March 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – There may be a brighter future for breast cancer patients as there are now more than 1,000 drugs in active development in pharmaceutical company pipelines, according to a new analysis by GBI Research.
According to data released by the New York-based research organization, there are 1,050 drugs in active development across multiple trial stages, with 347 programs being “first in class.” With this number of breast cancer treatments in development, GBI said the “clinical and commercial landscape of the disease market” will be significantly impacted over the next ten years. What’s driving the huge number of drugs in development is a “growing patient pool, a well-established market with multiple unmet needs, and a robust understanding of the disease pathophysiology, facilitating the development of novel compounds that may fill such needs,” GBI said.
Dominic Trewartha, managing analyst for GBI Research, said the current breast cancer pipeline has the potential to yield therapies that “outperform existing products and mechanisms of action.”
“Breast cancer has the largest product pipeline in the pharmaceutical industry, and its significant patient population and successful commercialization of drugs such as Herceptin have attracted a great deal of R&D investment,” Trewartha said in a statement.
Genentech ’s Herceptin, which was approved in 2002, has been hailed for its efficacy in treating HER-2-positive breast cancer, which is caused by the over production of the HER-2 gene in tumor cells. Last year, Genentech reported Herceptin, mixed with a complimentary drug pertuzumab and marketed under the brand name Perjeta, and docetaxel, a standard medication in chemotherapy, can extend the lives of some patients who are battling the often fatal advanced HER-2 positive breast cancer.
Currently, the cure rate for early-stage breast cancer is high, and the safety and tolerability profiles of existing monoclonal antibodies (mAbs) are strong, Trewartha said. However, he said more advanced forms of the disease, such as metastatic cancer, are not as treatable.
“Due to the highly complex and polygenic nature of breast cancer, it is unlikely that the inhibition of a single target will be sufficient to substantially improve the prognosis in the clinic,” Trewartha said. “However, it is far more likely that the concurrent use of multiple targeted therapies, along with other available modes of therapy, will be able to do this, which will positively change the clinical landscape.”
Some of the various breast cancer drugs in development include a collaboration between NanoString , Astellas and Medivation . The three companies are developing a Phase III therapy for triple negative breast cancer, which currently has no recognized target for treatment. Patients typically rely on cytotoxic chemotherapy for standard care. Under the agreement NanoString will modify its PAM50-based Prosigna Breast Cancer Assay for potential use as a companion diagnostic test for enzalutamide in triple negative breast cancer. Enzalutamide is currently approved for the treatment of metastatic castration-resistant prostate cancer.
Puma Biotechnology is moving forward with a filing for its experimental drug PB272, also known as neratinib, for the extended adjuvant treatment of HER2-positive breast cancer. The company believes it will receive a New Drug Approval from the FDA this quarter. PB272 is a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.
Syndax Pharmaceuticals is developing a therapy for treatment-resistant breast cancer. Its lead product Entinostat is an oral, highly selective histone deacetylase (HDAC) inhibitor granted Breakthrough Therapy Designation in combination with hormone therapy in advanced hormone receptor positive (HR+) breast cancer. It is currently in Phase III testing for this indication.
