Takeda Pharmaceuticals Korea launched a new oncology business unit in 2019, following the global headquarters’ policy to focus on four core treatment areas – oncology, gastroenterology, neuroscience, and rare diseases.

However, the outlook for the oncology business dimmed when the Covid-19 pandemic hit the globe last year.

Despite the pandemic headwinds, however, the Korean offshoot of the Japanese pharmaceutical company successfully won local approval and health insurance benefits for key anticancer drugs.

Korea Biomedical Review has met Kim Jung-hun, head of oncology at Takeda Pharmaceuticals Korea, who has been leading the oncology unit since 2019, to hear about current issues of Takeda’s major oncologic medicines, how the company went through the Covid-19 crisis, and the value of operating the oncology business unit.

Question: Can you briefly explain Takeda Pharmaceuticals Korea’s major oncology portfolio?

Answer: Ninlaro (ingredient: ixazomib), multiple myeloma (MM) treatment, is what the company rolled out most recently. As the first oral proteasome inhibitor (PI), the drug won health insurance benefits in March. Ninlaro is not only more effective than conventional treatments but highly convenient as oral medicine. Many MM patients are high-risk and elderly, and Ninlaro has a strong competitive edge as an oral drug as it can minimize hospital visits in the era of Covid-19.

Ovarian cancer drug Zejula (niraparib) obtained the regulatory nod in 2019 as a PARP inhibitor. In the past, reimbursement was allowed only for patients with platinum-sensitive recurrent germline BRCA-mutated ovarian cancer aged 18 or older in the second-line or higher maintenance therapy. Since February this year, however, the government expanded the insurance benefits for the fourth or higher treatment for patients with BRCA mutation and the second-line or higher maintenance treatment for those with BRCA mutation. Zejula showed clinical benefits regardless of BRCA mutation compared to existing drugs.

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) non-small cell lung cancer (NSCLC) treatment. It got the insurance benefits for the second-line treatment in 2019, and the benefits were expanded for the first-line or higher treatment in April. ALK-positive NSCLC patients often have brain metastasis at diagnosis, and brain metastases frequently occur during treatment. So, the risk of death is very high for these patients. Alunbrig is a second-generation treatment that showed excellent efficacy in patients with brain metastases.

Lastly, I want to introduce Adcetris (brentuximab vedotin), which is the first product rolled out by the oncology unit of Takeda Pharmaceuticals Korea. Adcetris is an antibody-drug conjugate (ADC) and is used to treat Hodgkin's lymphoma, CD30-positive peripheral T-cell lymphoma, systemic anaplastic large cell lymphoma, and CD30-positive cutaneous T-cell lymphoma. The government broadened the insurance benefits as a primary treatment for certain adult lymphoma in April.

Q: It seems that the company needs expanded benefits for Zejula first, among the pending issues for Takeda’s drugs. Do you agree?

A: The Health Insurance Review and Assessment Service (HIRA)’s cancer drug review committee passed the proposal to give reimbursement for Zejula as the first-line maintenance therapy, and we are waiting for the drug reimbursement evaluation committee to discuss it. Until recently, in the first-line treatment, patients had no other choice but to wait and see until an injection treatment becomes available or there is a recurrence. So, there is a large unmet need for therapy to prevent recurrence in an earlier-stage treatment.

Although Zejula was effective in ovarian cancer without BRCA mutation and won the license to treat ovarian cancer patients regardless of BRCA mutation, the reimbursement scope is limited. In real clinical settings, doctors say that the unmet need is very high. In the future, we plan to add new data from real clinical settings and request a review by the health authorities. I hope we will get positive results.

Q: Alunbrig started to compete against rivals in earnest after it won insurance benefits in the first-line treatment. Do you have a specific strategy to broaden its market share?

A: Alunbrig already has good data for all patients, but its effect was particularly strong in patients with lesions in the central nervous system compared to existing treatments. In the ALTA-1L study, Alunbrig improved the risk of disease progression or death by about 51 percent compared to crizotinib, the first-generation treatment. The median progression-free survival evaluated by the investigator was 29.4 months, three times that of crizotinib at 9.2 months. In patients with brain metastases, Alunbrig lowered the risk of intracranial disease progression or death by about 69 percent and showed excellent therapeutic effects differentiated from those by existing second-generation treatments.

Alunbrig has strength in long-term safety, too. As patients can take one tablet once daily, the medicine improves the quality of life, and these benefits are clear. Based on these clinical benefits, the company expects Alunbrig to become the standard of care in the ALK-positive NSCLC market. We aim to become a leader in the market, and we hope that we will achieve the goal without a big problem.

Q: How did the oncology unit win more approval and reimbursement last year, even when marketing and sales activities were greatly limited due to the Covid-19 pandemic?

A: The oncology division achieved remarkable outcomes despite Covid-19 because we had a “3P” strategy – patient, people, and product. The first P represents “patient-centered” service. We most wanted to avoid a situation where patients can’t get appropriate treatment options or life support due to limited information delivery.

To overcome the difficulty of providing the latest medical information through a face-to-face visit, we built an “Omni-Channel” to provide medical information through KakaoTalk or email. The most important thing in operating the channel was the consent of doctors. In the oncology unit, the consent rate at the beginning of last year was 10-20 percent but went up to 50-60 percent now. This year, we plan to strengthen information delivery through remote meetings as well as face-to-face visits.

The second P is the resilience and flexibility of our “people” (employees). We can call it “resilience leadership.” Rather than giving up efforts to hold offline symposiums, we tried to develop various channels and conducted symposiums in a virtual or hybrid method while taking full advantage of new technologies to quickly adapt to the changing environment.

The last P is the innovative and competitive “product.” The oncology business unit solidified Takeda’s footings by winning approval for Alunbrig and Zejula for the first-line treatment, insurance benefits for Ninlaro, and expanding reimbursement for Adcetris.

This “3P” strategy was the key to overcome the pandemic crisis. Doctors also positively evaluated Takeda Pharmaceuticals Korea’s activities last year.

We could keep this momentum and yield good results this year, too.

Q: What are the major pipelines of global Takeda, and for which drug do you seek to win the local license?

A: Takeda focuses on four core treatment fields -- oncology, gastroenterology, neuroscience, and rare diseases. Among the four, oncology is mentioned first. The local regulations make it difficult to say detailed items publicly. So, let me introduce them by naming target diseases. I expect that our lung cancer-targeting drug to arrive first. Takeda is preparing an NSCLC treatment that targets a rare mutation that has not been developed. The next runner could target the leukemia area.

Also, we are making efforts to introduce medicines with various mechanisms in all areas of solid cancer and blood cancer, including prostate cancer-related hormone therapy and blood cancer-related cell treatment. We will endeavor to provide new treatment options for Korean cancer patients quickly.