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Research

New Medical Therapies™

Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of December 15, 2014

Celgene released results of a phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma. The single-arm study enrolled 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response (VGPR). In patients refractory to prior lenalidomide (n=572) or lenalidomide and bortezomib (n=473), similar PFS (4.2 months and 4.1 months), OS (12 months for each) and ORR (34% and 35%) were achieved. A subgroup analysis was conducted to determine the impact of the therapy on patients with moderate renal impairment (RI). Of those enrolled, 215 had moderate RI (Creatinine clearance greater than 45 mL/min but less than 60 mL/min). ORR was generally similar between patient groups receiving pomalidomide plus low-dose dexamethasone (37% with moderate renal impairment v. 33% without moderate renal impairment) despite differences in renal function. Pomalidomide dosing was 4mg daily for days one to 21 of a 28-day cycle. Dexamethasone was given at 40mg/day (20mg for > 75 years) on days 1, 8, 15 and 22. Dose intensity was comparable in both groups (94% and 93%). No dose adjustment was required for renal impairment. Pomalidomide is marketed as Pomalyst in the U.S. and Imnovid in the E.U.

Orexo released results of a phase III trial of Zubsolv compared with Suboxone film during stabilization of patients with opioid dependence. The randomized, multicenter, non-inferiority clinical trial enrolled 758 patients in the maintenance phase of the study with either Zubsolv or Suboxone film. At day 15, Zubsolv patients switched to Suboxone film and those taking Suboxone film switched to Zubsolv. The co-primary endpoint was retention in treatment at day 15. On day 15, the number of patients who were retained in treatment were similar across the Zubsolv and Suboxone film arms (74.9% v. 74.4%, respectively, P=0.866). Despite an average 26% to 32% percent lower dose of buprenorphine in Zubsolv compared to that in Suboxone film used, Zubsolv showed comparable efficacy to Suboxone film, which may help reduce the potential for misuse. Zubsolv also demonstrated no increased rate of withdrawal symptoms or opioid cravings versus Suboxone film at day 15 and day 22. The safety profile of Zubsolv was similar to that of Suboxone film.

Otsuka Pharmaceutical and H. Lundbeck issued results of a phase III study of brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD). Patients with MDD who failed to reach adequate response during one to three treatment attempts with ADT were enrolled and received an additional trial with a (single-blind) ADT for eight weeks. Those patients who still failed to reach an adequate response throughout this phase were then randomized (double-blind) to ADT and brexpiprazole or ADT and placebo for six weeks. Adjunctive brexpiprazole showed greater improvement than adjunctive placebo in MADRS (Montgomery–Åsberg Depression Rating Scale) total score at week six in the efficacy population per final protocol in study 1 (2mg+ADT [N=175]: -3.21, p=0.0002), and in study 2 (1mg+ADT [N=211]: -1.30, p=0.0737; 3mg+ADT [N=213]: -1.95, p=0.0079). Similar results were observed for the efficacy population in both studies. Discontinuations due to adverse events were low across all groups (1mg = 1.3%, 2mg = 3.2%, 3mg = 3.5%, placebo = 0.7%) and only one patient discontinued due to lack of efficacy (in the brexpiprazole 1mg group). A NDA for brexpiprazole has been filed with the FDA and the PDUFA date is in July 2015.

Seattle Genetics and Takeda Pharmaceutical reported results of a phase III study of Adcetris (brentuximab vedotin) in Hodgkin lymphoma (HL) patients at risk of relapse following an autologous stem cell transplant (ASCT). The randomized, doubleblind, placebo-controlled study enrolled 329 HL patients, including 165 on the Adcetris arm and 164 on the placebo arm. Patients received a median of 15 cycles of treatment on both arms, with an average of 12 cycles on the Adcetris arm and 11 cycles on the placebo arm. The trial demonstrated a significant increase in PFS per independent review facility (IRF), with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS per IRF was 43 months for patients who received Adcetris v. 24 months for patients who received placebo. The two-year PFS rate per IRF was 63% in the Adcetris arm compared to 51% in the placebo arm. The hazard ratio was 0.50. The two-year PFS rate per investigator was 65% in the Adcetris arm compared to 45% in the placebo arm. In the Adcetris arm, only eight of 51 patients (16%) receiving subsequent therapy were treated with Adcetris following relapse. In the placebo arm, 72 of 85 patients (85%) receiving subsequent therapy were treated with single agent Adcetris. Twenty-four patients in the placebo arm and 13 patients in the Adcetris arm received stem cell transplant as subsequent therapy, the majority of which were allogeneic transplants. Takeda plans to submit data from the Aethera trial to regulatory agencies in its territories.

 
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