United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — 13th PVRI World Congress 2019
24 slides from United Therapeutics's conference presentation, Feb 1, 2019
Slide 1: Disclosures
The University of Rochester does research with and provides consulting service to United Therapeutics, with all funds to institution. RJW has no personal financial interest in FREEDOM-EV results or United Therapeutics. Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelon
Slide 2: FREEDOM-EV Study Design
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 3 FREEDOM-EV Study Design Primary Efficacy Endpoint Time to the first clinical worsening event NCT01560624 TDE-PH-310 Randomize 1:1 Doubl
Slide 3: Primary Endpoint Definition
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 4 Primary Endpoint Definition Key Clinical Assessments Primary Endpoint Clinical Worsening Event (blindly adjudicated) Death (all causes)
Slide 4: Secondary Endpoints
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 5 Secondary Endpoint Definition Key Clinical Assessments Change from baseline to week 24: 6MWD NT-proBNP Combined 6MWD and Borg dyspnea s
Slide 5: Demographic & Baseline Characteristics
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 6 Demographic & Baseline Characteristics AGE 85% < 65 YRS OLD 79% 15% >65 YRS OLD 21% 47% ASIA & PACIFIC 25.5% SOUTH & LATIN AMERICA GEOG
Slide 6: Demographic & Baseline Characteristics
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 7 Demographic & Baseline Characteristics TIME SINCE DIAGNOSIS BACKGROUND PAH THERAPY 72% PDE-5I OR sGC 28% ERA 6MWD 63% FC II WHO FC 3% F
Slide 7: Median Dose by Visit
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 8 Median Dose by Visit 2.5 (0.125, 10.625) mg 3.5625 (0.125, 12) mg 0 1 2 3 4 5 6 W0 W4 W8 W12 W24 W36 W48 W60 W72 W84 W96 VISIT Oral Tre
Slide 8: Adjudicated Clinical Worsening Events
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 9 Adjudicated Clinical Worsening Events ORAL TREPROSTINIL PLACEBO a Hazard ratio, 95% CI, and P value are calculated with proportional ha
Slide 9: Time to Adjudicated Clinical Worsening
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 10 Time to Adjudicated Clinical Worsening (Weeks) Kaplan–Meier Estimates PATIENTS WITHOUT AN EVENT (%) p= 0.0391a HR: 0.74 (95% CI: 0.56-
Slide 10: Most Commonly Reported Adverse Events
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 11 Most Commonly Reported Adverse Events (By Preferred Term) ORAL TREPROSTINIL N = 346 PLACEBO N = 344 n(%) n(%) Preferred term Any event
Slide 11: Summary of Subject Disposition at Study Closure
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 12 Summary of Subject Disposition at Study Closure Entered Study TDE-PH-310 n=690 Discontinued from Study TDE-PH-310 or -311 n=106 Partic
Slide 12: Summary of Deaths (All Causes) at Study Closure
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 13 Summary of Deaths (All Causes) at Study Closure ORAL TREPROSTINIL PLACEBO a Vital status was collected at closure of Study TDE-PH-310
Slide 13: Summary of Deaths (All Causes)
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 14 Summary of Deaths (All Causes) ORAL TREPROSTINIL PLACEBO a Vital status was collected at closure of Study TDE-PH-310 for all subjects,
Slide 14: Summary of Risk Stratification at Baseline
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 15 Summary of Risk Stratification at Baseline Population: ITT 32.9% 17.7% 28.1% 21.3% 33.2% 25.2% 30.3% 11.3% NUMBER OF LOW-RISK CATEGORI
Slide 15: Summary of Deaths Adjusted by Baseline Risk Stratification
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 16 Summary of Deaths (All Causes) Adjusted by Baseline Risk Stratification a Vital status was collected at closure of Study TDE-PH-310 fo
Slide 16: Summary
The primary efficacy endpoint of delayed time to first clinical worsening was met Disease progression is driving the treatment difference Safety profile was similar to the previous studies and was common to prostacyclin class of therapies Oral treprostinil added on to background PAH monotherapy sign
Slide 17: FREEDOM-EV Investigators
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 18 FREEDOM-EV Investigators Investigator Institution Linda Cadaret Sif Hansdottir (Previous Investigator) University of Iowa Hospitals an
Slide 18: FREEDOM-EV Investigators, Cont.
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 19 FREEDOM-EV Investigators, Cont. Investigator Institution Ralf Ewert Universitatsmedizin Greifswald Klinik und Poliklinik fur Innere Me
Slide 19: FREEDOM-EV Investigators, Cont.
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 20 FREEDOM-EV Investigators, Cont. Investigator Institution Daniel Grinnan Virginia Commonwealth University Medical Center Benjamin Howar
Slide 20: Additional Slides
Additional Slides Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 21
Slide 21: Time to Death at Study Closure
Presented at the 13th PVRI World Congress January 30 – February 05, 2019 Barcelona, Spain Disclosure: This study was sponsored by United Therapeutics Corporation. 22 Time to Death at Study Closure Kaplan–Meier Estimates a P value is calculated with log rank test stratified by background PAH therapy
Slide 22: Summary and Analysis of Disease Progression
Summary and Analysis of Disease Progression 23 ORAL TREPROSTINIL PLACEBO N=346 % N=344 % Number and percentage of subject disease progression All Events 19 5.5% 50 14.5% Decrease in 6MWD >15% and increase in WHO Functional Class 9 2.6% 28 8.1% Decrease in 6MWD >15% and appearance or worsening of sym
Slide 23: Time to Disease Progression (Weeks)
Time to Disease Progression (Weeks) Kaplan–Meier Estimates 24 a P value is calculated with log rank test stratified by background PAH therapy and baseline 6MWD category. b Hazard ratio, 95% CI, and P value are calculated with proportional hazard model with treatment, background PAH therapy and basel
Slide 24: Time to Disease Progression (Weeks)
Time to Disease Progression (Weeks) Kaplan-Meier Estimates Population: ITT 100 ORAL TREPROSTINIL e 75 PLACEBO F H Bn] moome Efe poscrozat, pomie ate WEEKS Pes 2 Manga Fay 5.208 Btn Se Deseo Rinceayeis peendty bance Reepuaompeaion