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BRCA mutations can lead to prostate and other cancers, and men are as likely as women to inherit them. Yet male awareness is lagging.

Where Are the Men? BRCA Mutations and Male Awareness

In March 2025, the FDA approved neoadjuvant treatment with Imfinzi (durvalumab) plus gemcitabine and cisplatin, followed by single-agent, adjuvant Imfinzi following radical cystectomy in muscle invasive bladder cancer, according to a news release from the United States Food and Drug Administration (FDA).

Notably, the efficacy of the now-FDA-approved approach was evaluated in the randomized, open-label, multicenter, 

. In the study, the investigative combination demonstrated a statistically significant improvement in event-free survival and overall survival for patients with muscle invasive bladder cancer who were candidates for radical cystectomy (surgery to remove the urinary bladder).

In an interview with CURE, Dr. Matthew Galsky sat down to discuss the significance 

 and key takeaways for patients within this population.

“The most important takeaway [message] is that there has been a slow but steady improvement in our ability to treat muscle-invasive bladder cancer,” Galsky explained in the interview. “I think we are at a tipping point in the next few years, where the convergence of better therapies and better technologies — specifically, our ability to measure small amounts of cancer with increased precision using better testing — will all come together and potentially completely change the way we treat bladder cancer moving forward.”

Galsky is professor of Medicine (Hematology and Medical Oncology), director of Genitourinary Medical Oncology, co-director of the Center of Excellence for Bladder Cancer, and associate director for Translational Research, all located at The Tisch Cancer Institute, the Mount Sinai Health System, in New York, New York.

CURE: To begin, what makes this approval significant for patients and providers managing muscle-invasive bladder cancer?

: A standard treatment for muscle-invasive bladder cancer is the surgical removal of the bladder. We know that after the bladder is removed, a subset of individuals will experience the cancer reappearing elsewhere in the body, developing metastatic recurrence, typically months to years later.

For decades, doctors attempted to combine chemotherapy with surgery to eradicate any microscopic cancer cells that might be present, aiming to reduce the risk of metastatic recurrence. When chemotherapy is administered before surgery, it's called neoadjuvant therapy. This concept of giving chemotherapy prior to surgery to treat potential microscopic spread of cancer is used in various solid tumors. When chemotherapy is given after surgery, it's known as adjuvant therapy.

For decades, the only neoadjuvant therapy proved beneficial in muscle-invasive bladder cancer was a combination of chemotherapy drugs, including cisplatin. This truly represented the standard treatment approach for many years because nothing had been shown to be superior.

Finally, after several decades, the NIAGARA trial demonstrated that integrating immunotherapy in the pre-surgical and post-surgical periods decreases the risk of metastatic disease development and improves longevity for patients.

The NIAGARA trial demonstrated a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death. How do these results compare with historical outcomes using neoadjuvant chemotherapy alone?

The historical outcomes for patients with muscle-invasive bladder cancer treated with chemotherapy followed by surgery are really mirrored by the control arm of this study, as that was the control arm. Now, patients in this study fared slightly better than what we typically observe historically, likely because our treatment and supportive care have evolved.

However, we know that beyond that standard of care, the addition of immune checkpoint blockade, or [Imfinzi (durvalumab)] — both in the pre-surgical and post-surgical periods — improves our ability to prevent cancer recurrence and allows patients to live longer, even exceeding what we consider the contemporary and historical standard treatment.

What can patients expect during treatment with this combination of immunotherapy and chemotherapy — both in terms of the timeline and potential side effects?

Immune checkpoint blockade involves drugs that we call PD-1 or PDL-1 inhibitors, and Imfinzi is a PDL-1 inhibitor. These drugs have been used alone in various indications and also combined with chemotherapy for a variety of different indications across various solid tumors. So, oncologists are quite accustomed to administering these combinations at this point.

Our extensive experience thus far indicates that when you give immunotherapy with chemotherapy, it does not seem to worsen the side effects of the chemotherapy, nor does the chemotherapy seem to worsen the side effects of the immunotherapy. That said, when you administer two classes of drugs simultaneously, there's a higher overall risk for side effects because you have the potential side effects of each component, but they don't amplify each other.

