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 March 27, 2017
Eli Lilly issued results of a phase III trial of abemaciclib in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy. The global, double-blind study had an intent-to-treat population of 669 patients randomized to receive abemaciclib or placebo orally twice a day on a continuous dosing schedule, given in combination with fulvestrant at its approved dose and schedule, until disease progression. Patients enrolled in the study had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease. Patients who had received chemotherapy in the metastatic setting were not eligible for the study. The most common adverse events observed were diarrhea, neutropenia, nausea and fatigue, and were consistent with the previous studies of abemaciclib. Lilly intends to submit a new drug application (NDA) for single-agent abemaciclib in the second quarter of 2017.
Jazz Pharmaceuticals released results of two global multicenter phase III studies of JZP-110 for excessive sleepiness associated with obstructive sleep apnea (OSA). TONES 3 was a 12-week, five-arm, parallel-group, double-blind, placebo-controlled, randomized study evaluating JZP-110 at 300mg, 150mg, 75mg and 37.5mg compared to placebo. TONES 4 was a six-week study comprising a two-week flexible-dose titration phase followed by two weeks at stable dose, and then a two-week, placebo-controlled, double-blind randomized withdrawal phase. TONES 3 demonstrated highly statistically significant improvement in the co-primary endpoints of Maintenance of Wakefulness test (MWT) and Epworth Sleepiness scale (ESS) at all doses. In addition, the key secondary endpoint of Patient Global Impression of Change (PGIc) scale demonstrated a highly statistically significant improvement. On the co-primary endpoints of MWT and ESS, the study demonstrated that treatment with JZP-110 significantly increased the patients’ ability to stay awake and significantly decreased patients’ subjective levels of sleepiness, respectively, compared to placebo. These effects were maintained throughout the course of the study. In the TONES 4 study, at the end of week four, 126 patients who reported “much” or “very much” improvement on the PGIc scale and who had numerical improvements on the MWT and ESS at week four were then randomized 1:1 to receive either the same dose of JZP-110 received in the stable dose phase, or placebo, for two weeks in the randomized withdrawal phase. In TONES 4, patients randomized to continue on JZP-110 maintained efficacy, while those randomized to placebo experienced a loss of efficacy, as measured by the co-primary and key secondary endpoints.
Neurocrine Biosciences reported results of a phase III trial of Ingrezza (valbenazine) for the treatment of tardive dyskinesia (TD). The Kinect 3 study was a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in which 234 subjects with TD and underlying schizophrenia, schizoaffective disorder or mood disorder received six weeks of once-daily Ingrezza (40mg or 80mg capsules) or placebo. The study met its primary endpoint of change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at week six in the 80mg once-daily dosing group compared to placebo. The mean change from baseline to week six in the AIMS rating was -3.2 for the 80mg once-daily group as compared to -0.1 in the placebo group (p>0.0001). In addition, the percentage of participants who achieved an AIMS response was higher in the Ingrezza 80mg/day group compared to placebo at all study visits. At week six, 40% (p<0.001) of participants receiving
80mg/day of Ingrezza had at least a 50% improvement in AIMS dyskinesia score as compared to only 8.7% of those who received placebo. Ingrezza was generally well-tolerated and the most common adverse reactions were somnolence and drooling. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies. There were no drug-drug interactions identified in subjects who were utilizing a wide range of psychotropic and other concomitant medications. Neurocrine has submitted a New Drug Application (NDA) to the FDA for Ingrezza and has been granted Priority Review. Neurocrine received Breakthrough Therapy Designation from the FDA in 2014 for Ingrezza for the treatment of TD.