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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 21, 2017

ASLAN Pharmaceuticals issued results of a phase II study of varlitinib (ASLAN001) in combination with capecitabine as second-line treatment for metastatic HER2-positive breast cancer patients progressing on trastuzumab (Herceptin). The multinational, randomized, open-label study compared the effects of varlitinib combined with capecitabine versus that of lapatinib (Tykerb) combined with capecitabine on tumor shrinkage at week 12. Top-line data showed significantly greater tumor shrinkage at week 12 of the treatment cycle in patients who were on therapy for more than a month, receiving 400mg varlitinib (36.4%) twice daily compared to 1,250mg lapatinib (17.8%) once daily (p=0.075). A total of 50 patients were enrolled in the study. While the study was not powered for objective response rate (ORR), it found that patients dosed with varlitinib showed higher ORR compared to patients on lapatinib (60% versus 46%). There were no differences in progression-free survival (PFS) or overall survival (OS) in the study. Adverse events reported included nausea, vomiting and diarrhoea, and occurred at similar frequency in both arms. The incidence of grade three diarrhea was 12.5% in the varlitinib group and was clinically manageable. There were no instances of grade four diarrhea.

Merck KGaA released results of a phase III study of Cladribine Tablets for brain atrophy related to relapsing remitting multiple sclerosis (RRMS). The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled, international study. It randomized 1,326 patients with relapsing remitting MS according to the revised McDonald criteria. Study participants were randomized to one of three different treatment groups consisting of two different dose regimens of Cladribine Tablets or matching placebo tablets (1:1:1 ratio). The brain atrophy analysis evaluated the effect of Cladribine tablets on brain volume loss (BVL) over two years in RMS and the association of BVL with confirmed disability progression in 1,025 (77.3%) of the patients in CLARITY. The mean percentage brain volume loss per year was significantly reduced in patients treated with Cladribine Tablets 3.5mg/kg (0.56%±0.68, p=0.010, n=336) and 5.25mg/kg (0.57%±0.72, p=0.019, n=351) compared with patients treated with placebo (0.70%±0.79, n=338). The risk of disability progression was also significantly lower in patients treated with Cladribine Tablets 3.5mg/kg (HR 0.63, 95% CI 0.438, 0.894; p=0.010) and 5.25mg/kg (HR 0.58, 95% CI 0.406, 0.833; p=0.003) than in those treated with placebo. After adjusting for treatment group, percentage brain volume loss per year showed a significant correlation with the cumulative probability of disability progression in the overall study population (HR 0.67, 95% CI 0.571, 0.787; p<0.0001). Lymphopenia was the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99% rated mild-to-moderate by investigators.

Theratechnologies released results of a phase III trial of ibalizumab for treatment-experienced patients infected with multidrug resistant HIV-1. TMB-301 was a single arm, 24-week study of ibalizumab plus optimized background regimen (OBR). Patients receiving their current failing antiretroviral therapy (ART), or no therapy, were monitored during a seven-day control period. Thereafter, a single loading dose of 2,000mg of intravenous (IV) ibalizumab was the only ART added to their regimen. The primary efficacy endpoint was the proportion of patients achieving a 0.5 log10 decrease in HIV-1 RNA seven days after initiating ibalizumab therapy, day 14 of the study. Ibalizumab was continued at doses of 800mg IV every two weeks through 24 weeks on study treatment. A total of 40 patients have been enrolled in the study. The new data showed that patients with multidrug resistant (MDR) HIV-1 infection experienced a mean increase in CD4+ T cell of 48 cells/μL after 24 weeks of treatment with ibalizumab plus an optimized background regimen (OBR). These data supplement previously reported findings, where 83% of patients achieved a 0.5 log10 decrease in viral load from baseline seven days after the single loading dose of 2000 mg of ibalizumab (primary endpoint) and a mean reduction in viral load of 1.6 log10 over the 24 week treatment period with more than 48% of patients experiencing a viral load reduction of more than 2.0 log10. A BLA to the FDA has been submitted.

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