Regarding side effects, those that can occur with cisplatin-based chemotherapy, in particular, are the ones many people associate with chemotherapy. These can include fatigue, nausea, vomiting, hair loss, an impact on kidney function and neuropathy, such as numbness and tingling in the fingers and toes. Fortunately, many of these side effects are transient and reversible with chemotherapy. Immune checkpoint blockade, or immunotherapy, has a very different side effect profile; many patients experience few to no side effects with it. However, a subset of patients will develop side effects that we refer to as immune-related [side effects].

These involve inflammation of different parts of the body and really mimic what we think of as autoimmune diseases, except usually, when these side effects occur, they affect one organ in an individual rather than multiple organs. For example, one individual might develop inflammation of the skin, called dermatitis, which manifests as a rash or itching. Another person might get inflammation of the bowel, called colitis, which manifests as diarrhea. When these side effects occur, if they're mild, immunotherapy is held. If they're more severe, they are typically treated with steroid medication.

When we give chemotherapy with immunotherapy prior to surgery, in the neoadjuvant setting, it's administered in three-week cycles. During each three-week cycle, treatment is given twice, once in the first week and once in the second week. These three-week cycles are repeated four times, and then surgery is performed. After surgery, the immunotherapy is generally given once a month to complete eight more months of treatment.

What follow-up research or real-world data are needed to further validate the role of this regimen?

There are several other trials testing a similar concept: should we integrate immune checkpoint blockade with cisplatin-based chemotherapy in the perioperative setting, meaning both before and after surgery?

The results of these trials collectively will, of course, enhance our understanding of the full context regarding what is being achieved with these regimens. However, as a standalone trial, NIAGARA led to FDA approval of this regimen and is now an accepted standard of care for use in patients with muscle-invasive bladder cancer.

Transcript has been edited for clarity and conciseness.

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

The FDA approved a neoadjuvant treatment regimen combining Imfinzi (durvalumab) with gemcitabine and cisplatin, followed by adjuvant Imfinzi, for muscle-invasive bladder cancer. This approval is based on the NIAGARA trial, which showed significant improvements in event-free and overall survival. The integration of immunotherapy in pre- and post-surgical periods reduces metastatic disease risk and enhances patient longevity. The treatment involves immune checkpoint blockade, with manageable side effects. Ongoing trials will further elucidate the regimen's efficacy, but it is now a standard of care.

Dr. Matthew Galsky discusses the FDA approval of Imfinzi and chemo before and after surgery for muscle-invasive bladder cancer, based on the NIAGARA trial.

Tumor

Imfinzi Combination Shows Efficacy in Bladder Cancer Treatment

Imdelltra (tarlatamab-dlle) has shown statistically significant and clinically meaningful improvement in overall survival compared to local standard-of-care chemotherapy among patients with small cell lung cancer (SCLC) whose disease has progressed on or after a single line of platinum-based chemotherapy, it has been announced.

Amgen announced the development that Imdelltra had met its primary endpoint at a planned interim analysis of the global phase 3 DeLLphi-304 clinical trial in a news release.

“Small cell lung cancer is one of the most aggressive malignancies, with a high unmet need for more effective therapies,” said Dr. Jay Bradner, executive vice president, Research and Development, at Amgen. “The topline results from DeLLphi-304 demonstrate overwhelming clinical benefit for people living with this devastating disease and affirm Imdelltra as standard of care.”

A type of immunotherapy drug known as a bispecific T-cell engager, or BiTE, Imdelltra works by bringing healthy T cells, part of the body’s immune system, and lung cancer cells closer together so that the T cells can more effectively kill the lung cancer cells, as the National Cancer Institute explained on its website. It does so by binding to the protein CD3 on healthy T cells and the protein DLL3 on small cell lung cancer cells.

“It essentially forces an interaction between the tumor and the T cells that are otherwise repelling or ignoring one another,” says Dr. Carl Gay of the Department of Thoracic/Head and Neck Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston 

. “In doing so, the T cells finally gain access to the tumor, and seemingly recognize they’ve been sleeping on the job, and go about their expected role of attacking the tumor and eliminating at least a portion, if not, in some cases, nearly all of the tumor in some of the patients that have received this therapy.”

 from the U.S. Food and Drug Administration in May 2024 for patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy was based on phase 2 results from the 

The FDA reported at the time that the most common side effects, experienced by more than 20% of patients, were cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.

The safety profile of Imdelltra, Amgen noted in the recent press release, was consistent with the drug’s known safety profile. Detailed data from DeLLphi-304, the company stated, will be presented at an upcoming medical congress.

