Puma Biotechnology, Inc.
) commenced a phase II study (basket) on its oncology candidate
PB272. The open-label, multicenter, multinational study intends
to assess the safety and efficacy of the candidate as a single
agent in patients with solid tumors who have an activating HER2
This study contains six arms with seven patients each
suffering from different cancer forms (1) bladder/urinary tract
cancer, (2) colorectal cancer, (3) endometrial cancer, (4)
gastric/esophageal cancer, (5) ovarian cancer and (6) all other
solid tumors (including prostate, melanoma and pancreatic
If objective response rate is found in the initial 7 patients,
the basket will be expanded to include more patients.
PB272 is being studied for the treatment of patients with
HER2-positive metastatic breast cancer and patients with
non-small cell lung cancer, breast cancer and other solid tumors
that have a HER2 mutation. Puma Biotech has in-licensed exclusive
global rights to PB272 from
In the last quarter, PB272 commenced a phase III study in
patients with HER2-positive metastatic breast cancer who have
failed two or more prior therapies. Patients will be recruited
for this study till the first half of 2014. Puma Biotech also has
plans to start a phase III study of the combination of PB272 plus
Torisel later in 2013.
Puma Biotech expects to complete multiple phase II studies on
PB272 shortly and data is expected by year end - (1) in
combination with temsirolimus in fourth line HER2-positive
metastatic breast cancer, (2) in patients with HER2-positive
metastatic breast cancer that has metastasized to the brain and
(3) as a neoadjuvant treatment for patients with HER2-positive
Puma Biotech carries a Zacks Rank #3 (Hold). Currently,
) look more attractive with a Zacks Rank #1 (Strong Buy).
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