Eisai's Chief Scientific Officer Says “I Was One of Those Families”

ArticleResearch

Sep 13

Article for Blue Faery by Kenichi Nomoto
Interviewed by Cindy Gessell, Senior Consultant, Eisai Inc.

Thirty-five years later, driven by personal and professional passion, Dr. Kenichi Nomoto expands the liver cancer treatment landscape.

Kenichi Nomoto, Ph.D., Chief Scientific Officer, works in the Oncology Business Group at Eisai. Dr. Nomoto has always been passionate about developmental biology for professional and personal reasons. As an undergraduate student, this interest led him to pursue a career in research. In 1984, Dr. Nomoto joined Eisai where he worked as a bench scientist for discovery research in cardiovascular diseases. This opportunity guided him to learn more about vascular biology. This area led to the development of LENVIMA® (lenvatinib), a prescription medicine that is used by itself for a type of liver cancer, Hepatocellular Carcinoma (HCC) when it cannot be removed by surgery.

What drove your passion for oncology?

Eisai has a unique corporate philosophy. We call it our human health care (hhc) mission, which means we give our first thoughts to patients and their families. This philosophy inspires and motivates us to create and deliver new medicine for people who are suffering from diseases. In 1999, I was one of those families. My father passed away after a two-and-a-half-year battle with HCC. At that time, there was a lack of systemic therapeutic options for unresectable advanced HCC. My family and I lived through a very difficult time while he was suffering. I recognized that there was a strong unmet medical need for the treatment of this disease.

Coincidentally, the LENVIMA project commenced in 1999 in Eisai Tsukuba Research Laboratories in Japan. Eisai gave me the unique opportunity to work on this project as a biology co-leader for discovery research in 2000. In 2018, sixteen years after we selected the molecule, our dream came true. The U.S. Food and Drug Administration approved LENVIMA as the first new first-line systemic treatment option for patients with unresectable HCC in over a decade.

Can you share how LENVIMA was discovered in the laboratory?

In the 1990s, cytotoxic chemotherapy, which kills cancer cells, was the common therapeutic option for cancer treatment. As cytotoxic agents inhibit cell division, they may also damage normal cells. Since cytotoxic agents are not able to tell the difference between healthy and malignant cells, it is often difficult to balance the treatment benefit versus the wide variety of adverse events.

In the early 1970s, Dr. Judah Folkman at Children’s Hospital in Boston hypothesized that tumors could not grow beyond a certain size without a blood supply. They must have some mechanism to create the formation of blood vessels. At first, researchers neglected his theory; they focused on chemotherapy. A crucial moment came in the late 1980s with the discovery of vascular endothelial growth factor (VEGF). It is a protein that blocks the growth and development of vascular cells that form new blood vessels.

These new scientific discoveries gave us the idea to test VEGF-targeted therapy in the laboratory. The goal was to extend the overall survival of patients living with cancer while maintaining a safety profile that may be manageable. HCC is characterized by a well-developed tumor vascular network, which provides the rationale for VEGF-targeted therapies for the treatment of unresectable HCC. In 1999, the oncology community was still skeptical that blocking the growth and development of these cells could be a viable cancer treatment option. Yet, our team, led by Eisai researchers Drs. Akihiko Tsuruoka and Yasuhiro Funahashi, pursued this therapy.

In 2007, treatment was approved in the United States and Europe for advanced HCC. Since then, several medicines have been tested with unsuccessful results for more than 10 years, until LENVIMA. LENVIMA is used by itself as a treatment for HCC when surgery cannot remove the tumors.

Today, besides becoming a treatment option for unresectable HCC in the U.S., LENVIMA has also been approved to treat advanced liver cancer in the European Union, Japan, South Korea, China, Taiwan, Australia, Canada, and several other countries. We hope that more countries will use it in the future.

On behalf of the Eisai research team, I am very grateful for all the patients, their families, and health care providers who participated in the clinical trials. Our Eisai research team promises to continue research on LENVIMA so that we may provide more benefits to appropriate patients. As part of Eisai’s human health care mission, we work to satisfy unmet medical needs and contribute to the health and well-being of people living with unresectable liver cancer.

IMPORTANT SAFETY INFORMATION

LENVIMA may cause serious side effects, including:

high blood pressure (hypertension): High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose of LENVIMA, or stop your treatment with LENVIMA.
heart problems: LENVIMA can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles.
problem with blood clots in your blood vessels (arteries): Get emergency medical help right away if you get any of the following symptoms: severe chest pain or pressure; pain in your arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; sudden severe headache; sudden vision changes.
liver problems: LENVIMA may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you have any of the following symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark, “tea-colored” urine; light-colored bowel movements (stools); feeling drowsy, confused, or loss of consciousness.
kidney problems: Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your healthcare provider should do regular blood tests to check your kidneys.
increased protein in your urine (proteinuria): Proteinuria is a common side effect of LENVIMA and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with LENVIMA. If you develop protein in your urine, your healthcare provider may decrease your dose of LENVIMA or stop your treatment.
diarrhea: Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare provider or go to the emergency room if you are unable to drink enough liquids and your diarrhea is not able to be controlled.
an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula): Get emergency medical help right away if you have severe stomach (abdomen) or chest pain.
changes in the electrical activity of your heart called QT prolongation: QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an ECG.
low levels of blood calcium (hypocalcemia): Your healthcare provider will check your blood calcium levels during treatment with LENVIMA and may tell you to take a calcium supplement if your calcium levels are low.
a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Call your healthcare provider right away if you get a severe headache, seizures, weakness, confusion, blindness, or change in vision.
bleeding: LENVIMA may cause serious bleeding problems that may lead to death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment with LENVIMA, including severe and persistent nose bleeds; vomiting blood; red or black (looks like tar) stools; blood in your urine; coughing up blood or blood clots; heavy or new onset vaginal bleeding.
change in thyroid hormone levels: You may have changes in your thyroid hormone levels when taking LENVIMA. Your healthcare provider may need to change your dose of thyroid medicine while you are taking LENVIMA. Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA.
wound healing problems: If you need to have a surgical procedure, tell your healthcare provider that you are taking LENVIMA. LENVIMA should be stopped until your wound heals.

The most common side effects of LENVIMA in people treated for thyroid cancer include tiredness; joint and muscle pain; decreased appetite; weight loss; nausea; mouth sores; headache; vomiting; rash, redness, itching, or peeling of your skin on your hands and feet; stomach (abdomen) pain; and hoarseness.

The most common side effects of LENVIMA in people treated for kidney cancer include tiredness, joint and muscle pain, decreased appetite, vomiting, nausea, mouth sores, swelling in your arms and legs, cough, stomach (abdomen) pain, trouble breathing, rash, weight loss, and bleeding.

The most common side effects of LENVIMA in people treated for liver cancer include tiredness; decreased appetite; joint and muscle pain; weight loss; stomach (abdomen) pain; rash, redness, itching, or peeling of the skin on your hands and feet; hoarseness; bleeding; change in thyroid hormone levels; nausea.LENVIMA may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.These are not all the possible side effects of LENVIMA.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information.
Learn more about the Eisai Assistance Program and other support at www.LenvimaReimbursement.com or by calling 1-866-61-EISAI (1-866-613-4724).
For more information about LENVIMA please see available full Prescribing Information.