Bridget Hoyt

Keytruda and Padcev improve event-free and overall survival for adults with muscle invasive bladder cancer who cannot receive cisplatin after surgery.

The U.S. Food and Drug Administration approved Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) with Padcev (enfortumab vedotin-ejfv) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.

The approval was based off trial results from the KEYNOTE-905/EV-303 study.

Median event-free survival was not reached with Keytruda, Padcev and surgery and was 15.7 months with radical cystectomy and lymph node removal alone. Median overall survival was not reached with Keytruda, Padcev and surgery and was 41.7 months with radical cystectomy and lymph node removal alone.

The overall safety of Padcev with Keytruda was similar to what has been seen in earlier studies in advanced urothelial cancer. Keytruda carries warnings for immune-related side effects, infusion reactions, complications of stem cell transplantation and risks to a developing fetus. Padcev carries warnings for skin reactions, high blood sugar, lung inflammation, nerve damage, eye problems, infusion site issues and risks to a developing fetus.

KEYNOTE-905/EV-303 was an open-label, randomized, multicenter trial in 344 patients who were candidates for radical cystectomy with pelvic lymph node removal but were unable or unwilling to receive cisplatin chemotherapy. Patients were assigned to receive either neoadjuvant Keytruda and Padcev before surgery followed by adjuvant therapy with the same drugs, or immediate surgery alone. Event-free survival was the main goal, and overall survival was also evaluated. The study showed significant improvements in both outcomes for patients treated with the drug combination compared with surgery alone.

The recommended neoadjuvant dose is Keytruda 200 milligrams (mg) intravenously (IV) every three weeks with Padcev 1.25 mg per kilogram (mg/kg) IV, up to 125 mg for patients whose weight is 100 kg or more, on days 1 and 8 for three cycles, totaling nine weeks. In the adjuvant phase, Padcev continues for six cycles with Keytruda, given as 200 mg IV every three weeks for 14 cycles or 400 mg IV every six weeks for seven cycles. The combination lasts 18 weeks, and total adjuvant therapy, including Keytruda alone, is 42 weeks. Keytruda should be given after Padcev when both are given the same day.

The FDA approved Padcev and Keytruda for patients with locally advanced or metastatic bladder cancer

 in December 2023, less than a year after granting the combination accelerated approval for patients who could not receive cisplatin-based chemotherapy.

Padcev first received accelerated approval in 2019

 for patients with locally advanced or metastatic urothelial cancer who had received a PD-1 or PD-L1 inhibitor and platinum chemotherapy in the postsurgical or metastatic setting.

It received full approval in 2021 for patients who had received a PD-1 or PD-L1 inhibitor and platinum chemotherapy or were ineligible for cisplatin and had at least one prior therapy.

How Does Padcev Work to Treat Bladder Cancer?

“[Padcev] really made an evolution, if you will, in the urothelial or bladder cancer world,” Dr. Yousef Zakharia, co-leader of the Genitourinary Oncology Program at the University of Iowa in Iowa City, 

“It is an antibody that is directed toward certain receptors on the cancer cells,” he says. “In bladder cancer more specifically, we have NECTIN4 and TROP2. Both of them have antibody-drug conjugates manufactured toward those and are specific toward those receptors. And basically, this antibody is attached to a payload, which is a very effective chemotherapy.”

Zakharia continued, “And the way it works [is that] it takes that chemotherapy, carries it directly to the cancer cells, and it gets internalized within the cancer cells. And basically, that payload or chemotherapy gets integrated within the microtubules and starts disrupting the cell growth, and that results in cell killing. In other words, it is basically carrying the cytotoxic material directly and specifically to the cancer cells with the hope to save the normal cells from the toxic side effects associated with that if they do not have that specific receptor expressed.”

“FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer.” FDA. Nov. 21, 2025.

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The FDA has approved the combination of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) as a neoadjuvant and adjuvant treatment for adults with muscle invasive bladder cancer ineligible for cisplatin. This decision was based on the KEYNOTE-905/EV-303 trial, which demonstrated significant improvements in event-free and overall survival compared to surgery alone. The safety profile of the drug combination aligns with previous studies. Padcev targets specific cancer cell receptors, delivering chemotherapy directly to cancer cells, minimizing damage to normal cells.

