Oncology

The American Society of Clinical Oncology’s (ASCO) annual meeting, held June 1-5, 2018, in Chicago, Illinois, featured results of numerous studies on biosimilars in anticancer and supportive care. Here are 5 key takeaways from the meeting.

The Center for Biosimilars® recaps the top 5 articles for the week of June 4, 2018.

During a session at the 2018 American Society of Clinical Oncology Annual Meeting, held June 1-5 in Chicago, Illinois, researchers gave a glimpse into new directions in oncology biosimilars through providing results on several studies testing the safety, efficacy, and usage of different biosimilars.

During the 2018 American Society of Clinical Oncology Annual Meeting, researchers published new findings on the use of rituximab in mantle cell lymphoma (MCL) as well as the outcomes of patients who relapse early after treatment with rituximab for diffuse large B-cell lymphoma (DLBCL).

Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.

Research published in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting presented new findings on the use granulocyte-colony stimulating factor agents in treating febrile neutropenia (FN) and in peripheral stem cell mobilization.

The FDA has approved Mylan and Biocon’s pegfilgrastim biosimilar, pegfilgrastim-jmdb. The product, the first biosimilar pegfilgrastim approved in the United States, will be sold under the brand name Fulphila.

On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.

During the 2018 American Society of Clinical Oncology's Annual Meeting, researchers presented findings on 3 biosimilar trastuzumab products: Samsung Bioepis’ SB3, Agmen’s ABP 980, and Biocad’s Herticad.

On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.

This week, the Community Oncology Alliance (COA), which represents approximately 5000 community oncologists, announced that it has filed a lawsuit against HHS, HHS Secretary Alex Azar, the Office of Management and Budget (OMB), and the director of the OMB, Mick Mulvaney, in the District of Columbia to stop the departments from applying the Medicare sequester cut to reimbursement for Part B drugs.

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Researchers involved in the Persephone phase 3 randomized clinical trial of 4089 women with HER2-positive early breast cancer found that 6 months of trastuzumab treatment was not inferior to the current standard.

Some cervical cancer patients with advanced or recurrent disease suffer from anaphylaxis after taxane- or platinum-based therapy, and there is no standard treatment for progressive disease that develops during or shortly after platinum-based chemotherapy. Doctors and patients have therefore sought the development of a non-taxane, non-platinum regimen for recurrent cervical cancer.

While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.

Trastuzumab competition in the European market is heating up, as Mundipharma announced yesterday that it has officially launched Celltrion’s biosimilar, Herzuma.

A case series was recently published in CNS Oncology that investigated whether adult pilocytic astrocytoma—a rare and highly vascular tumor—is responsive to bevacizumab treatment.

Pfizer announced this morning that the FDA has issued a Complete Response Letter for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin.

Last time on the podcast, we spoke with a practicing rheumatologist about his experience with biosimilars so far, but one of the most exciting prospects on the biosimilars horizon is the market entry of 2 approved anticancer biosimilars: trastuzumab and bevacizumab. This week, we’re delving into the world of supportive care and anticancer biosimilars with an oncology expert, Robert M. Rifkin, MD, FACP.

During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland, Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, highlighted the opportunities biosimilars provide to increase access to drugs while decreasing costs, but also the remaining barriers to adoption.

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.

Researchers demonstrated that trastuzumab increased progression-free survival (PFS) in patients with uterine serous carcinoma.

A recent study concludes that both hypertension and proteinuria, which are considered to be interrelated with the pharmacological action of bevacizumab, have the potential to indicate greater likelihood of therapeutic efficacy.

Today, Celltrion announced that the FDA has issued Complete Response Letters (CRLs) for 2 of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin.

In a recently published study, researchers sought to determine the cost effectiveness of bevacizumab in treating recurrent ovarian cancer from a Canadian public payer perspective.

Linda Frisk, PharmD, of Arizona Oncology, discusses biosimilars and cost savings.

March 2018 saw a variety of developments for biosimilars in cancer care, both in the United States and abroad.

Eflapegrastim is novel long-acting granulocyte-colony stimulating factor therapy. Pharmacokinetic analysis in vivo demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when administered at similar doses, and the proposed drug demonstrated comparable efficacy compared with pegfilgrastim in an open-label study in patients with breast cancer who were receiving docetaxel and cyclophosphamide.

During a symposium held during the 23rd annual conference of the National Comprehensive Cancer Network (NCCN), held last week in Orlando, Florida, Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center; Jeffrey Crawford, MD, of Duke University; and Lee Schwartzberg, MD, FACP, of University of Tennessee Health Science Center, presented on the use of biosimilars in oncology.

Howard Cohen, RPh, MS, FASHP, director of oncology pharmacy services for Yale New Haven Hospital, discusses using biosimilar filgrastim.