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Long is the medical director of Melanoma Institute Australia (MIA), and chair of melanoma medical oncology and translational research at MIA and Royal North Shore Hospital, The University of Sydney. 

The phase 2 GIANT trial will evaluate Opdivo with or without relatlimab in IDH-wildtype newly diagnosed glioblastoma.

Clinical Trial to Evaluate Opdivo, Opdualag in Glioblastoma

The European Commission has granted marketing authorization to Rytelo (imetelstat) monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low–, low– or intermediate-risk myelodysplastic syndromes (MDS), according to a press release from Geron Corporation. Moreover, this regulatory decision has approved the agent for patients without an isolated deletion 5q cytogenetic abnormality, as well as those who are ineligible for or did not respond to erythropoietin-based therapy.

 in the European Union and is backed by data from the phase 3 IMerge clinical trial, which had significant clinical benefit in this patient population, reducing their need for red blood cell transfusions in the first 24 weeks of treatment versus placebo.

Regarding safety, the agent was described to have had manageable and short-lived side effects, including thrombocytopenia and neutropenia. These side effects occurred at grade 3 (severe) or higher in 69% and 63% of patients, respectively, and at a median duration of less than two weeks. In more than 80% of patients, the side effects were resolved to a grade less than 2 (moderate) in under four weeks.

“As the first and only treatment of its kind, Rytelo represents an important new option — significantly reducing the need for red blood cell transfusions for people living with lower-risk MDS who are battling debilitating symptoms like anemia and fatigue,” said Dr. Joseph Eid, Geron’s executive vice president of Research and Development. “This approval from the European Commission, just nine months following approval in the U.S., underscores the positive benefit for these patients demonstrated in our clinical trials and we look forward to making this innovative therapy accessible to eligible patients in Europe.”

Rytelo represents the first and only telomerase inhibitor — a compound that blocks or slows down the enzyme which cancer cells often use to keep growing — that is approved by the European Commission.

The regulatory approval applies to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein, according to the press release. Moreover, Geron plans to make Rytelo available in other European countries starting in 2026, pending approval for coverage in each country. The company is also looking into special programs that could help eligible patients access Rytelo on a case-by-case basis.

 is a type of blood cancer that often will progress (worsen) over time, leading to symptoms like anemia and fatigue. Many patients eventually require frequent red blood cell transfusions, which can impact quality of life and shorten survival. Because of these outcomes in patients, there is a need for better treatment options, especially for patients with a poor prognosis, as current therapies are limited.

Investigators aimed to address this unmet medical need with Rytelo in the phase 3 trial. The investigative agent is a targeted therapy — 

 — for adults with lower-risk myelodysplastic syndromes who have anemia requiring frequent red blood cell transfusions and have not responded to or cannot receive standard treatments. It is given as an intravenous infusion over two hours every four weeks. 

The agent works by blocking telomerase, an enzyme that helps abnormal bone marrow cells keep dividing. By inhibiting this process, Rytelo may slow disease progression. Notably, it is also the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration (FDA).

“I am thrilled that the European Commission has approved Rytelo in lower-risk MDS. The long-term and durable responses observed in the phase 3 IMerge study reinforce the practice-changing potential of telomerase inhibition as a clinically meaningful and differentiated option for the treatment of lower-risk MDS,” said Dr. Uwe Platzbecker, IMerge investigator and a co-lead author of the phase 3 results published in 

. “Physicians and patients in Europe are now one step closer to accessing a novel treatment that, in addition to having a generally manageable safety profile, has the potential to provide extended and continuous red blood cell transfusion independence.”

Platzbecker is also the chief medical officer at the University Hospital Carl Gustav Carus Dresden in Germany.

According to the press release, Rytelo can lower platelet levels, which may increase the risk of bleeding. A patient’s doctor is expected to monitor their blood counts regularly and may delay or adjust treatment if needed, though platelet transfusions may be given if necessary. Additionally, Rytelo may also lower neutrophil levels, which help fight infections. A doctor should your check a patient’s blood counts often and monitor for infections, including sepsis. If needed, medications to boost white blood cells or prevent infections may be given.