FDA Approves Keytruda and Padcev for Muscle Invasive Bladder Cancer

Alyson B. Moadel-Robblee, of Montefiore Einstein Comprehensive Cancer Center discusses the BOLD Program, offering support and wellness resources.

In an interview with CURE, Alyson B. Moadel-Robblee, discussed founding the Bronx Oncology Living Daily (BOLD) Program at the Montefiore Einstein Comprehensive Cancer Center to support patients with cancer and their families. Inspired by losing her mother to breast cancer, she built the program around patient needs, offering support groups, “BOLD buddies,” and wellness workshops like yoga, reiki, meditation, and creative arts.

BOLD serves diverse communities with resources in English, Spanish and other languages and supports caregivers and children. Patients explore therapies at their own pace to improve emotional and physical well-being. Robblee also recommended at-home options like art, meditation and online resources for those outside the Bronx.

Robblee also acts as deputy director for Community Outreach and Engagement at the Montefiore Einstein Comprehensive Cancer Center and is a professor in the departments of Epidemiology and Population Health, Medicine, Radiation Oncology and Psychiatry and Behavioral Sciences at Montefiore Einstein.

CURE: What inspired the creation of the BOLD Program, and how has it evolved to meet the needs of patients over the years?

 It was a personal inspiration that started BOLD. I lost my mom to breast cancer when I was 16, and she was someone who was always looking for support, understanding and belonging. I followed her in that journey, and that was many years ago. When I got my Ph.D. in psychology, I knew I wanted to work with cancer patients. I love being in the Bronx, and I wanted to give back and help other people because I knew what it was like.

I started asking patients what they wanted in their care to help them get through cancer. They said, “I want to talk to people like myself who’ve been through it. I want support groups. I want mind-body therapies.” They directed it, so it came out organically. Then a group of advocates, volunteers and survivors came together, and we put it together ourselves. I will say it takes a village. I may be the director, but I could never do it alone.

For someone who’s just been diagnosed and is feeling overwhelmed with their options, what support or wellness options could they find through BOLD?

If you’re recently diagnosed with breast cancer, first, you should know that you are not alone. There are people here who understand and have been through it. You can speak to a survivor, called a BOLD buddy, who will share their own experience and provide support, letting you know what the journey ahead may look like. We have support groups and wellness workshops, art, creative crafts, reiki, yoga, meditation and more. Patients can come and choose what they like, like a buffet, and try different options. The most important thing is that they’re not alone and that people understand.

How does your program help patients and families manage the emotional and physical tolls of a cancer diagnosis?

I have a colleague who says, when someone is diagnosed with cancer, it’s like a psychiatric emergency. I understand that — it’s a shock, and it can feel like your world has turned upside down. The most important thing is knowing that others have been through it. You’re not alone. You can talk to a therapist, a counselor or a patient advocate who has been through it, or you can join a community and crochet if you want — just so you know you’re not alone, but with people who understand.

We also have support for caregivers, family members, and kids of cancer patients. We have tutoring and a whole community because it’s scary to go through cancer, and so many things get disrupted. But we’re here to show the journey ahead and let people know we’re going to hold their hand through it all.

The Bronx is known for its diversity. How does BOLD ensure that its programs and resources are inclusive and sensitive to patients’ different backgrounds?

The Bronx is very diverse. It’s 57% Hispanic, and the rest come from all different countries, including the U.S. Everything is in English and Spanish: counseling, support groups and workshops. We also try to bring in guest speakers who speak other languages, like Albanian or Bengali, to reach those communities. We’re trying to expand more and are totally inclusive. We want people to know we’re here for them. Wherever they’re from, they’re welcome.

What role do wellness practices, such as meditation or movement, play in helping patients heal and maintain quality of life, specifically after treatment?

When it comes to quality of life and getting back to normal after cancer, it’s not one-size-fits-all. Some people want counseling. Some want mind-body therapies, like energy medicine. Our approach is, here’s the buffet. We’ve got all kinds of things you might want to do: art classes, crochet, reiki — try it out and see what fits for you. Follow your own path. We believe that people cope differently — some are very visceral or physical; some more emotional. We give them everything and let them follow their own path.

