Amgen has given a first glimpse of key results from its FOCUS Phase 3 clinical trial testing Kyprolis in re­lapsed and refractory multiple myeloma patients.

The com­pany reported this past Wednesday that Kyprolis did not provide an over­all survival advantage in the trial, which is being con­ducted out­side the United States.

In addi­tion, the com­pany noted that patients treated with Kyprolis during the trial experienced more kidney-related side effects than patients who were not treated with the drug.

Up until recently, the primary significance of the FOCUS trial would have been its …

Thousand Oaks, California and South San Francisco, California (Press Release) - Amgen (NASDAQ: AMGN) and its sub­sid­i­ary, Onyx Pharma­ceu­ticals, Inc., today announced that the Phase 3 clin­i­cal trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) did not meet its pri­mary end­point of im­prov­ing over­all survival (OS) (HR=0.975, 95 per­cent CI, 0.760, 1.249). The 315-patient, open-label study eval­u­ated single-agent Kyprolis® (car­filz­o­mib) for Injection compared to an active control regi­men of low-dose dexa­meth­a­sone, or equivalent corticosteroids, plus optional cyclo­phos­pha­mide in patients with re­lapsed and ad­vanced refractory multiple myeloma. Nearly all patients in …

Cambridge, MA (Press Release) – Millennium: The Takeda Oncology Company with its parent com­pany, Takeda Pharma­ceu­tical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved VELCADE® (bor­tez­o­mib) for the retreatment of adult patients with multiple myeloma (MM) who had pre­vi­ously responded to VELCADE ther­apy and re­lapsed at least six months fol­low­ing completion of prior VELCADE treat­ment. The labeling update in­cludes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in com­bi­na­tion with dexa­meth­a­sone in patients …

Amgen this morning announced initial results of its Phase 3 “ASPIRE” trial com­par­ing Kyprolis-Revlimid-dex­a­meth­a­sone to Revlimid-dex­a­meth­a­sone in pa­tients with re­lapsed multiple myeloma.

Patients in the trial who received the Kyprolis-Revlimid-dex­a­meth­a­sone com­bi­na­tion (KRd) had significantly longer pro­gres­sion-free survival (26.3 months) than patients who received only Revlimid and dex­a­meth­a­sone (Rd) (17.6 months).

There was also a trend in the results toward improved over­all survival among the patients who received KRd versus those who did not. How­ever, the difference is not yet statistically significant.

The results of the trial are important for two reasons.

First, …

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 …

This year’s American Society of Clinical Oncology (ASCO) annual meeting in Chicago ended last Tuesday.

The day before the meeting ended was the busiest day at the meeting with re­gard to myeloma research.  It featured a session of oral pre­sen­ta­tions in the morn­ing and a poster session in the afternoon. In addi­tion, an education ses­sion was held in the afternoon that included one myeloma-related talk, given by Dr. Leif Bergsagel of the Mayo Clinic, about progress in the treat­ment of mul­ti­ple myeloma (article in the ASCO 2014 Edu­ca­tional Book).

This update …

This year’s American Society of Clinical Oncology (ASCO) annual meeting began yester­day morning in Chicago and will run through Tuesday.

Myeloma-related pre­sen­ta­tions were made during two sessions yes­ter­day.

One session was designed to better educate physicians about per­son­al­ized ther­apy for elderly patients with lymphoid malig­nan­cies. During that session, Dr. Tanya Marya Wildes from the Washington University School of Medicine in St. Louis talked about how to navigate treat­ment options for older multiple myeloma patients.

The key myeloma-related re­search pre­sented yesterday was made public during a poster session in the afternoon about studies …