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TESARO, Inc.
, an
oncology-focused biopharmaceutical company, today announced that final results
from a Phase 1 trial of niraparib, an inhibitor of poly ADP-ribose polymerase
(PARP), were presented this morning at the American Society of Clinical
Oncology (ASCO) annual meeting in Chicago.
At a dose of 300 milligrams once daily, which represents the dose and schedule
that will be utilized in the Phase 3 studies, 75% (three of four patients)
with platinum sensitive high grade serous ovarian cancer (HGSOC) achieved a
RECIST response. Across all dose levels (30 milligrams to 400 milligrams
daily), a RECIST response rate of 46% (6/13 patients) was observed in this
population. A RECIST response rate of 50% (5/10 patients) was achieved in
patients with platinum sensitive ovarian cancer and germline BRCA mutations.
The median duration of response was 431 days for platinum sensitive germline
BRCA patients and 444 days for platinum sensitive patients who were not
germline BRCA mutation carriers.
In addition, 50% (two of the four patients) with BRCA-positive breast cancer
achieved a response. Of the 10 patients with prostate cancer who had evaluable
circulating tumor cell count (CTC) levels, seven (70%) had a reduction of >30%
in CTC count.
The ovarian cancer patients enrolled in this study had received a median of
six previous regimens of systemic therapy. The breast cancer patients enrolled
in this study had received a median of five previous regimens of systemic
therapy.
Pharmacokinetic parameters were dose proportional and support once per day
oral dosing of niraparib. Niraparib was generally well tolerated at 300
milligrams daily, with a low rate of grade 3/4 toxicities. Thrombocytopenia
was identified as the dose-limiting toxicity at a daily dose level of 400
milligrams. The most frequently observed adverse events at the 300 milligram
dose included grade 1/2 anemia, fatigue and nausea.
"We are very pleased with the RECIST response rates observed in both ovarian
and breast cancer patients in this trial, particularly at the 300 milligrams
once daily dose that will be evaluated in our Phase 3 program," said Dr. Mary
Lynne Hedley, President of TESARO. "The results of this study provide further
support for the design of our planned Phase 3 trials in ovarian and breast
cancer and, in particular, the potential utility of platinum sensitivity and
BRCA status as predictors of response to niraparib."
Phase 1 Study Design
This Phase 1 study was designed as a two part trial to determine the maximum
tolerated dose and evaluate preliminary antitumor activity,
safety/tolerability, pharmacokinetic and pharmacodynamic properties of
niraparib. Part A enrolled 60 patients who received a single daily dose of 30
to 400 milligrams of niraparib. Following identification of the maximum
tolerated dose, Part B of the study enrolled an additional 40 patients with
platinum resistant high grade serous ovarian cancer or castration-resistant
prostate cancer who received a single daily dose of 300 milligrams of
niraparib. Preliminary results of this study were presented at the ASCO annual
meeting in 2011.
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