Breakthroughs in Cutaneous Malignancy Treatments: Exploring Innovations in ASCO 2024 Data

Pharmacy Times interviewed Heidi Finnes, PharmD, BCOP, FHOPA, director of ambulatory pharmacy services at Mayo Clinic, on the recent breakthroughs in the treatment of cutaneous malignancies, noting trials that are reshaping clinical practice and outcomes for patients. Finnes highlights that the rapid advancement of treatment for cutaneous malignancies must be met with equitable access to these therapies, whether patients are treated in larger, academic medical settings or remote locations.

Pharmacy Times: Can you discuss recent breakthroughs in the treatment of cutaneous malignancies and how they are reshaping clinical practice?

Heidi Finnes, PharmD, BCOP, FHOPA: I think the most exciting abstract coming out of ASCO 2024 was the [PICI0001] trial [NCT02731729] where patients with stage 3 macroscopic melanoma, meaning they had some in their lymph nodes, where [they] gave new adjuvant therapy nivolumab (Opdivo; Bristol-Myers Squibb), 3 milligram per kilogram, plus ipilimumab [Yervoy; Bristol-Myers Squibb] 1 milligram per kilogram times 2 cycles. What they looked at there was recurrence free survival. They looked at response rates and results were astounding. And I think that will be a new practice change as we move forward in patients who have disease after resection.

Pharmacy Times: How do you ensure seamless coordination among dermatologists, oncologists, surgeons, and other specialists in delivering comprehensive care?

Finnes: I think the key for patients is really keeping the patient at the front of mind at all times, and ensuring their goals are the goals of the team. So often in cutaneous malignancies, diagnosis occurs with the dermatologist. And so, then translating that to the oncology team. When do they fit in versus the surgeon with radiation oncology? I think we're moving now to treating the patient where the specialties rotate around the patient versus the patient going to those different areas of the clinic to meet those specialists. And so, it's really a team centered approach with the patient in mind at all times.

Pharmacy Times: What are the primary challenges currently faced in the field of treating cutaneous malignancies, and how are they being addressed?

Finnes: The largest challenge is just the amount of new data, immunotherapy, and the advancements that have been occurring over the last 10 to 15 years. The data is coming faster than the long-term survival and many drugs are approved in an early-stage setting. So, the question becomes, when you design a clinical trial, you want to compare it to what the standard of care is, but the standards of care change so quickly. Then, new drugs like lifileucel [LN-144; Lovance Biotherapeutics] that has come out, even though there's a phase 3 trial that will enroll by the end of the year. I'm not sure it's going to tell us exactly when to give lifileucel versus ipilimumab plus nivolumab as first line treatment for patients. And so, I think the good thing is the science is advancing. It's offering a lot more opportunities for a disease that wasn't responsive to chemotherapy, but now has lots of options for immunotherapy. But I think the challenge is really how do you stay ahead? And how do you apply the data to really ensure cost effectiveness in your meeting the quality of life and in treatment needs of each patient.

Pharmacy Times: How do modern treatment approaches for cutaneous malignancies impact patient quality of life during and after treatment?

Finnes: Well, as I just mentioned, we don't give chemotherapy really any longer in many cutaneous malignancies. And I think because of that, patients with melanoma, patients with other skin cancers, have much better quality of life, they don't lose their hair, they don't have nausea, vomiting. Immunotherapy does have its own toxicities in creating inflammation in the body. But with those, people are able to continue to work while they're being treated, as well as be at their kids functions and things like that. So, I think it's really improved quality of life and proved that you don't have a label as a cancer patient throughout that.

Pharmacy Times: What advancements have been made in preventing disease recurrence and improving long-term outcomes for patients treated for cutaneous malignancies?

Finnes: So, I think with melanoma and skin cancers, people are much more proactive. Obviously, using sunscreen in children early on is very, very important. But even just the advocacy campaigns of recognizing and getting something looked at, I think has resulted in more people being diagnosed earlier. But also living longer because we're more proactive in that way. We continue to personalize medications as well. Creating vaccines from patient's own tumors with mRNA, to be able to actually create longer durable responses if patients do develop things like melanoma.

Pharmacy Times: Can you highlight any promising research initiatives or clinical trials that aim to revolutionize the treatment of cutaneous malignancies?

Finnes: Lifileucel is a tumor infiltrating lymphocyte. Basically, you take the patient's tumor, you take the tumor infiltrating lymphocytes that are in it, and then you expand those in the lab. So, [the tumor infiltrating lymphocytes] goes to a good manufacturing practice, they are grown in the lab, and then they go back to the site where the patient is, and they infuse those back after giving lymphodepleting chemotherapy. Then, subsequently, they give something called aldesleukin or IL-2 to create cell expansion in the body to really increase the efficacy associated with using your immune system against the cancer. That was approved in February of this year, 2024. For patients who have exhausted their treatments, first line program death receptor inhibitors, as well as BRAF [v-raf murine sarcoma viral oncogene homolog B] and MEK [mitogen-activated protein kinase kinase] inhibitors. But there's a first line trial called TILVANCE 301[NCT04172519] that is actually accruing in North America, Europe and Australia and they expect that it will be accrued by the end of the year. That trial is looking at using lifileucel plus pembrolizumab [Keytruda; Merck & Co, Inc], which is a program death 1 receptor inhibitor as first line therapy in these patients. So again, another novel mechanism of how to treat cancer. But again, the issue is how do you compare that to other first line therapies that are out there and now approved, like ipilimumab and nivolumab. The TILVANCE 301 trial is compared just to single agent pembrolizumab. Which one would argue with new data, especially the Checkmate 67 [NCT01909453] trial is out more than 5 to 7 years now, is what it should be compared to, so we know where that is in place for first line, second line treatments from patients?

Pharmacy Times: Looking ahead, what do you see as the most significant challenges that researchers and clinicians will face in advancing treatment approaches for cutaneous malignancies?

Finnes: I think the biggest challenge with the exciting implementation of potentially mRNA vaccines made from tumor cells with the KEYNOTE-001 [NCT01295827] trial, the lifileucel, as well, coming from a patient's own tumor. I think the challenge is going to be, how do we create enough capacity for patients who may potentially need it? And, how do we ensure access is equitable to all patients, whether they're in a remote area versus at an academic medical center? I think that's the big challenge that really science, while very advanced, needs to be thinking about. How do we make this something that isn't just an opportunity if you go to a large academic medical center, like Mayo Clinic? How do you receive that wherever you are in the world?