With oncology agents now flooding the specialty drug pipeline, it is important to keep up with the latest developments and look ahead at innovative therapies on the horizon.
The cancer treatment landscape as evolved significantly in recent years, following the emergence of targeted novel therapies as game-changing players in the oncology field. With oncology agents now flooding the specialty drug pipeline, it is important to keep up with the latest developments and look ahead at innovative therapies on the horizon.
Highlights from the oncology pipeline were the focus of a presentation at the National Association of Specialty Pharmacy Annual Meeting and Educational Conference in Washington, DC. In the presentation, Cheryl Allen, BS Pharm, MBA, vice president of industry relations at Diplomat, discussed the rapidly changing market.
With the shift toward precision medicine, cancer treatments are now more targeted. Of more than 700 cancer agents in late- stage pipeline development, 33% are being studied with genetic testing and/or biomarkers that will be used to stratify patients for therapy, Allen said in the presentation. The emergence of chimeric antigen receptor (CAR) T-cell therapies represent an especially novel therapeutic approach.
“When we think about the ability to engineer a living cell to combat the patient’s cancer, it’s just groundbreaking,” Allen told Specialty Pharmacy Times® in an interview. To date, there are 2 FDA-approved CAR T-cell therapies: tisagenlecleucel (Kymriah) for acute lymphoblastic leukemia and axicabtagne ciloleucel for large B-cell advanced lymphoma. Another CAR T-cell product, lisocabtagene maraleucel (JCAR017, Celgene/Juno Therapeutics), is currently being evaluated for the treatment of diffuse large B-cell lymphoma.
Larotrectinib, slated for an approval decision by late 2018, would be the first drug approved by the FDA based on results from a basket trial, which is a study of a single mutation in a variety of tumor types. Larotrectinib is being evaluated for various tropomyosin receptor kinase—positive (TRK+) genetic mutation cancers.
Allen also mentioned significant devel- opments in the treatment of prostate cancer. “With prostate cancer, by the time that we get to see these patients, many times they are castration resistant,” she said. “So we are beginning to see more therapies that maybe don’t have as much of a [central nervous system] side effect.”
Abiraterone (Zytiga) was approved for a label expansion in February 2018 for metastatic high-risk castration-sensitive prostate cancer based on data from the LATITUDE trial. Other new approvals include apalutamide (Erleada) and a new formulation of abiraterone (Yonsa) via the 505b2 pathway. This approval allows Yonsa to be taken with or without food; Zytiga requires the medication to be taken on an empty stomach.
Darolutamide and ipatasertib, both in phase 3 pipeline development, are anticipated for decisions on their approval by 2019 and 2020, respectively.
Allen cited specialty oncolytic approvals to keep an eye out for toward the end of 2018 and beyond (TABLE).
Statistics show that 38% of individuals will have cancer at some point in their lifetime, according to Allen. Additionally, US spending in 2017 on cancer medications and supportive care was $50 billion and costs are estimated to rise even further. The combined incidence and spend presents a sobering outlook, especially as patients with cancer, who are living longer with their diseases, must face the long-term financial burden.
However, the entrance of specialty generics into the space provides an opportunity to reduce the cost burden for some of these treatments. Allen noted the importance of closely monitoring emerging biosimilars and generics. Recently approved oncolytic biosimilars include trastuzumab-dkst (Ogivri, Mylan), epoetin alfa-epdx (Retacrit, Pfizer), pegfilgrastim-jmdb (Fulphila, Mylan), and filgrastim-aafi (Nivestym, Pfizer). Furthermore, the loss of brand exclusivity for Zytiga will likely mean the launch of a generic abiraterone in the future, Allen noted.
As new cancer therapies continue to reach the market, health care professionals will play a crucial role in ensuring that therapies are appropriately utilized and patients remain adherent over time.