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Tumor

AU-007, combined with Opdivo and low-dose aldesleukin, has entered a phase 2 melanoma trial, with early data showing activity and manageable safety.

AU-007 Combo Dosing Begins in Melanoma Phase 2 Trial With Opdivo

KSQ-004EX is being evaluated in solid tumors including melanoma, non-small cell lung, head and neck, colorectal, pancreatic and cervical cancer.

First Patient Dosed With KSQ-004EX In Solid Tumor Clinical Trial

CURE spoke with Dr. Michael K. Wong and Dr. Diwakar Davar about the use of ctDNA for patients with melanoma, and where the field may be headed.

What Role May ctDNA Have in Melanoma Management?

I was diagnosed with stage 3 melanoma at 31, faced recurrence and now share my journey to raise awareness, stay hopeful and trust in God’s plan.

Melanoma Taught Me Faith, Gratitude and That Nothing Is Permanent

The FDA granted Breakthrough Therapy designation to IDE196 for the neoadjuvant treatment of primary uveal melanoma when enucleation has been recommended.

FDA Grants Breakthrough Therapy to IDE196 in Primary Uveal Melanoma

The advantages and disadvantages of CAR-T cell therapy should be carefully thought about for patients with melanoma.

Addressing Pros and Cons of CAR-T Cell Therapy in Melanoma

For patients with melanoma, treatment with CAR-T cell therapy may come along with pros and cons to consider.

T-cells are immune cells that recognize and destroy foreign invaders in our bodies. CAR-T cell therapy harnesses this power by removing the body's germ-fighting T cells, engineering them to attack cancer cells, and then infusing them back into the body, as explained by an expert in an interview with CURE®.

CURE® interviewed Dr. Anusha Kalbasi, an associate professor of Radiation Oncology at the Stanford School of Medicine, to gain insights into the usefulness and drawbacks of CAR-T cell therapy.

Some patients have an immune system that naturally is ready to attack the cancer, and some drugs or some other treatments may work, like TIL therapy, may work for those patients. But in patients [whose] body's own immune system isn't finding and killing the cancer, we need to come up with an alternative strategy, and CAR-T cell provides an alternative for those patients. So that's one advantage.

The other thing is CAR-T cells can potentially come in with one treatment and clear tumors and then survive in the body as kind of like security guards. So, the idea that this is a living drug that is, it's not just a drug that you give, and it gets excreted out through the kidney, but it's a drug that stays in your body forever and continues to fight on your behalf.

That's one of the benefits. But there are downsides.

You're injecting large numbers of T-cells into the body. You're genetically modifying the T-cells, so there are some risks potentially associated with that, although those risks are very low, if any, and then when the cells expand to try to fight the cancer, there's a lot of inflammation that happens potentially that can cause side effects, that can be detrimental to the patients.

But we've learned a lot from our experiences in blood cancers and how to manage these side effects. And so, we think we can make CAR-T cells safe and effective.

This transcript was edited for clarity and conciseness.

For more news on cancer updates, research and education, don’t forget to 

subscribe to CURE®’s newsletters here.

CAR-T cell therapy for melanoma involves engineering T-cells to target cancer cells, offering an alternative for patients whose immune systems do not naturally attack cancer. This therapy can potentially clear tumors with a single treatment and remain in the body as a long-term defense. However, the process involves risks such as inflammation and side effects due to the large number of genetically modified T-cells introduced. Despite these challenges, advancements in managing side effects from blood cancer treatments suggest CAR-T cells can be made safe and effective.

An expert explained how a patient’s own T cells can be extracted, manufactured and infused back into the body as a treatment option for melanoma.

TIL Therapy Uses the Body’s Own Cells to Attack Cancer Cells in Melanoma

Tumor-infiltrating lymphocyte (TIL) therapy is a promising new approach to cancer therapy that harnesses the body’s own immune system to treat diseases like melanoma, a type of skin disease, an expert said.

In February 2024, Amtagvi (lifileucel) was the first 

 to treat patients with advanced melanoma whose disease progressed on or after anti-PD-1/PD-L1 therapy and targeted therapy. With TIL therapy, T cells are extracted from a patient’s tumor, grown in a lab and then reinfused back into the patient to attack cancer cells.

