Puma Biotechnology, Inc. (PBYI) 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 mutation.
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 cancer).
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 Pfizer, Inc. (PFE).
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 breast cancer.