Celgene Corp. (Summit, N.J.)
High-risk early breast cancer patients
Phase III Geparsepto data found a significantly higher DFS rate in patients receiving it compared to those receiving paclitaxel as part of a neoadjuvant treatment regimen (p=0.0044); rates of DFS were 87.1% vs. 80.7% at three years and 83.5% vs. 76.2% at four years, respectively
Daiichi Sankyo Co. Ltd. (Tokyo)
HER2-targeting antibody-drug conjugate
Phase I data of 57 efficacy evaluable patients with HER2-positive metastatic breast cancer pre-treated with Kadcyla showed it produced an overall response rate (ORR) of 61.4% and a disease control rate (DCR) of 94.7%; in the 50 patients who were also pre-treated with Perjeta it produced an ORR of 62% and a DCR of 94%; of the 39 efficacy evaluable patients with hormone-receptor positive disease, it produced an ORR of 56.4% and a DCR of 92.3%; in 19 efficacy evaluable patients with heavily pretreated HER2 low-expressing breast cancer, the ORR was 31.6% and the DCR was 84.2%; in the subgroup of those HER2 low-expressing patients who also had hormone-receptor positive disease, the ORR was 31.3% with a DCR of 87.5%
Puma Biotechnology Inc. (Los Angeles)
Diarrhea caused by Nerlynx associated with trastuzumab-based adjuvant therapy
Interim results from the phase II CONTROL trial showed of the 137 patients who received the loperamide prophylaxis, 30.7% had grade 3 diarrhea; for the 64 patients taking loperamide plus budesonide, the incidence of grade 3 diarrhea was 26.6%; of the 120 patients who received loperamide plus colestipol, 10.8% had grade 3 diarrhea
Seattle Genetics Inc. (Bothell, Wash.)
Antibody-drug conjugate targeting LIV-1
Metastatic triple-negative breast cancer
Phase I showed an objective response rate of 25%; the clinical benefit rate, which also included patients with stable disease lasting at least 24 weeks, was 28%: the median progression-free survival and median duration of response for 19 patients treated at the recommended dose of 2.5 mg/kg, with a maximum dose of 200 mg per cycle, was 12.1 weeks and 17.4 weeks, respectively
The date indicated refers to the BioWorld issue in which the news item can be found.
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