As research progresses, TIL therapy may become a more accessible and effective treatment for other cancers.

CURE® spoke with Dr. Goran Micevic, assistant professor of dermatology and dermatopathology at Yale and member of the Yale Cancer Center, to learn more about TIL therapy and how the science behind it.

TIL therapy is kind of a new old therapy because the concept behind TIL therapies has been around for several decades really. It's been spearheaded at the surgery branch at the National Cancer Institute by Dr. Steven Rosenberg.

But the basic idea is that you take T cells, which are, you know, immune cells that can recognize foreign threats from the patient, you expand them outside of the patient's body and then you reinfuse them in an effort to battle cancer.

And so this is kind of a live therapy, as opposed to chemotherapies, which are chemicals and molecules, and as opposed to immune therapies, which we've kind of [been] witnessing the revolution [of], which are still molecules. So these are live cells, and they're the patient's own cells.

And it is a fairly complex therapy, and it's gone over several iterations, and usually is available only in an inpatient setting, or at least has been so far. And the reason for that is that when you infuse somebody with their own T cells, there's a lot of preparatory work that you need to do. So it's not unlike a bone marrow transplant. It's very involved really. So you have to prepare the patient and essentially immunosuppress them.

So you give them a lymphoablative therapy over a period of about a week prior to them receiving their own cells, and then when they receive the cells, you still have to receive what we call interleukin-2, high-dose interleukin-2, which is a chemical that actually activates T cells to kind of wake them up from their slumber. But you know that treatment also induces some unpleasant symptoms which are not unlike an inflammatory condition called sepsis.

Tumor-infiltrating lymphocyte (TIL) therapy represents a novel immunotherapy approach, utilizing the patient's own T cells to combat cancer, particularly advanced melanoma. In February 2024, Amtagvi (lifileucel) became the first FDA-approved TIL therapy for melanoma patients unresponsive to prior treatments. The process involves extracting T cells from tumors, expanding them in vitro, and reinfusing them into the patient. Despite its complexity and inpatient requirement, TIL therapy holds promise for broader cancer applications as research advances.

Patients with resectable stage 3 melanoma should talk about pretreatment therapy with their cancer care teams, an expert said.

Patients With Stage 3 Melanoma Should Discuss Adjuvant Therapy

Patients with resectable stage 3 melanoma should be talking with their care teams about presurgical (adjuvant) therapy, according to Dr. Georgina V. Long.

“[For] any patient who comes in with resectable stage 3 melanoma that's clinically detectable, They need to be talking to their physicians, their doctors, about neoadjuvant treatment — particularly neoadjuvant immunotherapy,” Long said during an interview at the 2024 

American Society of Clinical Oncology (ASCO) Annual Meeting

Long is the chair of melanoma medical oncology and translational research, at The University of Sydney in Australia. At the 2024 ASCO meeting, she presented long-term follow-up data from the 

. The trial analyzed Tafinlar (dabrafenib) plus Mekinist (trametinib) for this patient population, and showed that at the eight-year mark, 71% of patients on the drug duo were still alive, compared to 65% who were given a placebo.

Further, Tafinlar plus Mekinist showed no new safety concerns that were not previously reported, and there were no irreversible side effects.

“The great thing about [Tafinlar] and [Mekinist] is the toxicities are reversible,” Long said.

Tafinlar and Mekinist are targeted therapies that work by blocking certain proteins that are essential in cancer cell growth, according to the Melanoma Research Alliance. The 

drug combination was approved in April 2018

 based on earlier findings from the COMBI-AD trial.

[For] any patient who comes in with resectable stage 3 melanoma that's clinically detectable, They need to be talking to their physicians, their doctors, about neoadjuvant treatment — particularly neoadjuvant immunotherapy.

Patients with lower risk or not clinically detectable stage 3 melanoma then they need to discuss with their physicians, adjuvant treatment and that is where the discussion of the [Tafinlar] and [Mekinist] versus the other available adjuvant treatments occurred. The great thing about [Tafinlar] and [Mekinist] is the toxicities are reversible.

Conference

What advice do you have for patients and caregivers of those recently diagnosed with uveal melanoma?

