trending Market Intelligence /marketintelligence/en/news-insights/trending/tjv_arkuudhkyur6rhdmxg2 content esgSubNav
In This List

ASCO conference: Puma Biotechnology drug combo shrinks breast tumors in trial

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


ASCO conference: Puma Biotechnology drug combo shrinks breast tumors in trial

Puma Biotechnology Inc. said Nerlynx, combined with Roche Holding AG's Kadcyla, shrunk breast cancer patients' tumors in a phase 1b/2 trial.

Nerlynx, also known as PB272 or neratinib, is approved in the U.S. to treat certain patients with breast cancer. Kadclyla is an antibody drug conjugate also known as T-DM1 that is also approved to treat breast cancer.

Puma Biotechnology reported interim data from the study, called FB-10, which enrolled 27 patients with HER2-positive breast cancer that spread to other parts of the body. The patients had been previously treated with chemotherapy as well as a combination of Roche's blockbuster cancer therapies Herceptin and Perjeta.

Of the 20 patients evaluated for efficacy, 60% responded to treatment. Three patients had no detectable cancer after Nerlynx treatment, while nine had a reduction in tumor size. Two patients had no change in tumor size, while six had their cancer progress despite treatment.

The most common grade 3, or severe, adverse events observed in the study were diarrhea, nausea, thrombocytopenia and hypertension.

Puma Biotechnology said patients were treated in escalating doses of 120, 160, 200 and 240 milligrams per day. The trial's phase 2 portion is being conducted at the recommended daily dosage of 160 mg.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on site and an additional 3,350 abstracts to be published online.