Some patients may also experience reactions during or after Rytelo treatment, such as headache or, in rare cases, high blood pressure. To help prevent this, patients can receive medications like diphenhydramine and hydrocortisone before treatment.

Serious side effects occurred in 32% of patients receiving Rytelo. These included infections like sepsis (4.2%), fractures (3.4%), heart failure (2.5%) and bleeding (2.5%). Fatal reactions were reported in 0.8% of patients, primarily due to sepsis. The most common side effects (reported in at least 10% of patients and more frequently than with placebo) included low platelets, low white blood cells, increased liver enzymes, fatigue, muscle or joint pain, prolonged blood clotting times, COVID-19 infections and headache. 

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Rytelo (imetelstat) has received marketing authorization from the European Commission for treating transfusion-dependent anemia in adults with low-risk myelodysplastic syndromes (MDS) without isolated deletion 5q. This approval, supported by phase 3 IMerge trial data, highlights Rytelo's efficacy in reducing red blood cell transfusion needs. As the first telomerase inhibitor approved in the EU, Rytelo offers a novel treatment option with manageable side effects. Geron plans to expand Rytelo's availability across Europe by 2026, pending coverage approvals in individual countries.

The European Commission has approved Rytelo treatment in transfusion-dependent anemia due to very low–, low– or intermediate-risk myelodysplastic syndrome.

Tumor

EU Approves Rytelo for Transfusion-Dependent Anemia in Low-Risk MDS

The U.S. Food and Drug Administration has approved neoadjuvant treatment with the immunotherapy agent Imfinzi (durvalumab) plus gemcitabine and cisplatin, followed by single-agent, adjuvant Imfinzi following radical cystectomy in adult patients with muscle invasive bladder cancer, the regulatory agency announced.

The efficacy of neoadjuvant Imfinzi was evaluated in 

, a randomized, open-label, multicenter investigation which enrolled 1,063 patients who were candidates for radical cystectomy (surgery to remove the urinary bladder) and had not yet received prior systemic therapy for their cancer. The trial randomized patients to receive either neoadjuvant Imfinzi with chemotherapy followed by adjuvant Imfinzi after surgery or neoadjuvant chemotherapy followed by surgery alone.

During a pre-specified interim analysis of NIAGARA, the investigative combination demonstrated a statistically significant improvement in event-free survival and overall survival. The event-free survival was not reached in the Imfinzi and chemotherapy treatment arm whereas it was 46.1 months in the chemotherapy alone arm. Looking to median overall survival, it was not reached in the investigative combination arm and was also not reached in the chemotherapy alone arm.

Notably, according to the FDA’s website, fda.gov, side effects experienced on the trial were consistent with that of prior Imfinzi and platinum-based chemotherapy experience.

For patients weighing at least 30 kilograms, according to the regulatory agency, the recommended dose of Imfinzi is 1,500 milligram every three weeks in combination with chemotherapy prior surgery. After surgery, patients are to continue receiving 1,500 milligrams of Imfinzi alone every four weeks. For those weighing less than 30 kilograms, the dose is based on body weight.

Treatment should continue until one of the following occurs: the disease progresses to a point where surgery is no longer an option, the cancer returns, side effects become too severe or the patient completes a maximum of eight cycles after surgery.

Regarding primary end points, event-free survival served as the major efficacy outcome, which was evaluated by blinded independent central review, though overall survival was an additional efficacy outcome.

What is Neoadjuvant and Adjuvant Treatment?

Neoadjuvant and adjuvant therapy administration, according to the Rocky Mountain Cancer Centers, is used alongside surgery to treat cancer. Neoadjuvant treatment is delivered prior to a surgery, like cystectomy, and aims to shrink a tumor or stop the spread of the cancer; this is done in order to make surgery less invasive and more effective. Contrarily, adjuvant therapy is utilized directly after surgery and is done so to kill off any remaining cancer cells; the goal is to reduce the chances of recurrence.

The NIAGARA study utilized the idea of both neoadjuvant and adjuvant treatment to increase the likelihood of patients surviving without progression.

