Astellas Pharma recently announced it would transform into an oncology drug developer and started reorganizing units and building pipelines for anticancer drug development.

In line with the headquarters’ business direction, Astellas Korea also completed the reorganization of the oncology division to focus on prostate cancer treatment Xtandi (enzalutamide) and acute myeloid leukemia (AML) drug Xospata (gilteritinib).

The Korean offshoot said 2022 would be the first year the company “leaps forward to become an oncology drug specializing firm” and gears up to grow critical products.

Korea Biomedical Review met with Kim Jin-hee, director of Astellas Korea’s Oncology Business Unit, to learn about the goals and business direction of the oncology unit.

Kim is an oncology drug specialist who started with the sales of breast cancer medicines at Roche Korea and handled marketing in various cancer types such as lung cancer, liver cancer, gastric cancer, colorectal cancer, and blood cancer. She joined Astellas Korea in 2021 and led the company’s sales marketing and sales planning.

Question: Last year, Astellas Korea underwent a significant reorganization centering on anticancer drugs. How is the oncology business unit structured?

Answer: The oncology business unit started to take shape when prostate cancer drug Xtandi and AML drug Xospata were added. Astellas Korea has had a solid leadership in urinary diseases, but we just started to push for the oncology business. So, we actively scouted experts in cancer drugs. Our oncology business unit consists of over 20 people. We hope that those talented people with expertise in various areas from Roche, Novartis, and Sanofi will maximize the synergy.

Q: Can you introduce Xtandi and Xospata?

A: AML is a fatal disease. About 90 percent of the patients die within a year if left untreated. The demand for more treatment options was very high because AML patients received chemotherapy, which developed in the 1970s until recently. Those who are positive for FLT3 mutation and do not respond to chemotherapy have difficulty in treatment. However, the release of Xospata in Korea in 2020 significantly improved survival rates. The drug became reimbursable recently, which further improved access to treatment.

Xtandi became a blockbuster drug because it expanded indications in the prostate cancer area where treatment options were lacking. It initially obtained the license as a second-line treatment for early metastatic castration-resistant prostate cancer.

It expanded as a first-line therapy to treat non-metastatic castration-resistant and hormone-responsive metastatic prostate cancer. It became the only monotherapy used in all metastatic, non-metastatic, castration-resistant, and sensitive prostate cancer. Many elderly patients with prostate cancer cannot tolerate the side effects of chemotherapy, but Xtandi showed excellent effects while maintaining the quality of life of patients. Xtandi is a symbolic item at the starting point of Astellas Korea’s oncology business unit.

Q: Expanding reimbursement for both Xtandi and Xospata will be an essential issue for the company.

A: Xtandi, in combination with an anti-androgen drug in hormone-responsive metastatic prostate cancer (mHSPC), recently passed the Health Insurance Review and Assessment Service’s (HIRA) cancer drug review committee, the first step for getting health insurance benefits. The existing treatment option was reimbursable only for high-risk mHSPC patients whose disease progressed considerably. As Xtandi can be used in all-comer patients, regardless of the risk level, we are expecting positive results.

This year, our primary goal is to complete all the remaining procedures for Xtandi’s broader reimbursement. After that, we will prioritize providing the insurance benefits to patients quickly and offering accurate information on drug data to patients and physicians.

Q: Xosapata recently became reimbursable, but physicians are unhappy about the limitation of the reimbursable period.

A: Xospata became a new treatment option for patients with FLT3 mutation-positive relapsed/refractory AML. Two years after winning the permit, it got health insurance benefits and lowered the treatment barrier. But I feel very sorry that the reimbursable period was limited to four cycles. The company also collects regretful voices from patients, families, and physicians.

As Xospata got insurance benefits from March. So, by June or July, patients will have to discontinue Xospata treatment due to the end of the reimbursement period. The company continues to discuss with the government to help Korean AML patients get treatment benefits within the health insurance coverage.

Q: What are Astellas’ oncology pipelines, which will be introduced in Korea later?

A: Recently, the European Commission authorized Padcev (enfortumab vedotin), a urothelial cancer drug. We are closely working with related officials to roll out the treatment in Korea. Although there are many treatment options for the first- and second-line treatment of metastatic urothelial cancer, there is still an unmet need for the third- or higher-line treatment.

Padcev is an antibody-drug conjugate (ADC) that targets Nectin-4, a protein located on the surface of cells highly expressed in urothelial cancer. It is recommended as a Category 1A drug in the international guidelines by the U.S. National Comprehensive Cancer Network and the European Society for Medical Oncology. We are making efforts to help Korean urothelial cancer patients benefit from the new drug.

A monoclonal antibody, zolbetuximab, which targets Claudin 18.2 in gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer, is in the clinical stage.

We are also conducting clinical studies in various carcinomas, closely cooperating with the headquarters to introduce innovative new drugs for local patients as soon as possible.

Q: Can you give us a global outlook of Astellas’ oncology business?

A: Astellas ranks within the top 20 multinational pharmaceutical companies in net profit as of 2021. It is also solidifying its status as an oncology drug company. According to the 2022-2028 global anticancer market outlook by Market Research, Astellas was one of the 15 major anticancer companies, along with Roche, Novartis, and BMS. Fierce Pharma forecast that Astellas would become the 10th largest oncology drug company in 2024. This shows that anticancer medicines will drive Astellas’ growth.

Our company invests about 18 percent of the annual revenue in R&D. By putting “Science First” as the highest value, we strive to develop more sophisticated new oncology drugs and build strategic partnerships with prestigious medical institutions and companies to accelerate new drug development.

Q: Many other drugmakers also aim to be oncology-specializing companies. What makes Astellas unique?

A: Astellas’ oncology portfolio mainly focuses on fatal cancers with poor prognosis and those that require urgent expansion of treatment options for higher survival. Regardless of the size of the business, Astellas’ effort to improve treatment access for patients with highly unmet medical needs is significant. Developing innovative therapeutics for underserved cancer patients and wanting to become a companion is why the oncology business unit exists at Astellas, which sets us apart from other companies.