$PBYI Expands Study Cohort for Cancer Drug – Analyst Blog

Puma Biotechnology, Inc. PBYI announced that it has expanded the second cohort in an open-label, multi-center phase II study (basket trial) on its lead candidate neratinib. The basket trial is evaluating the safety and efficacy of PB272 when administered daily to patients suffering from solid tumors with activating ERBB mutations including epidermal growth factor receptor, HER2 and HER3.

There are nine cohorts in this study, which include patients suffering from bladder/urinary tract, breast, colorectal, endometrial, gastric/esophageal and ovarian cancers, solid tumors with a HER2 mutation, EGFR-mutated and/or amplified primary brain cancer, and solid tumors with a HER3 mutation. In the second cohort, the company is evaluating neratinib as a single agent in patients suffering from metastatic non-small cell lung cancer (NSCLC), whose tumors have a HER2 mutation. Upon expansion of the HER2-mutant NSCLC basket, the company will enroll a total of 18 patients in the cohort.

Puma Biotechnology said that neratinib has the potential to be selectively active in some HER2-mutated NSCLC tumors. Hence, a difference may be seen in neratinib’s activity in the basket trial compared to a previous phase II study on neratinib for NSCLC patients with somatic HER2 mutations, in which there was lesser representation from other HER2 mutations.

Additionally, Puma Biotechnology intends to expand the other cohorts from the basket trial later in 2015.

Meanwhile, the company is developing an intravenous version of neratinib for the treatment of patients suffering from advanced cancer.