“So, what's the NIAGARA study? The NIAGARA study evaluated patients in which we want to get a high cure rate. Previously, for patients that had cystectomy, the standard of care was chemotherapy, surgery and then afterwards was to watch followed by consideration of immunotherapy, but there was no overall survival,” Dr. Chandler Park explained in an exclusive interview with CURE on the topic of the study.

“Based on the [trial] update, if a patient received chemotherapy with [Imfinzi] immunotherapy, they had a much higher chance, that after surgery, they would remain cured,” he continued. “Everybody today that has stage 2 bladder cancer and received treatment before the surgery should ask their medical oncologist for chemotherapy and an immunotherapy. Then, after surgery, maybe even consider immunotherapy afterwards. That's something I would encourage.”

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The FDA has approved the use of Imfinzi (durvalumab) with gemcitabine and cisplatin as a neoadjuvant treatment, followed by adjuvant Imfinzi, for muscle invasive bladder cancer. This approval is based on the phase 3 NIAGARA trial, which showed significant improvements in event-free and overall survival with the combination therapy. The trial involved 1,063 patients undergoing radical cystectomy. The recommended dosing varies based on patient weight, and treatment continues until disease progression, severe side effects, or completion of eight post-surgery cycles.

The FDA approved neoadjuvant Imfinzi, gemcitabine and cisplatin, followed by adjuvant Imfinzi after radical cystectomy in muscle invasive bladder cancer.

FDA Approves Imfinzi Therapy in Muscle Invasive Bladder Cancer

I am not sure if it is because I added a scoop of caffeinated coffee to my two decaffeinated scoops or if I am trying to distract myself. Likely it is a combination of both. Plus, it is spring. Spring cleaning happens. As a breast cancer survivor facing a series of tests to explore an unexpected change in my body, I have never cleaned as much as I have these past few weeks.

Scanxiety, while something survivors experience, is not what has preoccupied me most. In fact, after one of the scans, I let go of some anxiety about whatever will unfold, ordinary or not, with the process of exploring what is up with this medical glitch. Bring the scans on! They will give me clarity of mind and let me (or doctors) fix anything that needs to be fixed, if something needs to be fixed, or just let what is happening go for the time being.

Life after cancer truly is a joy. To be realistic, though, it comes with some challenges to be mindful of side effects of treatment, potential side effects of treatment, potential metastases, new developments, etc. While I have gotten pretty good about taking some of the emotions of surviving cancer in stride, I am a mere mortal. As much as I try to be positive, I have my moments.

With the current situation, before I jumped into spring cleaning with the energy of a person bound and determined to leave no corner cluttered, I did what we tend to do these days. I turned to Internet searches, including exchanges with artificial intelligence, as if I could find a clue there before my scans let me know the truth. I fell deep into the “what if” water. It could be this? It could be that? It could be anything, good or bad or in between.

The second stage was to spend less time on Internet searches and more time feeling upbeat and positive. I said to myself, “Well, you have been given an extra 15 years. Imagine that! You have lived a good life.” While contemplating a worst-case scenario, which probably happens to people who have never had cancer too, I began to feel serene, as if I was getting the emotional reaction over with before knowing I needed to have one.

The third stage was to feel at peace with whatever might come, even if that meant a return to the cancer center that I had just graduated from. Knowing the cancer center from front to back, I knew I could manage anything else I would ever have to manage, if I had to. This would not be, as they say, my first rodeo. I would be an old hand at whatever came. If it came. And would it? Most probably not. Still, when we are waiting for scans to unfold and share the appropriate information, our minds can go anywhere, even there (and by “there,” I mean “the end”).

Fortunately, between scans, I have moved to my favorite stage, the one in which I clean obsessively. One day I sawed up a large branch that smashed a dog pen. The next day I figured out how to dismantle the pen, bolt by bolt, pole by pole, to cart it to the recycling bin (all by myself) the same afternoon. I looked around the house. What next? The sunroom came first. Now my study is neater than ever. I am also a little embarrassed to admit I organized a few family heirlooms to pass down.

