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Feb 02, 2021, 09:00 ET
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LAS VEGAS, Feb. 2, 2021 /PRNewswire/ — Secura Bio, Inc. ("SBI") – (www.securabio.com), an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announces the publication of new data confirming the efficacy of the approved dose/schedule of FARYDAK^® and demonstrating a considerably improved safety profile for FARYDAK in combination with subcutaneous ("SC") bortezomib (as opposed to intravenous administration) and oral dexamethasone. 
Panobinostat ("Pano"), an oral pan-histone deacetylase inhibitor, is approved for the treatment of relapsed or relapsed/refractory multiple myeloma in combination with bortezomib (Velcade^®) and dexamethasone in patients who have received ≥2 prior lines of therapy, including bortezomib and an immunomodulatory agent ("IMiD"). The original registrational trial, PANORAMA-1, used intravenous ("IV") bortezomib, and demonstrated a significant progression-free survival benefit with FARYDAK / bortezomib / dexamethasone (FVd) as compared with placebo / bortezomib / dexamethasone (Vd); adverse events ("AEs") were expectedly reported as being more frequent with FVd (San-Miguel J. et al., Lancet Oncol. 20). A new study, PANORAMA-3, was undertaken to optimize FVd dosing by investigating three different Pano regimens with SC bortezomib (and oral dexamethasone).
In an oral poster presentation at the American Society of Hematology and in a subsequent publication in Lancet Oncology, results were reported for PANORAMA-3: Efficacy and Safety of the FVd combination in Relapsed or Relapsed/Refractory Multiple Myeloma. This study was a randomized, open-label, international, multicenter phase 2 study.
Eligible patients were ≥18 years old with 1‒4 prior lines of therapy, including an IMiD. Patients primarily refractory to bortezomib were excluded. Patients were randomized 1:1:1 to Pano 20 mg three times weekly (TIW; the currently approved dosing regimen); Pano 20 mg twice weekly (BIW), or Pano 10 mg three times weekly (TIW), all administered in 21-day cycles. Randomization was stratified by number of prior treatment lines (1 vs 2 vs 3 or 4) and by age at screening (≤75 vs >75 years). For Cycles 1–4, all patients ≤75 years old received SC bortezomib 1.3 mg/m² BIW and oral dexamethasone 20 mg on the day of and day after bortezomib injection. Patients aged ≤75 years from Cycle 5 onwards, and patients >75 years for all cycles, received SC bortezomib 1.3 mg/m² once weekly (QW) and oral dexamethasone 20 mg on the day of and day after bortezomib injection.
Patients were treated until progressive disease or death, or until discontinuation due to toxicity or withdrawal of consent. The primary endpoint was overall response rate (ORR; IMWG 2011 criteria) after up to 8 treatment cycles by Independent Review Committee assessment. Secondary endpoints included best response, time to response (TTR), duration of response (DOR), and safety.
Pano 20mg TIW dosing demonstrated efficacy results comparable to and more durable than those seen in PANORAMA-1, with an ORR of 62.2% (N=78), compared to 60.7% (n=387) in PANORAMA 1; and a median duration of response of 22 months, compared to 13.1 months in PANORAMA 1. For the 20mg TIW group, the incidence of diarrhea across all grades was 66.5% (versus 68% in PANORAMA-1), with Grade >3 diarrhea occurring in 11.5% of patients (versus 25% in PANORAMA-1). Further details of the efficacy and safety results can be found HERE for the ASH abstract and HERE for the  Lancet Oncology paper.
The conclusion of the authors was that the 20 mg TIW and 20 mg BIW dosing regimens provided favorable outcomes, with the most durable and deepest responses observed in the 20 mg TIW arm. As noted in part above, rates of several important AEs, including severe diarrhea, with Pano 20 mg TIW were considerably lower in PANORAMA-3 than those observed with the same dosing regimen in PANORAMA- 1, suggesting SC administration of bortezomib meaningfully improves tolerability of the triplet, as compared with IV administration. All three regimens of FVd proved generally manageable. Pano 20 mg TIW yielded the greatest durable efficacy, most notably a median DOR of 22 months.
About Secura Bio, Inc.
Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide commercialization of impactful oncology therapies for physicians and their patients.  For more information on Secura Bio, please visit www.securabio.com
About FARYDAK (panobinostat)
INDICATION
FARYDAK^® (panobinostat) capsules, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
IMPORTANT SAFETY INFORMATION
WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES
Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK.
Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.
Diarrhea
Cardiac Toxicities
Hemorrhage
Myelosuppression
Infections
Hepatotoxicity
Embryo-Fetal Toxicity
DRUG INTERACTIONS
ADVERSE REACTIONS
Please see full Prescribing Information, including Boxed WARNING, for FARYDAK® (panobinostat) capsules.
Velcade^® is a registered trademark of Takada Pharmaceutical Company Ltd.
Related Links
https://www.securabio.com
SOURCE Secura Bio, Inc.
https://www.securabio.com

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