Breast Pain

November 2, 2015

Immunomedics has reported results of a phase III trial of sacituzumab govitecan for metastatic triple-negative breast (TNBC), small-cell (SCLC) and non-small-cell lung (NSCLC) cancers. At the time of analysis, 56 enrolled patients had received sacituzumab govitecan at the optimal dose of 10mg/kg given on days one and eight of a three-week cycle. Treatment response was available for 52 patients. The objective response rate was 29% (15/52), with two confirmed complete responses. The interim median progression-free survival (PFS), a measure of time patients are living without their cancer progressing, was seven months. Forty-six percent of these TNBC patients had experienced a PFS event. Overall survival (OS) data were too early to report because 86% of patients are still alive. For metastatic lung cancers, 33 patients with NSCLC were enrolled to receive sacituzumab govitecan at the or 10mg/kg dose level. Among 29 patients assessable, an objective response rate of 28% (8/29) was observed, including patients with both squamous cell and adenocarcinoma NSCLC types. For the 25 patients at the 10mg/kg dose, the interim median PFS was 3.8 months, with 48% of patients in this dose group having experienced a PFS event. In SCLC, of the 27 patients enrolled at doses of 8mg/kg and 10mg/kg, 25 were assessable for response. Six patients achieved a partial response (objective response rate=24%). Interim median PFS for the 12 patients at the 10mg/kg dose level was 3.6 months and 83% of patients had experienced a PFS event. Since 96% of NSCLC patients and 100% of SCLC patients were still alive at the time of analysis, OS data at the optimal dose of 10mg/kg are too early to report. Sacituzumab govitecan has received Fast Track designation from the FDA for the treatment of patients with TNBC, SCLC and NSCLC, and also has been designated an orphan drug for SCLC or pancreatic cancer in the U.S., and for the treatment of patients with pancreatic cancer in the E.U.

May 16, 2005

Ascend Therapeutics presented positive results of a phase II trial of a topical gel formulation of 4- hydroxytamoxifen (4-OHT), for the treatment of menstrual-cycle related mastalgia, at the 53rd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. Data from the study indicated that the highest dose of the drug significantly reduced symptoms severity vs. placebo, as measured by primary Visual Analogue Scale score (-32.1 mm vs. -19.3 mm, respectively; p=0.034), and secondary physician global assessments of pain (OR, 0.32; p=0.01), tenderness (OR, 0.33; p=0.012), and nodularity (OR, 0.30; p=0.017), and patient assessment of pain (OR, 0.36; p=0.022). No disruptions of menstrual cycles or menses were noted over the course of treatment, and plasma hormone levels were unaffected. This randomized, double- blind, placebo-controlled, dose-ranging study enrolled 130 adult premenopausal women with a history of cyclic mastalgia, who received one of two doses of 4-OHT (2 mg once or twice daily) for 4 menstrual cycles.