For Health Care Professionals Outside the US

 
 
 

PANORAMA 1: a large phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma1

A phase 3 study of 768 adult patients who had received 1 to 3 lines of prior therapy1

The approval of FARYDAK was based upon the efficacy and safety in a subgroup analysis of 147 patients who had received at least 2 prior regimens, including bortezomib (BTZ) and an immunomodulatory drug (IMiD).

PANORAMA 1 study design1,2

Randomised, double-blind, placebo-controlled, phase 3 study (N=768)

  • Studied in 215 centres in 34 countries2
  • The standard of care at the time of trial execution was twice-weekly IV BTZ plus oral dex2
  • No cross-over was allowed in study groups2
  • Primary end point: progression-free survival1,‡
  • Selected secondary end points: overall survival, complete response/near complete response (CR/nCR) rate,§ time to response, time to progression, duration of response, and safety2

*Patients had measurable disease at screening, defined by serum M protein of ≥1 g/dL or urine M protein of ≥200 mg/24 h. BTZ-refractory patients were excluded.3
FARYDAK 20 mg was taken once a day, 3 times per week on a 2-weeks-on, 1-week-off dosing regimen, in combination with BTZ 1.3 mg/m2 IV and dex 20 mg.2
As per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.1
§CR was defined as absence of M protein in serum and urine by immunofixation for ≥6 weeks, <5% plasma cells in bone marrow, no increase in size or number of lytic bone lesions from baseline, and disappearance of soft tissue plasmacytomas (if present at baseline). All CR criteria apply to nCR, except that absence of serum and urine M protein cannot be confirmed by immunofixation.3

References:

  1. FARYDAK® (panobinostat). EU Summary of Product Characteristics. Novartis AG; April 2016.
  2. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014;15(11):1195-1206.
  3. Kröger N. The European Group for Blood and Marrow Transplantation: multiple myeloma. https://www.ebmt.org/Contents/Resources/Library/Slidebank/Documents/EBMT%202009%20SC%20Slide%20Bank/1211.pdf. Accessed July 22, 2015.

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