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 July 17, 2017

Allergan reported results of two phase III studies (IBS-3001 and IBS-3002), which evaluated the efficacy and safety of Viberzi (eluxadoline) in nearly 2,500 irritable bowel syndrome with diarrhea (IBS-D) patients, of whom 36% reported use of loperamide in the 12 months prior to study randomization. Data demonstrate Viberzi safely and effectively treats the IBS-D symptoms of abdominal pain and diarrhea irrespective of prior use of loperamide. These analyses also demonstrated efficacy and safety in patients with loperamide rescue medication use compared to the overall population during the two studies. Among patients who reported prior loperamide use with inadequate symptom control, a significantly greater proportion of patients treated with eluxadoline were composite responders over weeks one to 12 compared with those treated with placebo (eluxadoline 100mg: 27% (P<0.001) and 75mg: 26.3% (p=0.001) versus placebo 12.7%). The most commonly reported adverse events (AEs) are consistent with the known safety profile of eluxadoline, which were nausea, abdominal pain, constipation and headache.

Amgen reported positive results from the final analysis of the phase III ASPIRE trial. The international, randomized ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated KYPROLIS in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed multiple myeloma, following treatment with one to three prior regimens. The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included OS, overall response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety. Patients were randomized to receive KYPROLIS (20mg/m2 on days one and two of cycle one, escalating to 27mg/m2 on days eight, nine, 15 and 16 of cycle one and continuing on days one, two, eight, nine, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25mg per day for 21 days on, seven days off) and low-dose dexamethasone (40mg per week in four-week cycles), versus lenalidomide and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America, Europe and Israel. The study met the key secondary endpoint of overall survival (OS), demonstrating that KYPROLIS (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR=0.79, 95% CI, 0.67 0.95). Per protocol, patients received 18 cycles of KYPROLIS with Rd before continuing treatment with Rd alone to progression. This KRd regimen of twice-weekly KYPROLIS administered at 27mg/m2 is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ASPIRE study.