Kyowa Kirin North America (KKNA) is working to address the racial disparities affecting the care and outcomes of African American patients with Cutaneous T-cell Lymphoma (CTCL).
CTCL is a rare form of blood cancer that first appears on the skin and is often mistaken for more common dermatologic conditions. CTCL can affect the skin as well as lymph nodes, blood cells and internal organs.
Approximately 30,000 people in the U.S. and Canada are affected by CTCL. On average, it takes two to seven years for a patient with CTCL to be diagnosed.
In 2018, KKNA won FDA approval for the CCR4 receptor antagonist Poteligeo (mogamulizumab-kpkc), treating adults with two CTCL subtypes: relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
To learn more about the company’s efforts related to CTCL, we spoke with Lauren Walrath, vice president of public affairs and sponsor of Kyowa Kirin North America’s Diversity Equity and Inclusion group.
In the following interview, Walrath touches on Poteligeo and Kyowa Kirin’s work to address disparities related to CTCL.
Could you provide a brief overview of Kyowa Kirin and the drug Poteligeo?
Lauren Walrath
Walrath: Kyowa Kirin is a Japan-based global specialty pharma company. We have a long history in Japan and quite a broad portfolio anchored in nephrology. We also have a number of assets in hematology, oncology, immunology and central nervous system (CNS) diseases.
Poteligeo was discovered in one of our laboratories and brought through global development. It uses a proprietary technology called Potelligent, which enhances the binding capability to cancer cells. We believe it also enhances the efficacy of the treatment against its targets.
Potelligent itself is an antibody-dependent cellular cytotoxicity (ADCC)-enhancing technology. It can be applied in a number of different therapeutic areas. Potelligent is also used in some other immunology products and by some of our licensed partners.
How did Kyowa Kirin come to focus on how CTCL affects African Americans?
Walrath: Poteligeo was a drug we took through the global MAVORIC trial. It was one of the early efforts of Kyowa Kirin to build its proprietary portfolio. As the company began to explore the development program and design the studies done in the U.S., the company consulted with several key opinion leaders (KOLs), providers and advocacy organizations. Those voices were critical to raising the issue of African American patients as essential to developing this asset. CTCL does have a disproportionate incidence among African Americans. Kyowa Kirin wanted to be sure that the clinical trials would intentionally try to enroll sufficient numbers of African American patients.
These advocacy partners and these KOLs are good advocates for including a representative patient population in the clinical program. One goal was to get appropriate data on what was then an investigative drug for the FDA to evaluate. The other goal was to generate data that physicians could rely on as they make treatment decisions.
We must credit the investigators we worked with to bring that issue forward. We worked very collaboratively with them and advocacy organizations all through that development process. We wanted to ensure that when we were ready to submit the drug application to the FDA for review, that we were confident that we had the right data for them to evaluate.
We had good success in the clinical program.
How has Kyowa Kirin worked to raise awareness about CTCL?
Walrath: In 2019, Kyowa Kirin took part in the annual American Society of Hematology (ASH) meeting. There was some data from the MAVORIC trial presented at the event that was specific to African Americans.
We began looking a little bit more at these issues and talking again to our partners such as the Cutaneous Lymphoma Foundation (CLS) advocacy organization.
Through those conversations, we understood that there were particular issues related to the lack of awareness and that CTCL patients struggled to get the care they need and the right diagnosis.
We joined forces early on, asking what we could do about this. We know there was a problem. We worked together to find ways to draw some attention to this issue and try to help patients who are truly in need.
We launched social media campaigns and communication efforts to draw attention to the disparities and the incidence of CTCL in the Black patient population.
We had a great collaboration that started with the Cutaneous Lymphoma Foundation and a couple of other advocacy organizations.
After the first wave of the efforts, we then considered what else we could do to encourage action and positive change.
So, the next effort that we started was a grant-giving program. As a business, we decided to dedicate certain funds. It was about $150,000 in the first round of grant giving. Then, we did a follow-on grant-giving program in the second year with another $100,000.
We used all our channels to announce that we wanted these funds to go to important projects to address the disparities for Black patients living with CTCL. That could be in various ways, including research and educational programs.
We wanted to say that we had these grants and were ready to disperse those funds if we received proposals from the community about what they would like to see.
We had an amazing response. We had some of the leading health institutions across the country — the Mayo Clinic, Emory, UPenn and Johns Hopkins — submitting grant proposals for new research, new translational research projects and epidemiological studies.
We’ve been thrilled to give out some funds to people looking at if some of this disparity is involved in CTCL.
We’ve also given out grants to some health institutions doing educational programming and outreach into local African American communities in South Carolina.
We’ve given some grants to patient advocacy organizations that have done webinars targeting Black patients helping them understand if they’re suffering and how to advocate for their own care. We worked with another advocacy organization doing some patient research to understand from the patient perspective if there are other barriers preventing them from getting the care they need. So we’ve funded about eight or nine different projects over about two and a half years. And we have a great commitment from our organization to continue to do that going forward.
We’re activating more efforts to address the change that’s needed.
This year, we thought about what else we can do again to continue to drive attention to the inequities facing Black patients living with CTCL.
I want to shout out to our advocacy partner, the Cutaneous Lymphoma Foundation. They are one of the only advocacy groups dedicated to this rare form of lymphoma.
They have done a wonderful job highlighting the need among this patient population. In addition, they have been great in helping connect us to important influencers willing to join this cause and share this mission.
We had a roundtable event in June during Black Family Cancer Awareness Week. And we were hoping that that timing would extend some publicity around the event and draw in more Black community interest.
We were delighted with the response that we had at the time. It was a virtual roundtable. The conversation was incredible. We were joined at that meeting by the advocacy organization’s CEO, Susan Thornton. Also, one of the investigators from the MAVORIC program continued to do clinical research in CTCL. We were also joined by a healthcare worker from the UPenn system and a woman who’s a leader within a Black nursing association. And then we had a Black woman living with CTCL who anchored this whole conversation with her story. You hear so many of the challenges facing these patients, but also so much opportunity for where we can do better.