Because metastatic uveal melanoma is so rare, it’s very important that patients seek a provider who’s familiar with the treatment landscape.One of the other things patients with uveal melanoma can do when they’re first diagnosed is seek out information provided by patient advocacy organizations.

Now that Kimmtrak [tebentafusp] has been approved for metastatic uveal melanoma, it has really brought to light a lot of the differences between uveal melanoma and skin melanoma, and the need for additional treatments. Specifically, there’s a huge unmet need that remains for patients who are HLA-A*02:01 negative. I’m happy to say that there are a number of ongoing clinical trials looking at new treatment options. Having an FDA-approved therapy has also brought greater awareness to this rare melanoma subtype.

Thank you for joining me to learn about uveal melanoma. We hope you found this 

Marlana M. Orloff, MD, offers advice for patients who are diagnosed with metastatic uveal melanoma.

Advice for Patients Diagnosed with Metastatic Uveal Melanoma

How is Kimmtrak administered? What can patients expect from treatment? How are adverse events managed?

Kimmtrak [tebentafusp] is a weekly IV [intravenous] infusion. Due to the risk of side effects, specifically cytokine release syndrome, the first three doses have to be given in an extended monitored setting where patients are observed for at least 16 hours. During this time, the patient’s vital signs are monitored very closely as there is a risk for low blood pressure, high fever, and low oxygen. Should these occur, patients are managed appropriately, sometimes with things like IV fluids, medication to get the fever down, and in some scenarios, if severe enough, they may require steroids.

For the majority of patients, adverse effects peak during the first three doses, and after the third dose, patients can be safely transitioned to receive their infusion as an outpatient. Most patients following those first three doses do not experience significant adverse effects. One of the more long-term side effects we see for patients who’ve been on tebentafusp for a long time can be things such as whitening of the hair, eyebrows, eyelashes, and skin, which is called vitiligo.

An expert on uveal melanoma reviews the treatment protocol for tebentafusp, which is approved for the treatment of metastatic disease.

Tebentafusp Treatment Protocol in Metastatic Uveal Melanoma

For patients who are eligible for treatment with Kimmtrak, how does this treatment work?

Kimmtrak [tebentafusp] is a newer type of immunotherapy, also called a T-cell redirector, that acts like a magnet that combines your own immune system, your T cell, and drags it over to a target on the cancer, something called gp100 [glycoprotein 100], and kind of forces them to engage, hopefully allowing the immune system to kill the cancer.

In the clinical trial, they compared Kimmtrak to investigator’s choice, which could have been pembrolizumab, dacarbazine, or ipilimumab. Kimmtrak showed a 1-year overall survival of 73% vs 59% in the comparator group. It was this improvement in overall survival that led to the FDA approval of Kimmtrak.

Due to Kimmtrak’s unique mechanism of action, one of the most common adverse effects we can see is rash. The drug can drag the immune system over to something called gp100, which is on the surface of the tumor but also on melanocytes in the skin causing the rash. One of the other adverse effects that we need to monitor patients very carefully for is something called cytokine release syndrome. This type of syndrome is really due to immune overstimulation, and we can see things such as fever, low blood pressure, and low oxygen. It’s very important that these patients are monitored, at least for the first 16 hours, for the first three doses, to ensure that this syndrome, if it does occur, is managed appropriately.

Marlana M. Orloff, MD, discusses key efficacy data and reviews adverse events seen with tebentafusp in patients with metastatic uveal melanoma.

Efficacy and Safety of Tebentafusp in the Treatment of Metastatic Uveal Melanoma

For patients with metastatic uveal melanoma, what are the treatment options?

Metastatic uveal melanoma is unique in that when patients recur, close to 90% or more recur in their liver. For this reason, when we’re talking with a patient about treatments, we can often talk to them about liver-directed or local regional therapy where we treat just the liver or systemic therapies that treat the whole body. Historically, uveal melanoma has been lumped in with skin melanoma, and the treatments that we’ve used for systemic management and systemic treatment have been skin melanoma treatments. However, we know that uveal melanoma is a very different disease than skin melanoma, and that’s why these treatments often didn’t work very well. It wasn’t until 2022 that we had our first FDA-approved therapy specific for uveal melanoma, a drug called tebentafusp, or Kimmtrak.

