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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 October 5, 2015

Boehringer Ingelheim has released results of a phase III trial of fatinib compared to erlotinib for the treatment of patients with previously treated advanced squamous cell carcinomas (SCC) of the lung. More patients had improved overall health-related quality-of-life (36% v. 28%, p=0·041), cough (43% v. 35%, p=0·029) and dyspnoea (51% v. 44%, p=0·061) with afatinib than with erlotinib. The rate of severe adverse events in the LUX-Lung 8 trial was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhoea: 10% v. 2%; grade 3 stomatitis: 4% v. 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% v. 6%). Diarrhoea occurring in patients treated with afatinib was manageable. Afatinib is under review by both the FDA and EMA for the treatment of SCC of the lung. Afatinib also has been granted Orphan Drug designation by the FDA. Afatinib currently is approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

Exelixis has issued results of a phase III trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. The median PFS was 7.4 months for the cabozantinib arm v. 3.8 months for the everolimus arm, corresponding to a 42% reduction in the rate of disease progression or death for cabozantinib as compared to the everolimus arm (hazard ratio [HR]=0.58, 95% confidence interval [CI] 0.45-0.75, p<0.001). The company is on track to complete an NDA filing with the FDA by the end of 2015. Cabozantinib has received Breakthrough Therapy designation in the U.S. and Exelixis expects a European filing to follow in early 2016.

Gilead Sciences has issued results of phase III studies (ASTRAL-1, ASTRAL-2, ASTRAL- 3 and ASTRAL-4) of sofosbuvir (SOF) with velpatasvir (VEL) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection. In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1-6 HCV infection received 12 weeks of SOF/VEL. Among those patients, 21% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was SVR12. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98%) achieved the primary efficacy endpoint of SVR12. Of the 20 patients who did not achieve SVR12, 13 patients (1.3%) experienced virologic failure and seven did not complete an SVR12 visit (e.g., lost to follow-up). Twelve of the 13 virologic failure patients relapsed (two genotype 1 HCV-infected patients and 10 genotype 3 HCV-infected patients). There was one patient with documented re-infection. No patients with genotype 2, 4, 5 or 6 HCV infection had virologic failure. In ASTRAL-4, patients with Child-Pugh class B cirrhosis receiving SOF/VEL+RBV achieved higher SVR12 rates than patients receiving SOF/VEL for 12 or 24 weeks. Among genotype 1 and 3 patients treated with SOF/VEL+RBV for 12 weeks, the SVR12 rates were 96% and 85%, respectively. The FDA has assigned the SOF/ VEL fixed-dose combination a Breakthrough Therapy designation.

Merck has reported results of two pivotal phase III clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence. MODIFY I and MODIFY II were double-blind, placebo-controlled trials that enrolled 1,452 and 1,203 patients, respectively. The studies were conducted in both hospital and outpatient settings, and the primary endpoint for each study was evaluated through 12 weeks following study drug administration. In the MODIFY I study, patients receiving standard-of-care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10mg/kg) (n=403), actoxumab (10mg/kg) (n=242), the combination of bezlotoxumab and actoxumab (10mg/kg each) (n=403) or placebo (n=404). The actoxumab arm was stopped for efficacy and safety reasons after an interim analysis. In the MODIFY II study, patients receiving standard-of-care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10mg/kg) (n=407), bezlotoxumab and actoxumab (10mg/kg each) (n=397) or placebo (n=399). In both trials, the rate of C. difficile infection recurrence through week 12, the primary efficacy endpoint, was significantly lower in the bezlotoxumab arms (17.4%, p=0.0003) and (15.7%; p=0.0003), and the combination bezlotoxumab and actoxumab arms (15.9%, p<0.0001) and (14.9%, p<0.0001), compared to the placebo arms (27.6%) and (25.7%), respectively. Based on those results, the company plans to submit New Drug Applications seeking regulatory approval of bezlotoxumab in the U.S., E.U. and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

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