With 509 patients enrolled, the currently active DeLLphi-304 clinical trial is being held at 223 locations around the world, according to its listing on clinicaltrials.gov. The trial, according to the listing, is estimated to be completed on July 31, 2027.

Small cell lung cancer, Amgen detailed in the news release, has a 5% to 10% five-year relative survival rate across all stages combined, and comprises approximately 15% of the more than 2.4 million patients who receive a diagnosis of lung cancer worldwide annually. And, according to the news release, despite initial high response rates to first-line platinum-based chemotherapy, most patients relapse within months and require further treatment.

Imdelltra (tarlatamab-dlle) has demonstrated significant improvement in overall survival for small cell lung cancer (SCLC) patients who progressed after platinum-based chemotherapy. This bispecific T-cell engager (BiTE) immunotherapy binds to CD3 on T cells and DLL3 on cancer cells, enhancing T cell-mediated tumor destruction. The phase 3 DeLLphi-304 trial confirmed its efficacy, leading to accelerated FDA approval. Common side effects include cytokine release syndrome and fatigue. The trial, involving 509 patients across 223 global sites, is expected to conclude in 2027.

Imdelltra is associated with improvement in overall survival compared to local standard-of-care chemotherapy among patients with small cell lung cancer.

Imdelltra May Improve Survival in Small Cell Lung Cancer

Although testicular cancer is a rare, the disease makes up the most common malignancy in men aged 15 to 44, according to the Testicular Cancer Awareness Foundation, and is often found through early detection prompted by noticeable signs such as lumps, swelling or tenderness.

April serves as Testicular Cancer Awareness Month, and according to Dr. Benjamin Garmezy, although testicular cancer is daunting, it remains highly curable, with cure rates exceeding 90%, and ongoing research continuing to improve the already high numbers of cure.

“Testicular cancer is scary. Cancer is scary. Cancer is a charged term. However, this is one that's highly curable. We say every patient diagnosed with this disease has a chance of cure, and a highly likely chance of cure,” Garmezy, a medical oncologist at SCRI Oncology Partners and the assistant director of Genitourinary (GU) Research at Sarah Cannon Research Institute in Nashville, Tennessee, emphasized.

In an exclusive interview with CURE, Garmezy delved into the topic of Testicular Cancer Awareness Month, highlighting topics like warning signs and symptoms of the disease, as well as the most common treatment options and factors that make someone more likely to develop testicular cancer.

Notably, Garmezy also serves as the co-chair of the GU Research Executive Committee at Sarah Cannon Research Institute.

CURE: What are the early warning signs and symptoms of testicular cancer that patients should be aware of?

: Testicular cancer is actually something that is often caught pretty early because the early warning signs are so obvious. Generally, a young man will feel a mass, bump, tenderness, or swelling — something like that. Testicular cancer is the most common malignancy in young men, typically between the ages of 15 to 35, but it is still quite a rare disease.

Generally, if you feel something, please go to a doctor, and you'll get it identified via, generally, an ultrasound. An ultrasound is a non-invasive imaging test that will look into the testicle and see if it's a concerning mass or not.

What are the most common treatment options for testicular cancer, and how do they impact long-term health?

The most common treatment options depend on the stage of the cancer diagnosis. As I said, most men will catch [their] disease early, and generally, what we call an orchiectomy, or surgical removal of one (not both) of the testicles, is enough to cure that patient. Then, we can just monitor them and hope nothing ever comes back. Oftentimes, the cancer does not return, and that's all that's needed.

However, some patients present with more aggressive disease at the time of diagnosis, whether that's disease that has spread to the lymph nodes (which is very common) or the lungs. These patients may need chemotherapy, radiation or further surgery, which is a dissection of the lymph nodes.

Selecting the appropriate treatment between surgery, radiation and chemotherapy is based on the pathology at the time of surgery, as well as what some of the lab values are telling us about your potential risk. This involves looking at what we call tumor markers in the blood. There are three blood values we follow: LDH, AFP and beta-HCG. We're going to use all that information, and sometimes we'll recommend chemotherapy.

Oftentimes, we don't; oftentimes, we just recommend surveillance with a schedule of scans that become wider and wider intervals as we progress, until we can eventually transition you out of an oncology clinic and have you follow up with just a primary care physician.

