Clinical Trial Resource Center

Clinical Trial Resource Center

New Medical Therapies™

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 20, 2014

Antisense Therapeutics released results of a phase IIa trial of ATL1102 for relapsing-remitting multiple sclerosis (RRMS). In the randomized, double-blind, placebo-controlled study in 77 patients, ATL1102 met its primary end point after only two months of dosing, showing a significant reduction, by 54.4% (p=0.01), in the cumulative number of new active brain lesions in patients taking ATL1102 compared to placebo. The efficacy outcomes from this study were viewed to be as good as, or superior to, those achieved with MS drug Tysabri at a similar stage in its clinical development. Antisense now is seeking FDA guidance and agreement on the intended content of the planned IND Submission. The FDA has confirmed that its goal date for responding is Oct. 17.

Boehringer Ingelheim issued results of a phase III trial of afatinib v. erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung. In the randomized, open-label trial, 795 patients with stage IIIB/IV SCC of the lung were randomized 1:1 to receive afatinib or erlotinib until disease progression. The planned primary analysis was based on 414 progression-free survival (PFS) events by independent review in the first 669 patients randomized (afatinib: 335, erlotinib: 334) while recruitment was ongoing. Afatinib significantly reduced the risk of disease progression by 18% when compared to erlotinib and delayed tumor growth (PFS by independent review: 2.4 v. 1.9 months; HR=0.82; p=0.043). Treatment with afatinib showed improvement in the secondary endpoint of disease control rate (DCR) compared to erlotinib (DCR: 45.7% v. 36.8%; p=0.020). Objective response rate was 4.8% in the afatinib arm v. 3% in the erlotinib arm (p=0.233). More patients reported an improvement in their global health status/quality of life (p=0.026) and cough (p=0.01) with afatinib v. erlotinib; no difference was observed with pain (p=1.0) and dyspnea (p=0.298) between groups. There was no significant difference in the time to deterioration across these four measures. The overall rate of severe (>/= grade 3) adverse events was comparable between both therapies. Incidence of severe adverse events was 50.2% in patients treated with afatinib compared to 49.1% with erlotinib. A higher incidence of severe diarrhea and stomatitis was observed in patients treated with afatinib compared to erlotinib (severe diarrhea: 9% v. 2%; stomatitis: 3% v. 0%), while there was a higher incidence of severe rash/acne observed with erlotinib compared to afatinib (9% v. 6%).

Puma Biotechnology issued results of a phase II trial of PB272 (neratinib) for the treatment of non-small cell lung cancer (NSCLC) with HER2 mutations. In the trial, patients with confirmed stage IIIB or stage IV NSCLC with documented somatic HER2 mutations were randomized to receive either oral neratinib monotherapy, 240mg per day, or the combination of oral neratinib, 240mg daily, with intravenous temsirolimus administered at a dose of 8mg per week. A total of 27 patients completed the first stage of the trial; 13 of these patients received neratinib monotherapy and 14 of these patients received the combination of neratinib plus temsirolimus. Results showed that of the 13 patients who received neratinib monotherapy, no patient experienced a partial response, seven (54%) patients achieved stable disease and four (31%) patients achieved clinical benefit (defined as a partial response or stable disease for 12 or more weeks). For the 14 patients who received the combination of neratinib plus temsirolimus, three (21%) patients experienced a partial response, 11 (79%) patients experienced stable disease and nine (64%) patients achieved clinical benefit. The median progression free survival of the neratinib monotherapy arm was 2.9 months and the median progression free survival of the arm that received neratinib plus temsirolimus was four months. Patients continue to be enrolled in the arm of the trial that is receiving the combination of neratinib plus temsirolimus.