Biologics Build Oncology Drug Pipeline

MHE PublicationMHE November 2019
Volume 29
Issue 11

Phase 3 drugs show innovative approaches to cancer treatment.


Costs for oncology medications continue to increase in the U.S, with spending on all drugs reaching almost $150 billion in 2018. According to a study published in the Journal of Managed Care & Specialty Pharmacy, there are challenges for managing cancer drug costs even with new innovative technology tools. There are a variety of direct costs associated with treating cancer, which include physician visits, laboratory and imaging tests, radiation treatment, hospital stays, home care, and medication expenses. This article will discuss oncology drugs that are in phase 3 development and biosimilars on the horizon, as well as the financial impact of these medications.

Phase 3 oncology drugs in the pipeline

There are a variety of phase 3 drugs in the pipeline with some innovative approaches to cancer treatment. Celgene is planning to submit the biologics license application for lisocabtagene maraleucel (liso-cel) in the fourth quarter of 2019 for diffuse large B-cell lymphoma, the most common type of non-Hodgkin Lymphoma (NHL), with more than 18,000 individuals diagnosed annually. The ongoing phase 3 TRANSFORM (NCT03575351) trial is evaluating liso-cel in patients with B-cell NHL, and the expected study completion date is 2023.

Entinostat is being studied by Syndax Pharmaceuticals for the treatment of advanced hormone receptor-positive breast cancer, which has a novel mechanism of action as a histone deacetylase (HDAC) inhibitor. Evidence suggests that HDAC inhibitors can inhibit tumor growth, result in cancer cell death, and have little effect on normal tissue. Entinostat received Breakthrough Therapy status from the FDA after a phase 2 randomized placebo-controlled study demonstrated significant improvement in overall survival in combination with exemestane vs exemestane as monotherapy. Entinostat is currently being studied in a phase 3 trial (NCT02115282) including about 600 patients with recurrent hormone receptor-positive breast cancer, and the results are expected sometime in 2019.

Novartis is currently studying asciminib in patients with chronic myeloid leukemia through a phase 3 multicenter trial, with results expected in 2025. Asciminib has a novel mechanism of action in that it binds to a different site of the protein than tyrosine kinase inhibitors (TKIs) called the ABL1 myristoyl pocket, making it a promising option for patients that are intolerant/resistant to currently available TKIs.

Related: The Latest in the Hepatitis B Drug Pipeline

Biosimilar drugs and implications in therapy

Biosimilar approval may help to decrease oncology drug costs for patients as patent expirations of major biologics occur. According to Express Scripts, biosimilars could bring approximately $250 billion in savings by 2024. “Biologics have revolutionized oncology treatment modalities available to patients with serious health conditions in the last two decades,” says Jorge J. Garcia, PharmD, assistant vice president/System Oncology Pharmacy Service Line, Miami Cancer Institute/Baptist Health South Florida. Garcia says that biosimilars are defined as biologic agents that are not chemically identical, but are highly similar to an approved reference biologic agent.

Filgrastim-sndz, the first biosimilar FDA-approved and launched in the U.S., “has achieved and maintained market share in its drug class, providing discounts in the vicinity of 30%,” Garcia says. Long-acting granulocyte colony stimulating factor (G-CSF) biosimilars have most recently entered the market (e.g., pegfilgrastim-cbqv and pegfilgrastim-jmdb) driving discounts on highest cost G-CSF products. Additionally, there are more pegfilgrastim biosimilars expected to enter the market in the future, which could potentially further drive down costs.

“Bevacizumab-awwb and trastuzumab-anns are the first oncology therapeutic biosimilars to launch in the U.S. this summer, both of which are expected to make a significant dent on the oncology cost curve,” Garcia says. However, it is anticipated that providers will be more reluctant to use therapeutic biosimilars compared to supportive care biosimilars (e.g., G-CSF).  More significant cost savings are expected as several other bevacizumab and trastuzumab biosimilars enter the U.S. market in the near future. 

Jennifer Gershman, PharmD, CPh is a pharmacist and medical writer residing in South Florida.

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