Are there specific risk factors that make someone more likely to develop testicular cancer?

Yes, there are a few identifiable risk factors. One of the most important, and perhaps unnoticed, risk factors is undescended testicles. This is not uncommon in young boys and toddlers. Sometimes the testicle is surgically corrected, and [sometimes it descends on its own]. However, having a history of undescended testicles is a risk factor.

For men with this history, we recommend monthly self-exams. This involves using two fingers to gently feel around, making sure the size of the testicles isn't changing and checking for any new lumps, bumps, tenderness or swellings that might indicate the need for a testicular ultrasound or a follow-up with a urologist for diagnosis to ensure it's not a malignancy. I will say that often it is not cancer. Swellings of veins and tubes in that area are more common causes of those sensations than cancer. So, don't panic if you feel something, but of course, we will want you to get it evaluated.

Undescended testicles, or what we call cryptorchidism, is one of those potential causes. Other risk factors are more nuanced, such as a family history of testicular cancer. Obviously, we're going to be more attentive to this for a patient whose parents or another family member had testicular cancer. There are certain genetic syndromes, like Klinefelter syndrome, that can be associated with testicular cancer.

However, generally, this is a disease that just happens sporadically, and one that just pops up due to what we might call bad luck.

For patients in remission, what follow-up care is needed to monitor for recurrence, and how can they maintain their overall health after treatment?

Let’s say you're cured by either surgery or chemotherapy, or maybe both. That's great news. Chances are the cancer is not going to come back. However, there's always that risk, and if it does recur, know that there are still curative options available to you, even if that cancer comes back, which is what's unique about testicular cancer — it's a highly curable disease.

Surveillance is based on your risk features. How high were those tumor markers in the blood that we talked about earlier? What was the actual spread of the disease that led to more aggressive therapy? Or was there no need for more aggressive therapy? Then you'll be followed on at least a five-year plan. Sometimes that means checking in with your physician every two months if you have high-risk features based on labs and exams. Sometimes that spaces out to every three, four or six months.

By the time you move out to year three, year four, year five, you're starting to have fewer and fewer visits with that oncologist, and you start to space out those visits, even potentially annually. So, it gets better; the highest risk of recurrence is in those first two years. But there are other things that need to be discussed at those visits. It's not just, "Is the cancer back? Yes or no," because it's often not. It's how do we continue to heal and take care of someone who has potentially had chemotherapy in the past?

So, one, we're thinking about looking at their cardiac risk factors, making sure their overall health is OK, making sure their wellness is OK, making sure other labs that maybe young men don't often get checked by their primary care doctors — well, maybe we can check some of those health labs at those visits while we have them in our oncology clinics. So, those are things to think about. And the other thing is fertility. If you had chemotherapy, hopefully, you did sperm banking prior to the chemotherapy. That's the gold standard in maintaining your fertility. A few men may still have their fertility after chemo, but we do suggest you do that upfront.

Now, if you had surgery and not chemotherapy, so you have one remaining healthy testicle, oftentimes you will remain fertile. Some providers still recommend fertility preservation prior to surgery, but not everyone does. But then you're also going to want to check for testosterone levels and just make sure that the hormonal balance in that patient is still in check, or if any tweaks need to be made.

What message would you like to impart to patients during Testicular Cancer Awareness Month to help raise awareness and encourage early detection?

Testicular cancer is scary. Cancer is scary. Cancer is a charged term. However, this is one that's highly curable. We say every patient diagnosed with this disease has a chance of cure, and a highly likely chance of cure. Over 90% of these men are going to get cured. What I tell my patients is this is hopefully just going to be a bad dream in your life's rearview mirror, and we're going to get you through it. But even if that frontline chemo doesn't work, there are other options. We can do transplant. We can do higher doses of chemotherapy and still cure patients with those salvage options.

Sarah Cannon Research Institute — where I work — has a whole host of clinical trials available for patients with novel cellular therapies, where we're genetically engineering white blood cells to go into a patient and try to directly attack the tumor, or we have a molecule that will grab onto your own immune cells and bring them into the tumor, called a T-cell engager. We have all sorts of really cool technology as well that can really help, I think, extend life and perhaps achieve more cures in patients with testicular cancer. So, that's the big picture. Understand that this is scary, but also understand that there's a lot of help out there.