What advice would you give to any patient who wants to take a more active role in their emotional and physical well-being but isn’t sure where to start?

If you’re recently diagnosed and scared, and you feel like, “I don’t want to talk about it, I don’t want to think about it,” that’s understandable. You have to be where you are right now, but know there’s a community out there for you when you’re ready. If you’re ready, reach out. You can talk to someone like a BOLD buddy, who can say, “Listen, I know exactly what you’re feeling.” You can just go to a group and listen. You can try creative arts. Whatever you want — there’s no obligation. You can come and go as you please. It’s really there for patients to join when they like and get what they need along the way.

What should a patient with cancer understand about reiki in cancer care?

We’re doing a groundbreaking reiki study looking at the impact of preoperative reiki for women undergoing breast cancer surgery. We’re studying its effect on quality of life, physical and emotional well-being and stress hormone levels. It’s the first study to include a sham reiki condition, which is a fake reiki, versus real reiki. We’re doing it with the head of our breast center, Dr. Sheldon Feldman. Reiki is an energy-healing modality, hands-on, and it works well with many patients because it has a spiritual element. Many patients find it soothing to enter surgery knowing someone is just holding them. We’re excited about the study, and the results should be ready in about a year.

Could you give advice for someone wanting to start their own creative healing journey at home or find communities outside the Bronx?

For those outside the Bronx, you’re not alone. Many organizations offer free wellness and cancer support. You can do a lot at home — coloring books, sketching, meditating, or looking for online resources on YouTube. Reach out, look online and find what resonates with you. There’s a lot out there, and we’re also here to provide guidance if someone wants to reach out. Start your journey and know that you’ll be okay.

Transcript has been edited for clarity and conciseness.

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BOLD Program Supports Patients With Cancer at Montefiore Einstein Comprehensive Cancer Center

CURE spoke with Alexa M. Lantz of Penn State Health about radiation side effects.

What Patients With Cancer Need to Know About Radiation Side Effects

For patients with cancer who are receiving treatment with radiation therapy, keeping lines of communication open with their care team regarding potential side effects they may be experiencing is essential, as one expert told CURE in a recent interview.

“If you’re having any sort of side effect, definitely talk with your radiation oncology team to determine whether or not it’s from the radiation, and if it is from the radiation, [find out] what you can do to improve that side effect and improve your quality of life,” said Alexa M. Lantz.

Lantz is a physician assistant with Penn State Health in Pine Grove, Pennsylvania.

Side effects vary largely by radiation site. For instance, radiation for head and neck cancers are associated with a wealth of quality-of-life complications like speech or swallowing issues, depending on the radiation site, while radiation for breast cancer is associated with skin issues around the breast and shoulder as well as cardiac toxicity.

While most radiation therapy side effects go away within a few months of ending treatment, some side effects may continue after treatment ends due to the fact that it takes time for healthy cells to recover, the American Cancer Society explains.

Lantz sat down for an interview at the JADPRO Live conference, held in National Harbor, Maryland. There, Lantz delivered a talk on a team-based approach to the management of acute and late radiation side effects, with learning objectives including a description of the radiobiology of radiation therapy and its role in multidisciplinary cancer treatment, acute and long-term toxicities of radiation therapy, interventions and management strategies for such toxicities and more.

What should patients do if they believe they are experiencing side effects from radiation?

If you’re having any sort of side effect, definitely talk with your radiation oncology team to determine whether or not it’s from the radiation, and if it is from the radiation, what you can do to improve that side effect and improve your quality of life. We would not cause a side effect wherever there was not dose of radiation going. But if my patient tells me a side effect, and I can clearly see on their plan that it’s within our radiation field, then I most certainly can say yes, you can blame us and let me help you try to fix it.

“Radiation therapy side effects,” American Cancer Society; https://www.cancer.org/cancer/managing-cancer/treatment-types/radiation/effects-on-different-parts-of-body.html

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What Patients With Cancer Should Know About Radiation Side Effects

Exercise, as an expert explained to CURE, can have a significant positive impact on long-term outcomes for patients with cancer.

