Kyprolis Helped Patients Live 8.7 Months Longer Without Their Disease Worsening
Results to Form Basis of Regulatory Filings Beginning in 1H 2015

Thousand Oaks, California and South San Francisco, California (Press Release) Amgen (NASDAQ:AMGN) and its sub­sid­i­ary, Onyx Pharma­ceu­ticals, Inc., today announced that a planned interim analysis demon­strated that the Phase 3 clin­i­cal trial ASPIRE (CArfilzomib, Lena­lido­mide, and DexamethaSone versus Lena­lido­mide and Dexamethasone for the treat­ment of PatIents with Relapsed Multiple MyEloma) met its pri­mary end­point of pro­gres­sion-free survival (PFS). Patients treated with Kyprolis® (car­filz­o­mib) for Injection in com­bi­na­tion with Revlimid® (lena­lido­mide) and low-dose dexa­meth­a­sone (KRd) lived sig­nif­i­cantly longer without their disease worsening (median 26.3 months) compared …

Six Data Presentations at the European Hematology Association's 19th Congress

Natick, Massachusetts (Press Release) - Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced initial Phase 1 data from patients with multiple myeloma treated with Karyopharm's lead selective inhibitor of nuclear export (SINE), Selinexor (KPT-330), in com­bi­na­tion with "low-dose" (20 mg twice weekly) dexa­meth­a­sone. Among eight patients, the best responses were one stringent com­plete response (sCR), three partial responses (PRs), two minor responses (MRs), one pro­gressive disease and one non-evaluable. Accordingly, the clin­i­cal benefit response rate (sCR+PR+MR) is 75% and the over­all response rate (sCR+PR) is 50%. These new results will be …

• Results show adding LBH589 to bortezomib and dexamethasone significantly improved PFS by 37%, meeting Phase III study primary endpoint[1]
• Median PFS increased by 4 months (12 months in LBH589 arm versus 8 months in placebo arm); effect of LBH589 observed across all patient subgroups[1]
• Most people with multiple myeloma will relapse or become refractory; if approved, LBH589 will be first in its class of anticancer agents available to this population[1]
• Based on these data, US

 …

Findings from a prospective Phase 2 clinical trial indicate that the com­bi­na­tion of Revlimid, Velcade, and dexamethasone is effective in relapsed and refractory multiple myeloma patients.

The trial enrolled 64 patients, who had been treated with a median of two prior therapies, at six different U.S. cancer centers from 2006 to 2008.

Nearly two-thirds of the patients in the trial achieved at least a partial re­sponse, despite the fact that more than half of the patients had previous­ly been treated with Velcade (bortezomib), and nearly three quarters had previously been …

POMALYST Is A New Option For Patients Whose Disease Has Progressed Despite Treatment With Available Therapies

Mississauga, Ontario (Press Release) - Health Canada has approved POMALYST™ oral ther­apy (poma­lido­mide capsules) in com­bi­na­tion with dexa­meth­a­sone, for patients with multiple myeloma for whom both lena­lido­mide and bor­tez­o­mib have failed, who have received at least two prior treat­ment regi­mens and have dem­onstrated dis­ease pro­gres­sion on their last regi­men. Until POMALYST, there have been few options for patients whose dis­ease has progressed despite being treated with traditional ther­a­pies. Treatment with POMALYST has been shown to im­prove rates of over­all survival and extend pro­gres­sion-free survival in patients who no longer respond to lena­lido­mide …

Monday was the third day of this year’s meeting of the American Society of Hematology (ASH).  The day was filled with oral presentation sessions from early in the morning until into the evening.

In the afternoon and early evening, there were six oral presentation sessions devoted solely to multiple myeloma and a number of other myeloma-related presentations scattered about the afternoon.  The topics of these presentations ranged from the biology of myeloma to treat­ment options for newly diag­nosed, re­lapsed and refractory, and older patients.

This ASH update highlights most of the oral …

- Study of LBH589 plus bor­tez­o­mib and dexa­meth­a­sone met pri­mary end­point of extending PFS compared to bor­tez­o­mib plus dexa­meth­a­sone and placebo
- LBH589 has poten­tial to be the first in its class of anticancer agents avail­able to patients with multiple myeloma
- Data will be presented at an upcoming medical congress and discussed with regu­la­tory author­i­ties world­wide

Basel, Switzerland (Press Release) - Novartis today announced that results of a Phase III trial of the in­ves­ti­ga­tional com­­pound LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, met the pri­mary end­point of sig­nif­i­cantly extending pro­gres­sion-free …