Drug that Opens Doors
to a New Treatment Option

It is said that one in two Japanese people will be diagnosed with cancer at some point in their lives. For many years, the three main treatment options were surgery, anticancer drugs, and radiation.
In recent years, a fourth option has been added, namely, cancer immunotherapy, in which the body's natural immune system is strengthened to fight cancer.
Opdivo falls into this category of a cancer immunotherapy treatment.

A Rocky Start

“The road leading up to the launch of Opdivo was one full of repeated hardships and challenges.
But our team had been working with a single-minded determination to combat cancer that afflicts so many patients and their families.” says Mr.Yoshida as he reflects back on the project.
Soon after joining Ono Pharmaceutical, Mr.Yoshida participated in a joint research project with the laboratory of Tasuku Honjo, a distinguished professor at Kyoto University, who was working on a specific protein that would play a key role in Opdivo’s research, and Mr.Yoshida later became the Opdivo research project leader.

It was in 2002 that Dr.Honjo's laboratory identified this unique protein as the key to cancer immunity.
“We might be able to attack cancer with the power of the human body’s immune system.“
Based on this hypothesis, Mr.Yoshida and his team from ONO set out to work on creating a new drug to battle cancer.

However, at that time, ONO did not have the technology nor the facilities to produce such a new drug.
The team then attempted to reach out to various pharmaceutical companies, but the response they received was, “You should stop working on that kind of project as soon as possible.”
No company was willing to work with them.

After visiting probably more than a dozen companies, Mr.Yoshida finally found Medarex Inc., a U.S. venture company that had knowledge of cancer immunology.
The company began conducting joint research with Ono Pharmaceutical in 2005.
This is how an Opdivo-based drug candidate was first generated.

Never Give Up Hope

ONO still faced headwinds down the road, as the Company ran into difficulty starting clinical trials to confirm the efficacy and safety of drug candidates.
Cancer immunotherapy was known at the time as a form of treatment that lacked supporting evidence, and ONO had never even really worked on an anticancer drug before. Some physicians at the medical institutions that ONO requested cooperation for the clinical trial were even as critical to say, “It's upsetting that people (like you) believe that such a drug can reduce the size of cancer.”

Once we give up hope, the possibility for success disappears. Mr. Yukiya Oyama (currently the Senior Director, Oncology Clinical Exploratory Research) and his team, who were in charge of the clinical trial, persistently appealed to physicians about the drug candidate’s mechanism, thereby paving the way for the start of the clinical trial, which also began in Japan in 2008.

Developing Drugs While Thinking Outside the Box

One after another, patients with various forms of cancer were asked to participate in the clinical trial to see how well the drug candidate worked and to examine which cancer to develop the drug for.
Based on the data they gathered, the team decided to set their focus on rare cancers, which are rare in Japan but are extremely malignant and only had a limited number of drugs for treatment.
Mr. Gyo Sagara, then president of ONO , made the decision to develop the drug, and after further clinical trials were held, Opdivo was officially released in September 2014. “As long as there are patients who are suffering from diseases, we will do our best to deliver new drugs to those in need. That is our mission.”—said Mr. Sagara.

All the members involved in the project were full of emotions when Opdivo was released. “The fact that none of us had ever officially worked on a cancer drug before is what allowed us to think outside the box without any preconceived notions of what a cancer drug ‘should’ be and successfully develop Opdivo,” said Mr. Yoshida.
More than 20 years had passed since 1992, when the Honjo Laboratory at Kyoto University discovered the unique protein that would become key to Opdivo’s research.

In 2018, Dr. Honjo won the Nobel Prize in Physiology or Medicine for his discovery of cancer immunotherapy.
A variety of immune checkpoint inhibitors are now available on the market from other pharmaceutical companies, providing patients with more options for cancer treatment.

Patients’ Dreams

The success rate of a new drug hitting the market is said to be about 1 in 23,000*. With those kind of odds, what exactly is the driving force behind the development of new drugs?

Takao has been involved in a wide variety of studies.
When he hits a road block in his research, he makes a point to reassess the power that new drugs have.
New drugs have the power to help people eat better, realize their long-cherished dream, and spend more time with their family with a smile on their face.
There are many new drugs out there.
The more I hear about how new drugs are helping to enrich the daily lives of patients and their families around the world, the more I become convinced about
how we can provide hope and courage to patients as long as we keep taking on new challenges without giving up.