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This is the “most exciting moment” in Daiichi Sankyo’s 100-year history, said Ken Keller, CEO and president of the company’s U.S. operations and head of global oncology. .
Buoyed by the success of its blockbuster cancer drug Enhertz, which partnered with AstraZeneca, the company announced a partnership with Merck & Co. in October. up to $22 billion. And with new approvals likely this year, Plant No. 1 is on track to become a cancer powerhouse ahead of its own schedule.
The company, which was formed in 2005 through the merger of two long-established Japanese pharmaceutical companies, Sankyo and Daiichi Pharmaceutical, has been “heart-centric” for most of its history, Keller said. It is now Japan’s second-largest pharmaceutical company, and its diverse portfolio also includes vaccines and migraine drugs.
However, Daiichi launched Enhertu for HER2-positive unresectable or metastatic breast cancer in 2020, turning its attention to oncology and vowing to become a “top 10 cancer pharma company” within 10 years.
“It was a big ambition from scratch,” Keller said. “Five years later, we have changed the way cancer is treated.”
The company’s special sauce is its proprietary antibody-drug conjugate platform called DXd, which is used to develop six candidates against multiple cancers. Since its initial approval for breast cancer, Enhertu has racked up approvals for several other HER2-related indications. This includes the first approval of his tumor-independent ADC. FDA approved During April.
Daiichi and its Enhertz development and commercialization partner AstraZeneca also recently announced positive top-line results from a Phase 3 trial in patients with low HER2 protein levels. Result is, the company said Demonstrating a “statistically significant and clinically meaningful benefit” in progression-free survival could help move ADCs into earlier lines of treatment.
Ken Keller, CEO and President of Daiichi Sankyo Co., Ltd.Head of Global Oncology
Permission from Daiichi Sankyo Co., Ltd.
Meanwhile, the company has three important PDUFA dates coming up within nine months. In June of this year, the FDA is expected to make the following decisions: HER3 treatment Currently part of three treatments for non-small cell lung cancer Collaboration with Merck. The agency is also expected to announce a decision on the TROP2-oriented ADC that Daiichi is co-developing with AstraZeneca. At NSCLC December of this year and beyond breast cancer In January 2025.
Keller said that if approved, Daiichi would be poised to become a “top 10 cancer company” by fiscal 2026.
There’s a lot of competition. Pfizer acquires her ADC specialist as ADCs become one of the pharmaceutical industry’s most popular products Seagen, $43 billion acquisition last year.But the first is scheduled Monopolize the ADC market According to GlobalData analysis, it will record the highest level of sales until 2029.
Here, Keller discusses Enhertu’s growth prospects and how ADCs could one day become a curative therapy in cancer treatment.
This interview has been edited for brevity and style.
Pharmavoice: Enhertz’s sales more than doubled last year, from about $1.25 billion in 2022 to $2.5 billion. Please tell us about the long-term prospects for this drug.
Ken Keller: Today we will look at five signs that we received. We just announced a positive pivotal trial for another indication in the HER2-low space (and) a very surprising potential indication. This study looked at its use as an alternative to chemotherapy, rather than post-chemotherapy, and also demonstrated efficacy in the ultra-low HER2 setting.
If you look at breast cancer, HER2-positive is about 20% of cases, HER2-low is about 50%, and if you include very low, it can help nearly 90% of women with breast cancer. It would be the greatest treatment ever for breast cancer. That will give you an idea of where the program is heading.
Enherz is a huge drug for Daiichi, but is the company relying too much on this single drug for future growth?
Enhertu is the foundation of everything we do. We currently have an ADC in development with Merck and AstraZeneca, and we have two other DXd treatments in the clinic, leveraging our leadership in ADCs. We are currently working on second- and third-generation treatments.
We have seen clear growth over the last 10 years, and we hope that our technology will continue to grow and improve.
Are there any new major partnerships coming up?
It’s going to come down to the specific molecule or ADC we’re talking about. If we have a drug that seems to have only a few indications, we can do it ourselves. If you have a drug that you think could be used for a dozen different cancers, then you think about how you can develop it as quickly as possible and get it to as many patients as possible.
I’ve been here about 10 years and was the first employee in the oncology department. In 2015, he had one oncologist, and now he has more than 2,000 employees working in the oncology part of our business. We are much more capable today, but we know we must be open to collaborating with others.
One of the biggest criticisms of emerging technologies in oncology is that drug companies produce blockbuster products with drugs that only prolong a patient’s life by a few months. Is there any development work underway aimed at improving ADC outcomes?
This is what makes this DXd platform so unique. In the first indication (for Enhertu), we compared it to Genentech’s Kadcyle, but it extended survival by years, not months. Second-line breast cancer treatment extended progression-free survival by 28 months compared to his six months.
When considering starting an oncology franchise within a company, no other drug is more beneficial. But going forward, two things will change for him.
We’re going to move into the early stages of the disease and catch it early with powerful drugs.
The second is a move toward combination therapy with immuno-oncology treatments like Keytruda. We started late-stage as a monotherapy, but we think that could change as we move earlier and focus on the power of ADCs and immuno-oncology.
In early stages and in adjuvant or near-adjuvant situations, cure is the goal.
