New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents

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2 New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents William Tyor, M.D. Chief, Neurology Atlanta VA Medical Center Professor, Department of Neurology Emory University School of Medicine

3 Personal/Professional Financial Relationships with Industry None

4 Outline FDA approved oral treatment for MS - fingolimod Oral treatments in advanced trial stages teriflunomide, cladribine, laquinimod and BG 12 Summary

5

6 Inflammation RELATIONSHIP OF DISEASE COURSE AND RESPONSE TO THERAPY Effective? Partially Effective Ineffective Neuronal degeneration

7 FIRST LINE THERAPIES FOR RR MS: Interferon beta 1b (Betaseron) 1993 Interferon beta 1a, IM (Avonex) 1996 Glatiramer acetate (Copaxone) 1998 Interferon beta 1a, subcu (Rebif) 2000 Fingolimod (Gilenya) 2010

8 What Do the BARC Drugs Do? Excluding fingolimod: They are very roughly equivalent in: Reducing relapses by about 30% Reducing MRI lesions Slowing disability Are their favorites?

9 Where will oral agents fit?

10 Fingolimod (Gilenya) Kappos et al. NEJM 2010; 362: month, double-blind, placebo controlled, randomized study involving 1033 patients receiving placebo, 0.5 or 1.25 mg of fingolimod

11 Fingolimod Significantly Reduced the Risk of Confirmed Disability Progression at 24 Months Patients with EDSS progression confirmed after 3 months (%) Patients with EDSS progression confirmed after 6 months (%) P < 0.05 for fingolimod versus placebo Placebo Fingolimod 0.5 mg P < 0.05 for fingolimod versus placebo 24.1% 17.7% Placebo Fingolimod 0.5 mg 19.0% 12.5% Kaplan Meier estimate of time to progression (days) Key Secondary Endpoint: 30% reduction in 3-month confirmed risk of progression (hazard ratio: 0.70; 95% CI: ; P < 0.05) b Secondary Endpoint: 37% reduction in 6-month confirmed risk of progression (hazard ratio: 0.63; 95% CI: ; P < 0.05) b 1. Kappos et al., N Engl J Med. 2010;362(5): Bandiwala SI, Munoz SR. Elsevier Science B.V; 2002: Data on File

12 Fingolimod (Gilenya) Cohen et al. NEJM 2010; 362: month, double blind, randomized, double dummy study with 1292 RR MS patients given either 1.25 mg or 0.5 mg fingolimod or interferon-beta 1a (Avonex) Annualized RR lower in both fingolimod groups (0.2 and 0.16 respectively vs 0.33; p<0.001) MRI (new T2 lesions) supported these results

13 Mean change in EDSS score from baseline Mean change in MSFC z- score from baseline Fingolimod Improved Both The EDSS And MSFC Score at 1 Year Compared With Interferon Beta-1a IM Main Menu Change in EDSS (Secondary Endpoint) Change in MSFC (Secondary Endpoint) IFNβ-1a IM Fingolimod 0.5 mg Deterioration Improvement (N = 394) (N = 377) 0 (N = 366) (N = 383) Improvement Deterioration IFNβ-1a IM Fingolimod 0.5 mg P= 0.06 for fingolimod versus IFNβ-1a IM (not significant) P = 0.02 for fingolimod versus IFNβ-1a IM Cohen et al., N Engl J Med. 2010;362(5):

14 Fingolimod Adverse Events and Monitoring Patient with pre-existing cardiac conditions such as ischemic heart dx, CHF, and cardiac dysrthymias should either be steered away from drug or undergo cardiology consult Must obtain ECG before start of medication and at the end of the 6 hour period of monitoring after the first dose Cardiac problems tend to be more common with the higher dose [bradycardia and/or elevated BP after 1 st dose] and the lower dose 0.5 mg q day is now marketed Depending on the patient, BP and HR are monitored q hour some experts are recommending telemetry with or without admission for up to 24 hrs Cases of transient heart block seen on ECG also only at the start of Rx

15 Quick Overview of Mortality (as of January 2012) More than 30,000 patients treated since Deaths of Potential Interest 3 complications of advanced MS 3 MIs 2 drownings 2 unexplained deaths during sleep 1 hypertensive cardiovascular dx 20 Other Cases 6 suicides 5 off drug at time of death 4 progression of MS 2 infections 1 traffic accident 2 others Currently under review by the FDA and EMA

16 Fingolimod Adverse Events and Monitoring Macular edema (ME) can rarely occur (2 patients in the 0.5 mg qday groups) - recommendations for pre-ophthalmology screening and 3-4 months after start Hx of DM or uveitis should at least prompt continued monitoring (after 3 months) In most cases ME improves or resolves after drug cessation See Jain N and Bhatti MT. Fingolimod-associated macular edema. Neurology : 672

17 Fingolimod Adverse Events and Monitoring WBC counts often are reduced somewhat and liver enzymes occasionally elevated, probably necessitating monitoring these although this is not a formal recommendation Infections are slightly more common such as respiratory and UTI and it is also possible that Herpes infections (genital) are more common Definitely need to have antibody to varicella zoster either by previous chicken pox or vaccination Skin cancers (e.g., basal cell) may be more common

18 Summary for Fingolimod Highly efficacious oral therapy for relapsing MS Overall it is safe, but there are extra considerations and measures that need to be taken to insure its safe administration Is it a first line therapy for relapsing MS? I think so [for most patients], but discussion is welcome.

19 FUTURE THERAPIES ONLY A FEW: Cladribine Laquinimod Teriflunomide BG12

20 Oral Cladribine Phase III Trial The primary end point was the rate of relapse at 96 weeks (A) Also significant reductions in Time to first relapse (B), Cumulative # of relapses (C), and Time to progression/ EDSS (D)

21 Oral Cladribine Phase III Trial Significant (p<0.001) MRI reductions in: T2 lesions 1.43 with placebo, 0.38 with 3.5 mg/kg and with 5.25 mg/kg dose Enhancing lesions 0.91 in placebo, 0.12 with 3.5 dose and 0.11 with 5.25 dose Combined unique lesions 1.72 placebo, 0.43 in 3.5 dose and 0.38 in 5.25 dose

22 Cladribine Adverse Events Mild to moderate lymphocytopenia seen in 28% and severe neutropenia in 3 patients and overall leading to discontinuation of drug in about 5% Mild to moderate infections were slightly more common including zoster Rare cases of cancer can occur

23 Ongoing Studies? Two year extension of the CLARITY study ONWARD is ongoing to investigate adding two different dosages of cladribine to interferonbeta (recruiting 260 RR MS patients) ORACLE is ongoing to study safety and effectiveness in 642 patients with CIS However

24 Latest Update on Licensing Turned down by both the FDA and EMA primarily due to the risk of cancer (4 cases) In June 2011 Merck withdrew its applications for licensing Cladribine is currently marketed for hairy cell leukemia

Laquinimod Polman, C. et al. Neurology 2005;64:987-991

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