prevymis-demonstrates-efficacy-in-phase-3-study-for-prevention-of-cytomegalovirus-disease-in-adults-after-kidney-transplantation","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/mercks-prevymis-demonstrates-efficacy-in-phase-3-study-for-prevention-of-cytomegalovirus-disease-in-adults-after-kidney-transplantation\/","title":{"rendered":"Merck\u2019s PREVYMIS\u2122 Demonstrates Efficacy in Phase 3 Study for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation"},"content":{"rendered":"
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\nPREVYMIS showed non-inferior efficacy and more favorable safety profile compared to standard of care; results presented at IDWeek 2022<\/b>\n<\/p>\n

\nSeparate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint<\/b>\n<\/p>\n

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK<\/a> #MRK<\/a>–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the presentation of findings from a Phase 3 clinical trial that assessed safety and efficacy of PREVYMIS\u2122 (letermovir) compared to valganciclovir for cytomegalovirus (CMV) prophylaxis in 601 adult kidney transplant recipients at high risk for CMV disease (D+\/R-). At 52 weeks following kidney transplant, trial results met the primary endpoint demonstrating that PREVYMIS was effective and non-inferior to valganciclovir for preventing CMV disease — 10.4% (n=30) of participants who received PREVYMIS developed CMV disease versus 11.8% (n=35) of participants on valganciclovir (stratum adjusted difference = -1.4, [95% CI, -6.5, 3.8]). In a pre-specified safety analysis, PREVYMIS-treated participants had significantly less myelotoxicity, as measured by rates of leukopenia or neutropenia, compared to valganciclovir-treated participants; 26.0% (n=76) versus 64.0% (n=190), (95% CI, -45.1, -30.3; p-value <0.0001). The findings from this trial were presented during a late-breaking oral session at the IDWeek Annual Meeting<\/a> (Abstract # LB2307). Merck plans to submit a supplemental new drug application (sNDA) with these data to the U.S. Food and Drug Administration (FDA) by the end of this year.\n<\/p>\n

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\nPREVYMIS is a first-in-class antiviral agent that was approved by the U.S. FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations may lead to ergotism. PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.\n<\/p>\n

\n\u201cCMV disease is an important cause of morbidity and mortality in kidney transplant recipients. Valganciclovir has been the most commonly used drug for CMV prophylaxis in this setting, but myelotoxicity (especially neutropenia and leukopenia) is an important limitation of this drug. Myelotoxicities can be difficult to manage in patients who are already receiving complex treatment regimens with other drugs that also have bone marrow suppressive effects,\u201d said Dr. Ajit P. Limaye, director, Solid Organ Transplant Infectious Disease Program at University of Washington School of Medicine. \u201cI was excited to see these trial results that showed that the efficacy of PREVYMIS for prevention of CMV disease in kidney transplant patients was similar to the current standard of care treatment (valganciclovir), but with significantly less toxicity.\u201d\n<\/p>\n

\n\u201cThere is a need for additional CMV prophylactic options for kidney transplant recipients to help patients reduce risk of opportunistic infections,\u201d said Dr. Nicholas Kartsonis, senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories. \u201cThese new study results in adult kidney transplant patients are encouraging and demonstrate the potential of PREVYMIS to prevent CMV disease with a therapy that showed lower rates of neutropenia and leukopenia versus the comparator.\u201d\n<\/p>\n

\nAbout the Phase 3 trial and efficacy results for PREVYMIS in kidney transplant recipients<\/b>\n<\/p>\n

\nThe objective of this Phase 3, randomized, double-blind, non-inferiority trial was to evaluate PREVYMIS versus valganciclovir in preventing CMV disease in adult kidney transplant recipients at high risk for CMV disease. In the trial, 601 participants were randomized (1:1) to receive either 480 mg of PREVYMIS once a day (n=301) or 900 mg of valganciclovir once a day (n=300) within 7 days post-kidney transplant through 28 weeks (~200 days) post-transplant, with follow-up through 52 weeks. The primary endpoint was the proportion of participants with CMV disease adjudicated by an independent committee that was blinded to treatment assignment through Week 52 post-kidney transplant. The median age of participants was 52 years in the PREVYMIS study group and 51 years in the valganciclovir study group. Participants were stratified by use\/non-use of lymphocyte-depleting induction immunotherapy.\n<\/p>\n

\nAt 52 weeks following transplant, 10.4% (n=30) of the PREVYMIS group had CMV disease versus 11.8% (n=35) of the valganciclovir group (stratum adjusted difference = -1.4, [95% CI, -6.5, 3.8]), meeting non-inferiority for the trial\u2019s primary endpoint. Efficacy was comparable across all subgroups (age, gender, race and geography). For the secondary endpoint of adjudicated CMV disease at 28 weeks following transplant, 0% (n=0) of PREVYMIS participants and 1.7% (n=5) of valganciclovir participants had CMV disease (stratum adjusted difference = -1.7 [95% CI, -3.4, 0.1]).\n<\/p>\n

\nKey safety results<\/b>\n<\/p>\n

\nPREVYMIS had a more favorable safety profile compared to valganciclovir, with fewer drug-related adverse events and study drug discontinuations due to adverse events reported in the PREVYMIS group compared to the valganciclovir group. The incidence of leukopenia (decrease in leukocytes, or white blood cells) and neutropenia (decrease in of neutrophils, the most common type of white blood cell) was lower with PREVYMIS than with valganciclovir:\n<\/p>\n