Roche Korea, the number one company in the domestic anticancer market, is leading the way in addressing the unmet medical needs, by providing optimal options for patients throughout their treatment cycle with various innovative drugs.

The company is well known among local patients and physicians for its anticancer drugs such as Herceptin and Tecentriq. Rather than enjoying its position as the top seller in the anticancer field, however, the company is continuing to make innovative measure to deliver new and safe treatment options for patients quickly.

The company believes its continued effort to make innovation is part of what it is, which is why its global corporate mission is "doing now what patients need next."

Korea Biomedical Review met with Roche Korea's Medical Director Kim Su-jeong to discuss what pipelines that the company has in Korea and its efforts to address areas with high unmet medical needs.

Roche Korea Medical Director Kim Su-jeong explains the company’s various anticancer pipelines, at the company’s headquarters in Gangnam-gu, southern Seoul, last Tuesday.

Question: What are the anticancer pipelines marketed by Roche Korea?

Answer: There are 11 anticancer drugs that we currently market to treat various cancers, including breast, lung, and bladder cancer, in Korea. With such robust pipelines, we have been the No. 1 seller in anticancer medication in Korea for the past several years.

Recently, with the rising hype of precision medicine or personalized care, we are working with Korean doctors to ensure individual patients achieve optimal treatment results in the whole treatment cycle from diagnosis and treatment to monitoring.

Q: Roche has a strong presence in the lung cancer area. What are some treatment options that the company provides for patients?

A: Roche Korea's provides a variety of innovative lung cancer treatment, including Alecensa, an anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), Tecentriq, the first anti-PD-L1 immunosuppressive drug in the NSCLC, and Tarceva, an epidermal growth factor receptor for NSCLC drug.

Notably, Tecentriq is the first immunotherapy in Korea to receive reimbursement as a second-line treatment for NSCLC and urothelial carcinoma regardless of PD-L1 expression.

Q: Tecentriq is a latecomer in the local immunotherapy stage. What are its differences and strengths compared to other immunotherapies?

A: Although we are latecomers, we have focused on cancers that have high unmet medical needs from the development stage. Such areas include small cell cancer (SCLC), triple-negative breast cancer and bladder cancer, which are all areas that have had limited development for innovative treatments or poor treatment results.

The company has started producing excellent results and can say for sure that we are the leading the way in addressing the needs of patients from such rare cancers.

Also, the company has been fully utilizing its understanding of cancer biology and immunology and has focused on developing a combination treatment that combines Tecentriq with existing cytotoxic drugs. As the company has a broad pipeline, we have already developed several combination treatments that can better treat patients.

In the field of SCLC where there were no treatment options other than chemotherapy for 20 years, Tecentriq has recently become the only immunotherapy approved as a first-line treatment by the U.S. Food and Drug Administration.

Roche plans to receive approval for the indication in Korea as soon as possible as the company is committed to delivering the clinical benefits of immunotherapy to more patients more quickly.

Q: What are some other cancers that Roche Korea is focused on?

A: Breast cancer is a significant part of the company's pipeline. From early breast cancer to metastatic breast cancer, we offer treatment options tailored to patient characteristics in all aspects of breast cancer treatment. Our pipeline includes the world's first HER2-positive breast cancer treatment drug Herceptin, the first-line therapy for HER2-positive early breast cancer, metastatic breast cancer Perjeta, and the first antibody-drug conjugate (ADC) Kadcyla.

Herceptin is considered a pioneer in the HER2-positive breast cancer treatment area by changing the paradigm of breast cancer treatment.

The company continues to make innovations and deliver a wide range of targeted treatment options, including Herceptin SC, to improve breast cancer patients' quality of life and further cure the disease. Perjeta has recently received selective reimbursement in treating early breast cancer patients in Korea, thereby increasing the patients' access to the treatment.

Roche Korea is also conducting various trials to treat triple-negative breast cancer and hormone-positive breast cancer.

Q: Recently, a lot of pharmaceutical companies are developing ADCs treatment. What are Roche's strengths in the area?

A: Roche has developed Kadcyla, the first ADC treatment for breast cancer, to improve such quality of life of patients with poorly treated breast cancer due to the toxicity of chemotherapy.

Kadcyla binds to the HER2 receptor on the surface of the cancer cell and enters into tumor cells, where it is broken down. During the process, it isolates the cytotoxic anticancer drug, inhibits tumor cells proliferation, and destroys cancer cells to reduce normal cell damage during chemotherapy.

The company is also developing a new ADC treatment called Polivy for lymphoma patients who have been previously treated with other drugs. The FDA designated Polivy as a breakthrough therapy in 2017 and received accelerated approval from the U.S. agency in 2019.

Q: Roche Korea also faces biosimilar competition for Herceptin. Does the company have any strategy against biosimilar products?

A: We don't have a strategy per se. The company's stance is similar to global headquarters. We believe that biosimilars, in general, is a good thing as it creates room for innovation. At the same time, however, they have to be held to the same standards as the original treatment, such as delivering the same therapeutic effect to patients.

Q: Regarding Roche’s clinical trial activities, where does its Korean branch stand globally?

A: Roche Korea established its clinical trial division in 1997 and has been conducting clinical and research and development (R&D) activities in this country for more than two decades.

The company was also named one of 22 foreign branches that introduce and lead the global R&D strategy and clinical projects in 2014. Therefore, it is safe to say that the company plays a vital role in implementing and attracting global R&D strategies.

Roche Korea is participating in about 44 percent of Roche's global clinical trials.

Q: What are some of the clinical trials being conducted in Korea?

A: We have conducted more than 300 clinical trials in Korea, and more than 70 percent of the trials are for anticancer drugs.

In the global clinical trials of major anticancer drugs such as Herceptin, Perjeta, and Alecensa, Korea is one of the top three nations with high patient enrollment.

Roche Korea is also one of 10 foreign offshoots participating in Roche's global R&D network of immunocancer drugs and is leading the participation of many Korean patients and medical staff in the development of innovative medicines.

Q: What are the positive aspects of conducting clinical trials in Korea?

A: The positive aspect is that Korea is becoming more and more known for its capacity to conduct clinical trials, as both the government and research institutions are publishing a lot of results clinical trials conducted in Korea.

Also, it is essential to note that the Ministry of Food and Drug Safety, and researchers continue to discuss how to improve the Korean clinical environment and enhance competitiveness.

The company's global headquarters is well aware of such facts.

Q: Will Roche continue to increase clinical trials in Korea?

A: Yes. We will try to bring more clinical participation opportunities in the field of anticancer drugs and rare diseases so that address the unmet medical need of Korean patients.

corea022@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>