Following the publication of findings in 

, senior medical affairs liaison with ImpediMed and an expert in cancer rehabilitation and survivorship care, about the importance of exercise for patients as well as simple ways that they can safely start moving.

Can you explain in simple terms why exercise has such a powerful impact on long-term cancer outcomes?

The study was done with patients who had high-grade stage 2 or stage 3 colon cancer. Believe it or not, 20 years ago there was evidence suggesting that exercise could help, but what researchers really needed was a randomized controlled trial. That’s what makes this study so important — it actually divided patients into two groups. One group received standard care, which meant they were simply encouraged to be more physically active. The other group participated in a structured exercise program with instructors and classes, rather than just being handed a pamphlet.

The outcomes were impressive. Everyone expected to see some benefit, but we didn’t realize just how strong the effect would be. The benefit from exercise was comparable to giving patients an actual treatment, like chemotherapy. That’s how powerful it is — almost like a drug.

As for why exercise works this way, there are several hypotheses. One key idea involves something called myokines. Most people have heard of cytokines — especially during COVID, when we talked about cytokine storms. Cytokines are signaling molecules released in the body, and our muscles actually release a special kind called myokines.

These myokines act as messengers that travel throughout the body — to the brain, heart and other organs — helping to control inflammation and fatigue. This may be why exercise improves energy levels. It’s amazing to think that movement can trigger this kind of response almost immediately, not just over time.

If you’re feeling tired and think you should rest, that’s often the worst thing to do. Even light movement can stimulate the release of myokines that make you feel better — sometimes within minutes. That’s really the key takeaway: exercise provides both immediate and long-term benefits, and it doesn’t have to be intense — simple movement counts, too.

For patients who may not feel as physically fit or are nervous after treatment, what are some safe first steps they can take to begin exercising again?

A lot of people hear that word, “exercise,” and they think, “Oh my gosh. They want me to go to the gym and lift heavy weights, and they want me to get on a treadmill or on a stair climber. I don't like going to the gym,” or, “I don’t have the time, it’s too far away,” or “I don’t have the money.” People are scared, and they think that we’re trying to get them into something like CrossFit, and we’re not: we’re trying to get them off of the couch or out of the bed or out of the chair.

So I tell patients, start simple, and the first thing may be asking for help, whether that’s from a family member from your care team. Just be honest and say, “I really don’t know what to do.”

It can be as simple as just getting up out of a chair and seeing if you can do that 10 times in a row. That’s usually where I’d start with a patient. If you can’t, I really want you to call your care team and say, “I think I need help.” So that’s a very simple step, as is putting on walking shoes and going outside and walking, or another option if you’re living someplace where the weather may not be good, is every time you’re watching television, get up and move during the commercials. In a 30-minute TV show, you may actually get 10 minutes of exercise if you stand up and move every time.

I like to tell patients pop music is great because most songs are three minutes long — find your favorite song, put it on your phone and just get up and see if you can just do some dance that whole time. ... It can just be as simple as picking your feet up and down. Those are the first steps. When you start to do that every day, you’d be surprised. By the end of a month, most people can start to exercise or move for the required 30 minutes a day that we’d like you to get.

Exercise significantly enhances long-term outcomes for cancer patients, akin to the effects of chemotherapy. A recent study involving high-grade stage 2 or 3 colon cancer patients demonstrated that structured exercise programs yield substantial benefits. The release of myokines during physical activity helps control inflammation and fatigue, providing immediate and long-term advantages. Patients are encouraged to start with simple movements, such as standing up from a chair or walking during TV commercials, to gradually build up to 30 minutes of daily exercise, improving their overall health and well-being.

Bridget Hoyt

FDA Approves Keytruda and Padcev for Muscle Invasive Bladder Cancer

BOLD Program Supports Patients With Cancer at Montefiore Einstein Comprehensive Cancer Center

What Patients With Cancer Should Know About Radiation Side Effects

Simple Ways for Patients With Cancer to Start Exercising

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