Meanwhile, I wait for the next scan, the one that will assure me that all is well, or not, whatever comes. Knowing I am in good company with other survivors who understand makes it all easier.

Facing the uncertainty of potential cancer recurrence, a breast cancer survivor navigates the emotional landscape of "scanxiety" with a mix of proactive distraction and acceptance. While initially consumed by internet searches and "what if" scenarios, she transitions to a more positive outlook, appreciating the life she has lived. Embracing peace with whatever outcome may arise, she channels her energy into spring cleaning, finding solace in the process. The support of fellow survivors provides comfort as she awaits clarity from upcoming medical scans.

Survivors facing new medical concerns may fear the unknown, but perseverance is possible as they navigate unexpected challenges in their new normal.

Surviving Scans While Surviving Breast Cancer

In honor of Colorectal Cancer Awareness Month, Dr. Zachariah H. Foda, who is the Assistant Professor of Medicine at Johns Hopkins School of Medicine in Baltimore, joined CURE to discuss the importance of early detection and prevention of colorectal cancer.

Throughout the conversation, Foda highlighted key warning signs that should not be ignored, such as rectal bleeding, unexplained weight loss and changes in bowel habits. These symptoms, particularly when combined, significantly increase the risk of a serious condition.

As colorectal cancer diagnoses continue to rise, especially among younger populations, Foda emphasizes the need for awareness and proactive screening, even for individuals under 50. The conversation also touched on how family history and lifestyle factors, like diet and smoking, influence screening recommendations and the overall risk of developing the disease.

CURE: What are some key warning signs and symptoms of colorectal cancer that patients shouldn't ignore?

 So, when we get concerned about colorectal cancer or other serious things that might be going on for an individual, there are certain signs and symptoms we'll look at, and things to worry about or focus on are things like bleeding from their rectum or bleeding with their stool, [or] if they're having weight loss that they can't explain or is unintentional, abdominal pain as well as change in bowel habits. But the most concerning of those findings actually would be some combination of those. And so, there have been studies to show that multiple, two, three out of that list of findings, if someone has that, it really increases the risk of something concerning going on that should trigger them to go see their physician.

What may be leading to this kind of outcome in younger patients getting diagnosed earlier and earlier, in your opinion? And is there any research being done to kind of look into why this might be?

So the short answer is, we don't know. There are many theories on why this is happening. And you know, some of these theories have been explored and are currently being explored, and [there is] actually lots of research. So, there are lots of resources throughout the country and throughout the world looking at what is sometimes called early-age onset colorectal cancer, or variably also called the birth cohort effect, meaning that it's not necessarily that it's just young onset cancer that's increasing in people born in later decades. It's actually all colorectal cancer is increasing by sort of later decades.

And so, because it is something that is happening to a large amount of people, or a whole cohort of people, the most likely explanation has something to do with something in the environment, whether that's new foods or new chemicals or changes in in lifestyle that are universal. We haven't been able to narrow it down. It'll probably take years, many years, to figure this out, because while the risk is increased, it is actually still exceedingly rare that young individuals have colorectal cancer. And therefore, in order to get enough people with colorectal cancer to do any sort of significant research on it, it takes many, many years to track this. And so, we have our theories, but it will be a long time before we're able to pick one over the other.

What age should individuals start their screenings, and how do risk factors, such as family history or lifestyle, impact the screening recommendations?

American guidelines, both from the American Cancer Society as well as all of the GI [gastrointestinal] professional societies, recommend that individuals start colorectal cancer screening at the age of 45 and that is average-risk individuals. And as you had mentioned, there are individuals who are at increased risk, and individuals that we would consider to be increased risk are those who have a first degree relative or family member, a mother or father, a sibling with colorectal cancer, a first degree relative with large or many colon polyps. And for those cases, we actually start recommending colorectal cancer screening starting at the age of 40. So, five years earlier.

