Bayer Presents Five-Year Outcomes Data from the PROTECT VIII Extension Study at the 60th American Society of Hematology Annual Meeting

WHIPPANY, N.J., Dec. 4, 2018 /PRNewswire/ -- Bayer announced findings from an analysis of the PROTECT VIII extension in which patients who received five years of prophylactic treatment with Jivi ® (BAY 94-9027, antihemophilic factor [recombinant] PEGylated-aucl), maintained a safety and efficacy profile that was consistent with prior analysis of the pivotal Phase III PROTECT VIII main study. These data were presented at the Scientific Sessions of the 60^th American Society of Hematology (ASH) annual meeting and Exposition in San Diego, CA.

“These findings provide insight into the long-term efficacy and safety of Jivi in previously treated hemophilia A patients 12 years and older,” said Mark Reding, M.D., associate professor of medicine at the University of Minnesota and lead investigator of the PROTECT VIII study. “This additional information can be instrumental for clinical decision-making and disease management regarding the long term treatment of hemophilia A.”

The PROTECT VIII main study was a partially randomized, open-label trial of 134 males aged 12–65 years with severe hemophilia A. Prophylaxis patients received Jivi (BAY 94-9027) 25 IU/kg twice weekly for a 10-week run-in period. Patients with ≤ 1 spontaneous, joint or muscle bleed during this period were randomized to 45–60 IU/kg every 5 days (Q5D) or 60 IU/kg every 7 days (Q7D) for the main 26-week period, patients enrolling after the randomization arms were full, or with ≥ 2 bleeds in the run-in period, received 30–40 IU/kg twice-weekly (2×W). Treatment success in the every 7-day arm was not established. Twenty patients received Jivi on demand as they had been receiving on-demand FVIII treatment prior to study entry.¹

Following completion of the PROTECT VIII main study, patients could enter an optional extension, continuing Jivi on any regimen used in the main study. Of the 126 patients who completed the main study, 121 entered the extension, of which 107 continued prophylaxis with Jivi. The data presented were from 33 patients who have completed five years of treatment with Jivi at the time of this analysis. Annualized bleeding rate (ABR) and joint ABR were analyzed, along with safety outcomes.

Study data found the previously demonstrated efficacy of Jivi in the main PROTECT VIII study was maintained for a median (range) follow-up period of 3.9 years (0.8-5.4) with a data cut-off date of January 2018. In the last year of the extension study, one third of patients were entirely free from bleeds. Consistent with prior analyses of PROTECT VIII, there were few study drug-related AE and no evidence of any long-term toxicity of PEGylated product exposure. Drug-related adverse events (AE)s occurred in 6 of the 33 patients (18.2%) and none of these patients had a study drug-related serious AE. There were no discontinuations for AEs. No patients had confirmed FVIII inhibitors (titer ≥0.6 Bethesda units). ^1,2

The U.S. Food Drug Administration (FDA) based its recent approval of Jivi on results from the PROTECT VIII main study³ comprised of prophylactic dosing, on-demand treatment and perioperative management in previously treated adults and adolescents 12 years of age and older with severe hemophilia A.

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Jivi Indications and Important Safety Information

INDICATIONS

• Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
• Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
• Jivi is not for use in children below 12 years of age or in previously untreated patients.
• Jivi is not used to treat von Willebrand disease.

IMPORTANT SAFETY INFORMATION

• You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.
• Tell your healthcare provider about all of your medical conditions that you have or had.
• Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.
• Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea.
• Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.
• Your body can also make antibodies, called “inhibitors,” against Jivi, which may stop Jivi from working properly. Consult your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
• If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.
• The common side effects of Jivi are headache, cough, nausea, and fever.
• These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does not go away.

For additional important risk and use information, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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1. Efficacy and Safety of BAY 94-9027 is Sustained for 5 Years: Outcomes in 33 Patients in the PROTECT VIII Extension Study: Mark Reding, Lone Poulsen, Tian Liu, Pal Andre Holme; poster presentation at Scientific Sessions of the American Society of Hematology annual meeting 2018.
2. DOF-CSR Extension Study. Whippany, NJ: Bayer; 2018
3. Jivi [prescribing information]. Whippany, NJ: Bayer; 2018

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