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 8.mg/kg 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.