And in terms of other risk factors for colorectal cancer, there are some adjustable ones such as lifestyle and diet. So, we do know that diets high in red meat and processed meat are associated with an increased risk of colorectal cancer, while diets high in fiber, high in calcium, high in yogurt, seem to be associated with the decreased risk of colorectal cancer. We know that smoking increases the risk of all sorts of cancers, and we do know that alcohol can increase the risk of colorectal and other cancers. And so while we don't recommend changes in screening guidelines based on people having those environmental or lifestyle risk factors, we do recommend that people try to temper them, or can adjust those in order to decrease their risk of colorectal cancer.

Transcript has been edited for clarity and conciseness.

Colorectal cancer awareness is crucial, especially as diagnoses rise among younger populations. Key warning signs include rectal bleeding, unexplained weight loss, and changes in bowel habits. Early detection and proactive screening are vital, with guidelines recommending screenings start at age 45 for average-risk individuals and age 40 for those with a family history. Lifestyle factors, such as diet and smoking, also influence risk. Despite ongoing research, the exact reasons for increased early-age onset remain unclear, though environmental factors are suspected contributors.

Dr. Zachariah H. Foda discusses key colorectal cancer warning signs, the rise in younger diagnoses and more.

Gastrointestinal

Colorectal Cancer Awareness: Key Signs, Screening and Prevention

At the 42nd Annual Miami Breast Cancer Conference, CURE sat down with Kelly Grosklags, a Minneapolis-based clinical social worker focused on oncology psychotherapy and the founder and chief executive officer of Conversations With Kelly, an online and in-person forum dealing with mental health, grief and oncology.

Grosklags — a psychotherapist, a Philanthropic Cancer Board Member in Minneapolis and a senior advisor at Brighter Days Family Grief Center, in Eden Prairie, Minnesota — was among the presenters at this year’s Miami Breast Cancer Conference.

, who emphasized the importance of trust between patients and providers, discussed the importance of events such as the Miami Breast Cancer Conference and more.

Can you provide an overview of your discussion and what you're really hoping that the audience takes away from the presentation?

I think a lot of conversations in breast cancer can be difficult because it's a difficult diagnosis and it's a loss. When somebody is diagnosed with cancer, there is an immediate grief that takes place, meaning life will never be the way it was prior to the diagnosis. And when people are working with their providers, one of the things that can get sidetracked is if a patient, let's say, is angry, and everybody has the right to be angry if they're dealing with something difficult. And so, one of the things we're doing at our conversation today is we're talking and doing a role play of a patient who is angry and who does not want to talk to the team about palliative care or any other kind of issues, because they feel like that might be giving up.

So, the difficult conversations don't really have to get too difficult if we have them early on, if we can establish trust with our providers and have conversations that maybe up front feel a little uncomfortable. In other words, [asking the patient,] "What are your life goals? What are some of the things that you want to see happen? What kinds of information do you want? Are you someone that likes a lot of information? Do you want limited information?"

How can oncologists effectively guide patients through shared decision making while managing any expectations they may have or fears that they're bound to have?

I think it's important for providers to know that each patient, each person, is an individual. So, what worked for your 10 o'clock appointment may not work for your 1 o'clock appointment, [even if there is the] same diagnosis, same genetic makeup, same whatever it may be. So how can they help navigate? Ask, “What kind of information do you want? How often do you want to check in about this?” And get to know really what your patient wants.

I also tell patients it's really important that you can change your mind. Maybe when you're first diagnosed, you're so overwhelmed that you don't want to have these conversations, but then later on, as time goes on and you feel more grounded or comfortable in the situation, you may want to change your answer with the doctor and say, "I want a lot more information" than maybe they wanted in the beginning.

Oncologists, obviously, are a very important part of the wellness of a patient, the treatment of breast cancer or any cancer. And how can they help navigate? It's more honestly asking questions of that patient, and then if they get to a situation they're not comfortable with, maybe it's a spiritual component, and they refer to a spiritual person, or a chaplain or a social worker, or whatever that may be.