Another thing to consider is, how do we catch it early so that we don't have to go through all that? That's the other big goal, and I think that involves, if you're at higher risk, definitely doing monthly self-exams in the shower, in the privacy of your own room, whatever it may be. Feel around the testicle. It's OK if one is a little bit larger than the other; that's normal. It's OK if one is a little bit more descended than the other; again, that's normal. You're looking for changes. You're looking for masses, lumps, bumps, something that doesn't feel right.

Now, you're going to have a little swelling at the top, or somewhere near the top of your testicle on the outside, because you have tubes that connect into the testicle, because the testicle has a biological function — men have them for a reason. But that's normal; you're looking at changes. Remember, if you find swelling, it's probably not cancer, but you should get it evaluated.

The thing is, don't be afraid. Go to a urologist or a primary care doctor. Get an ultrasound if you need one. Find out if you have a cancer that's easily removable before it spreads, or if this is something else, like a hydrocele or a varicocele, some kind of vascular benign swelling of those blood vessels that feed that testicle. So, don't panic, but actually do the exams.

The question is, should everyone be doing self-exams? I think that's a question we get a lot, and the answer is, we don't really know. Now, the United States Preventive Services Task Force says that's not necessary. The reason for that is, whenever they make a recommendation on screening, they consider whether it increases or decreases cure rates. In this case, we're going to cure almost everyone, so it doesn't really check those boxes. However, some oncology guidelines and societies in America and Europe suggest anyone with those risk factors we talked about earlier maybe do monthly self-exams.

To me, what do I tell people who ask me? I say: why not just do them? It takes a minute or two of your time once a month in the privacy of your own home; it doesn't take a lot of work. In the shower, you're washing yourself anyway, so it's just a good time to check, make sure everything feels right, and then ask for help if it doesn't.

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

Testicular cancer, though rare, is the most common malignancy in men aged 15 to 44. It is highly curable, with cure rates exceeding 90%. Early detection is often prompted by noticeable signs such as lumps or swelling. Treatment typically involves orchiectomy, with chemotherapy or radiation for more aggressive cases. Risk factors include undescended testicles and family history. Post-treatment surveillance is crucial, focusing on recurrence risk and overall health. Monthly self-exams are recommended for high-risk individuals to facilitate early detection and improve outcomes.

Testicular cancer is rare but highly curable, especially with early detection; treatment varies by stage, and follow-up care supports long-term health.

Knowing the Signs to Detect and Treat Testicular Cancer Early

The U.S. Food and Drug Administration has approved Jobevne (bevacizumab-nwgd), a biosimilar to Avastin (bevacizumab) for intravenous use in cancer types including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube or primary peritoneal cancer.

The approval — announced in a news release from Biocon Biologics Ltd., a subsidiary of Biocon Ltd. — is indicated for cancers including metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment and metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

Jobevne is also indicated for unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel chemotherapy as a first-line treatment as well as in recurrent glioblastoma in adults; metastatic renal cell carcinoma, in combination with interferon alfa and persistent, recurrent, or metastatic advanced cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.

Additionally, it is indicated for epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by Jobevne as a single agent for stage 3 or 4 disease following initial surgical resection; with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens and in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for platinum-sensitive recurrent disease.

The news release further notes that Jobevne is not indicated for the adjuvant, or postsurgical, treatment of colon cancer.

Jobevne, according to the news release, is a recombinant humanized monoclonal antibody, a vascular endothelial growth factor (VEGF) inhibitor designed to bind with VEGF and block the interaction with its receptors in order to prevent angiogenesis, or the formation of new blood vessels, thereby restricting blood supply to a tumor.

The FDA has approved Jobevne (bevacizumab-nwgd), a biosimilar to Avastin, for intravenous use in various cancers, including colorectal, non-small cell lung, glioblastoma, renal cell carcinoma, cervical, and ovarian cancers. Jobevne is a VEGF inhibitor that prevents angiogenesis, restricting blood supply to tumors. The approval was based on comprehensive data showing no clinically meaningful differences from Avastin. Biocon Biologics Ltd. markets Jobevne in Europe and Canada as Abevmy. This approval marks Biocon's seventh U.S. biosimilar, enhancing their oncology portfolio and commitment to affordable biologics.

The FDA has approved Jobevne, a biosimilar to Avastin, for IV use in a number of cancer types.

Linda Penwarden, MN, RN, AOCN

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