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 February 27, 2017
Gilead Sciences reported 144-week data from two phase III studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg) for the treatment of HIV-1 infection in treatment-naïve adults. In the combined analysis, a total of 1,733 treatment-naïve adults with HIV were randomized to receive either Genvoya or Stribild. At week 144, 84.2% (n=729/866) of patients taking Genvoya and 80% (n=694/867; 95% CI: 0.6% to 7.8%, p=0.021) of patients taking Stribild achieved HIV-1 RNA levels less than 50 copies/mL. Additionally, at week 144, 81.1% (n=702/866) of patients taking Genvoya and 75.8% (n=657/867; 95% CI: 1.5 to 9.2%, p=0.006) of patients taking Stribild achieved HIV-1 RNA levels less than 20 copies/mL, a secondary endpoint. At week 144, virologic failure was similar between groups (Genvoya, 4.6%; Stribild, 3.9%); the difference in overall results was driven by fewer discontinuations on Genvoya due to adverse events or other reasons not related to efficacy (Genvoya, 11.2%; Stribild, 16%). There were statistically significant fewer adverse events leading to discontinuation in the Genvoya arm compared to the Stribild arm (Genvoya, 1.3%; Stribild, 3.3%, p=0.01). The most common drug-related adverse events in both groups were nausea, diarrhea and headache.
OncoGenex Pharmaceuticals reported results of apatorsen in two randomized phase II clinical trials for bladder and prostate cancer. The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (overall survival hazard ratio (HR)=0.80; 80% CI: 0.65-0.98; p=0.078). Partial or complete responses occurred in 16.2% patients receiving apatorsen plus docetaxel compared to 10.9% patients receiving docetaxel alone with median response durations of 6.2 months versus 4.4 months, respectively. Higher baseline serum heat shock protein 27 (Hsp27) levels were significantly prognostic for indicating an almost two-fold higher risk of death (HR=1.96; p=0.0001). In an exploratory analysis on a subset of patients (20% of total) who completed at least two treatment cycles and had either a decrease in serum Hsp27 levels from baseline or had only a 20.5% increase in serum Hsp27 levels from baseline, the reduction in risk of death with apatorsen treatment was 71% (HR=0.29: 80% CI: 0.18-0.48; interaction p=0.0727). The Pacific trial evaluated the ability of apatorsen, when added to Zytiga (abiraterone acetate), to reverse or delay treatment resistance in 72 men who were experiencing a rising PSA on Zytiga alone. The primary endpoint evaluated the proportion of patients who were progression free (clinical and radiologic) at study day 60 with apatorsen added to Zytiga, compared to continuing Zytiga alone. In men receiving apatorsen, 33% were progression free at study day 60 compared to 17% for those men receiving Zytiga alone. For patients with five circulating tumor cells (CTCs) at baseline, 22% vs 11% of patients had a CTC reduction to less than five CTCs when apatorsen was added to Zytiga vs Zytiga alone, respectively. Clinical data from trials in bladder and prostate cancers demonstrated apatorsen was well-tolerated and improved patient outcomes when administered in combination with standard-of-care treatments.
Pfizer and Celltrion Healthcare released results of Inflectra (infliximab CT-P13) for moderate to severe Crohn’s disease (CD). The randomized, double-blind, parallel-group, phase III study compared overall safety and efficacy between Inflectra and Remicade in terms of Crohn’s Disease Activity Index (CDAI)-70 response rates. The primary endpoint of the 54-week study was collected at week six to demonstrate that Inflectra is similar to Remicade in the treatment of CD. The clinical trial enrolled 214 patients and met its primary endpoint demonstrating that, at six weeks, Inflectra was similar to Remicade in the treatment of CD, thereby meeting the criterion for non-inferiority. Crohn’s Disease Activity Index (CDAI-70), a well-established assessment of treatment response in CD. The response rates, 71.4% for Inflectra and 75.2% for Remicade, were not statistically significantly different. Inflectra is marketed as Inflectra (infliximab-dyyb) in the U.S. and under other brand names in some countries.