How do you choose the best treatment for each patient?

When a patient with metastatic uveal melanoma comes to talk about different treatment options, we look at a few different things to determine what the right next step might be. One of the first things we look at is their HLA [human leukocyte antigen] type. The drug that has been FDA approved for the treatment of metastatic uveal melanoma is restricted to patients who are HLA-A*02:01 positive. This matters because Kimmtrak acts like a magnet to drag the immune system over to the cancer cells. And the way that this drug engages with the patient’s immune system is through something called HLA. So it’s very important that a patient is the right HLA for this drug to work. For patients who are HLA-A*02:01 positive, we may choose Kimmtrak as a treatment choice. For patients who are HLA-A2 negative, we can sometimes look at those liver-directed or regional therapies or clinical trials.

When a patient’s diagnosed with metastatic uveal melanoma, it’s important that they talk to the physician about getting a blood test to determine their HLA type. Because again, knowing your HLA type and knowing if you’re HLA-A*02:01 positive may be the determining factor of whether or not Kimmtrak is a treatment option.

Dr Marlana M. Orloff provides an overview of the treatment landscape for metastatic uveal melanoma.

The Metastatic Uveal Melanoma Treatment Landscape

How does uveal melanoma typically present and how is it diagnosed?

Patients with uveal melanoma can present in a couple of different ways. Some patients have a freckle in the eye that’s followed over time. Other patients just show up for a routine eye exam and it’s found. But most patients do have some sort of visual disturbance that brings them first to the eye doctor. Oftentimes, it’s retinal detachment symptoms like flashes and floaters. Patients will first see an eye doctor, are often then referred to a retina specialist, and then ultimately an ocular oncologist, who uses ultrasound and direct visualization to diagnose the eye melanoma.

What is the typical prognosis for patients diagnosed with uveal melanoma? How is the primary tumor treated?

Once the diagnosis of uveal melanoma is made, the ocular oncologist often discusses with the patient options for treatment of the primary tumor. This could [be] plaque radiation, nucleation, removal of the eye, or external radiation. Primary treatment of the eye tumor, regardless of the method, is very effective. The risk of it coming back in the eye is actually quite low. Patients are then often referred to a medical oncologist for surveillance to make sure that the cancer doesn’t come back in other parts of the body.

Despite the very effective treatment of the primary tumor, about half of the patients—and this is all comers—can recur with the cancer most commonly in the liver at some point after the primary eye diagnosis. We think that before the eye tumor is even treated, it’s possible that some cells could have gotten out and could lead to metastasis in the future. Because we don’t have the ability to really search for those single cells floating around, we rely on information about the primary tumor like the size and genetics to try to estimate what a patient’s risk is. For patients with very large tumors, we think their risk may be a little bit higher. Patients with things like monosomy 3, 8q amplification, or something called a class 2 genetic signature may have a greater than 50% risk of the cancer returning. Depending on a patient’s risk assessed by tumor size and genetics, we then monitor patients. The higher the risk, the closer we follow them. And often following these patients involves a series of things like MRIs, CT scans, and meeting with a medical oncologist.

An expert on uveal melanoma discusses the presentation, diagnosis, and prognosis of the disease.

Diagnosis and Prognosis of Uveal Melanoma

 on metastatic uveal melanoma. I’m Dr. Marlana Orloff, an associate professor of medicine at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. I’ll be offering insights about uveal melanoma. I’ll also be discussing the only currently FDA-approved first-line treatment for patients with metastatic uveal melanoma.

What is uveal melanoma? What are the risk factors?

Uveal melanoma, sometimes called ocular melanoma or eye melanoma, is the most common eye tumor in adults, but it is a very rare subtype of melanoma, only affecting about six per million people. We don’t know what causes eye melanoma. Unlike skin melanoma, we don’t think UV [ultraviolet radiation] is the cause. However, risk factors are similar to eye melanoma in being fair skinned and having light eyes. For most patients with eye melanoma, it is a spontaneous disorder, meaning it isn’t necessarily inherited. But in about 1% to 2% of all eye melanoma, they can inherit a genetic mutation called BAP1 syndrome.

Marlana M. Orloff, MD, gives a brief overview of uveal melanoma, including its incidence and risk factors.

Melanoma

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