“Oncology continues to be a key area of focus for pharmaceutical manufacturers given the significant need for effective treatment options across a host of different types of cancer,” says Nadina Rosier, health and group benefits practice leader, pharmacy, Willis Towers Watson. “This year we are expecting at least 10 agents to be FDA approved for cancer indications, four of which are for breast cancer.”
These agents are oral all drugs and could cost at least $120,000 per patient per year, “placing significant pressure on healthcare executives to more aggressively manage the specialty pharmacy aspect of their medical and pharmacy benefit programs more tightly,” says Rosier.
Pipeline breast cancer therapies include abemaciclib, entinostat, and neratinib.
Lilly is seeking FDA approval for abemaciclib, a cyclin-dependent kinase-4 and cyclin-dependent kinse-6 inhibitor for refractory patients with hormone-receptor positive, human epidermal growth factor 2-negative (HER2) metastatic breast cancer. Approval is expected in the second half of 2017.
Abemaciclib is also being studied in non-small cell lung cancer (NSCLC).
Entinostat, an oral, small molecule histone deacetylase (HDAC) inhibitor, has direct effects on both cancer cells and immune regulatory cells, potentially enhancing the body’s immune response to tumors. Approval is anticipated this year with the proposed indication of treatment of postmenopausal women with advanced estrogen receptor-positive (ER+) breast
cancer who have progressed on a non-steroidal aromatase inhibitor. If approved, it would be given orally once weekly in combination with exemestane. Entinostat is also in phase 2 development for NSCLC, non-Hodgkin’s lymphoma and ovarian cancer.
Neratinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor in phase 3 development for the treatment of advanced breast cancer (including HER2+), as monotherapy and in combination with chemotherapy. At press time, approval of neratinib was expected in July 2017 for advanced breast cancer (including HER2+).
Unique approaches to overcoming tumor resistance is also being explored in the oncology space. “Certain cancers have been shown to accumulate high levels of hyaluronan [HA], a naturally occurring sugar in the body,” according to Helen Torley, president and CEO of biotechnology company Halozyme. “This accumulation creates a unique microenvironment that can foster the growth of tumor cells and create a barrier to drug delivery, inhibiting the potential effectiveness of many anti-cancer agents.”
Halozyme is seeking to target the tumor microenvironment with PEGPH20, its lead investigational drug currently being evaluated in multiple tumor types that accumulate high levels of HA, Torley says.
Earlier this year, Halozyme announced positive data from its phase 2 study, HALO-202, which evaluated PEGPH20 in combination with nap-paclitazel and gemcitabine in patients with advanced pancreatic cancer. Halozyme is partnering with other pharmaceutical companies to evaluate the pan tumor potential of PEGHP20 in combination with other therapies for the treatment of pancreatic, gastric and metastatic breast cancers.