The thing is, I don't ever want anybody on the team to ever feel like they are the sole responsibility for getting this patient through this experience. And I think we put a lot of pressure on ourselves. One of the things that's in the documentary that I talked about that is going to show tomorrow, "Dying is Not Giving Up," is … about the perfect patient syndrome and how patients show up and want to be seen as doing OK and they don't want to rock the boat. There's also the perfect provider syndrome, where we as providers can get in this space of [thinking] "I have to have all the answers. I have to be the one that fixes this. I have to do that." And I don't think that's true. I think if the oncologist can bring in the team, and the team also [including] the patient, and collectively having discussions about how to get people through difficult situations, it really is the best approach. But I will say that that oncologist absolutely has to be part of the team, and the patients will feel abandoned by their providers if they're not part of those difficult conversations.

How can clinicians initiate these hard discussions in a way that respects patients' autonomy while still providing those realistic expectations of what might come?

So, it's check-ins that are often. The mistake I see by some clinicians is that they wait too long to have conversations about, again, progression, or things that might be difficult to talk about, and the conversation can happen up when you first meet the patient. You can say to a patient "This is our goal for today, some things can change. I think we should have check-ins quite often. I think every other month, or every three months when I see you, we should go down, see how things are going, look at your labs, look at your scans, whatever that may be," and then again, asking the patient, "Is this something that you would like from me? Is this something that would help you feel more comfortable?"

Now, the other thing is, we need to have buy-in from the caregivers, from the partners, from the family, from the children, whomever that may be, because these difficult conversations may only be happening with the patient in the room, but they're going to impact lots of people. So I always say, have these conversations early and have them often. And doctors might say to me, "Well, everything's looking really good right now. It's early-stage." I said, "That's the thing. We make these conversations uncomfortable. We don't have to in healthcare." We can say, again, that "There are several ways this can go. Sometimes it may look different than we thought. I want to have really good communication with you. Is this something you want me to talk to you about? Is this something you want to know?" And again, I think it's important. I think if we save conversations that are hard for the last part, it's going to be all this anticipation and difficulty, and the patients themselves are going to feel like this is out of left field, because they haven't been having these ongoing conversations, that this could possibly be a reality.

What role should oncologists and the care team play in helping patients navigate family dynamics, particularly when family members have differing choices on the treatment decisions and prognosis?

The family and the patient are one unit of care. However, the patient is our primary concern. They're the ones that, if they're competent, so to speak, and can make decisions, we really need to listen to the patient. Family dynamics are a given, every family that has more than one person in it is going to have a dynamic, and what I find under those difficult dynamics is fear and uncertainty and possibly they don't have the information that they need.

So, we sit down, and we talk with them. We ask them, "What are you scared of? What are the things that you maybe don't understand better?" And I have had situations where families say to the patient, "You can't give up. You've got to keep going. You've got to keep going. You have to keep going with treatment." And the patient is saying to me privately, "I can't do this anymore. This isn't quality of life for me, and yet, I'm feeling a lot of pressure, and I don't want to let my family down." So that's a family conference. Then the oncologist can call a team meeting with the family and sit down and have a discussion. Always pull in multi disciplines, pull in the social worker, pull in the chaplain, pull in palliative care, whomever that may be, and approach it as more of a team effect.

But I think a lot of times, rather than telling people, it's really good to ask people like, "What do you understand?" Because this is happening to them. So, they tend to know more than we give people credit for. When the family is really struggling with prognosis and treatment, that's coming from a place of love, but we then get the family extra support, because it's not the patient's job to try to navigate and manage all of this for family. They don't have the energy, and yet, many of the patients I've worked with over the years have tried to take that on, and it's been exhausting and makes them even sicker.

The discussion emphasizes the importance of trust and communication between patients and providers in oncology care. It highlights the need for early and ongoing conversations about treatment goals and expectations, tailored to individual patient preferences. Oncologists should facilitate shared decision-making by understanding each patient's unique needs and involving the care team in addressing complex family dynamics. The role of the oncologist extends beyond medical treatment, requiring collaboration with multidisciplinary teams to support patients and families emotionally and psychologically throughout the cancer journey.

CURE spoke with Kelly Grosklags of Conversations With Kelly at the Miami Breast Cancer Conference.

Georgina Long

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