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Matthew R. Zibelman, MD, is an associate professor in the Department of Hematology/Oncology, director of Genitourinary Clinical Research, and director of Clinical and Translational Research, GU Service Line at Fox Chase Cancer Center.

Matthew R. Zibelman, MD, discusses treatment options in muscle-invasive, perioperative, and metastatic bladder cancer.

Reviewing the Options for Bladder Cancer in Different Settings

Matthew R. Zibelman, MD, discusses differing opinions in muscle-invasive bladder cancer treatment he heard when moderating a Case-Based Roundtable event.

Opinions on Treatment Split for Prominent Questions in Bladder Cancer

ASH 2024 Preview for Community Oncologists: The Show and After Show

The American Society of Hematology (ASH) Annual Meeting and Exposition aims to educate oncology providers across an array of hematologic malignancies, with a focus on novel agents, drugs across the FDA pipeline, and more.

, co-hosts Kristie L. Kahl and Andrew Svonavec offer a glimpse at some of the presentations guaranteed to spark one’s curiosity, spur debate, and enhance the field even further. Some key highlights include:

 Continued advancements in CAR T-cell therapy are expected to revolutionize the treatment of hematologic malignancies.

 Bispecific antibodies, such as Epcoritamab (Epkinly), offer a novel approach to target multiple antigens on cancer cells.

 The assessment of MRD is becoming increasingly important in predicting treatment response and overall survival.

Advances in Acute Lymphoblastic Leukemia (ALL)

Blinatumomab (Blincyto) in pediatric ALL:

 The addition of blinatumomab to chemotherapy has shown promise in improving disease-free survival in high-risk pediatric ALL. This combination therapy may offer a more effective treatment option for young patients.

Acalabrutinib (Calquence) in mantle cell lymphoma (MCL):

 The FDA is set to review the approval of acalabrutinib with bendamustine or rituximab (Rituxan) for previously untreated MCL, based on data from the phase 3 ECHO trial (NCT02972840).

Asciminib (Scemblix) in chronic phase chronic myelogenous leukemia (CML-CP):

 The FDA recently granted accelerated approval to asciminib for newly diagnosed CML-CP. This tyrosine kinase inhibitor has shown favorable safety and tolerability profiles.

 isn't just about data, as the duo also offers food recommendations, tourist attractions and fun activities to partake in, as well as interesting facts about San Diego.

This is just a taste of the wealth of information and inspiration waiting at the 2024 ASH Annual Meeting. Check back for future meeting previews with 

Targeted Oncology co-hosts Kristie L. Kahl and Andrew Svonavec highlight abstracts for community oncologists to look out for at the upcoming ASH Annual Meeting in San Diego, with some additional tidbits to round out the main event.

News

The biologics license application (BLA) of the subcutaneous formulation of nivolumab (Opdivo) coformulated with human hyaluronidase (rHuPH20) has been accepted by the FDA.

Findings from the CheckMate -67T (NCT04810078) support this BLA of subcutaneous nivolumab as the trial met its coprimary pharmacokinetic end points and key secondary end point of overall response rate (ORR) vs intravenous (IV) nivolumab in clear cell renal cell carcinoma.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for December 29, 2024.

The FDA has accepted the BLA of the subcutaneous formulation of nivolumab coformulated with rHuPH20, also known as subcutaneous nivolumab, for all previously approved adult solid tumor indications of nivolumab as a monotherapy, monotherapy maintenance following completion of the combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Results from the phase 3 CheckMate -67T trial of subcutaneous nivolumab support this application. In the trial, experts sought to evaluate subcutaneous nivolumab vs its intravenous (IV) formulation.

 Here, the subcutaneous form demonstrated noninferior pharmacokinetics and efficacy, as well as consistent safety compared with the IV formulation of nivolumab among patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.

A PDUFA goal date has been set for December 29, 2024. With this, subcutaneous nivolumab shows promise to become the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in a press release.

“[Nivolumab] is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV [nivolumab] but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30- to 60-minute infusion,” Fusaro continued.

The phase 3, randomized, open-label CheckMate -67T trial is exploring subcutaneous administration of nivolumab coformulated with rHuPH20 vs IV nivolumab for the treatment of patients with advanced or metastatic ccRCC who were previously treated with systemic therapy.

In the study, 495 patients were randomly assigned to receive either subcutaneous nivolumab or IV nivolumab. Enrollment was open to patients with a histological confirmation of ccRCC, advanced RCC not amenable to curative or radiation therapy, metastatic RCC, those who received no more than 2 prior systemic therapies, those with intolerance or progression after last treatment regimen within 6 months of randomization, and those with a Karnofsky performance score ≥ 70 at screening.

Experts assessed the coprimary end points of time-averaged serum concentration over 28 days and trough serum concentration at steady-state of subcutaneous nivolumab vs IV nivolumab. A key secondary end point of the trial was ORR.

The study met its coprimary pharmacokinetic end points and key secondary end point of ORR with subcutaneous nivolumab in this patient population.

 Subcutaneous nivolumab was noninferior in regard to time-averaged nivolumab serum concentration over 28 days and steady-state trough serum concentration vs treatment with IV nivolumab. Additionally, subcutaneous nivolumab also demonstrated a noninferior ORR compared with IV nivolumab.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 6, 2024. 

2. Phase 3 Check-Mate -67T trial of subcutaneous nivolumab (nivolumab and hyaluranisade) meets co-primary end points in advanced or metastatic clear cell renal cell carcinoma. News release. Bristol Myers Squibb. October 19, 2024. Accessed May 6, 2024. 

3. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Updated October 12, 2023. Accessed May 6, 2024. 

https://www.clinicaltrials.gov/study/NCT04810078

The FDA is considering a subcutaneous nivolumab formulation for various solid tumors based on promising data from the phase 3 CheckMate -67T trial. A target action date has been set for December 29, 2024.

Clinical

FDA Accepts BLA for Subcutaneous Nivolumab Across Various Solid Tumors

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Scientists and physicians have long been aware of links between cardiovascular disease (CVD) and breast cancer. Both conditions share common lifestyle risk factors, such as smoking, obesity, physical inactivity, and poor diet. Additionally, chemotherapy for breast cancer may increase the risk of developing chemotherapy-induced heart disease, known as cardiotoxicity.

 points to a causal relationship between the two diseases.

The population-based study of more than 19,000 older (median age 73) invasive breast cancer patients found that those with advanced breast cancer at the time of diagnosis had a 10% increased chance of prevalent CVD by comparison with matched patients with early-stage breast cancer.

The study therefore suggests that patients with CVD are at increased risk of advanced breast cancer at diagnosis.

Though the new research found a correlation between CVD and advanced breast cancer, it did not establish causality, which will require further studies. Distinguishing correlation from causality is a significant challenge in biomedical research. To illustrate this, scientists often use the fire truck analogy: the presence of fire trucks at 100% of house fires (correlation) does not imply that the fire trucks caused the fires.

Still, the identification of the correlation raises an intriguing signal that a causal relationship may exist, especially in light of previous research showing that CVD may play a direct causal role in the etiology and progression of cancer. The previous studies, which demonstrated that tumor growth is accelerated in the context of heart failure, cardiac remodeling and myocardial infarction, suggest a direct causal link, perhaps due to immunosuppression.

What should be done in response to these findings

First and foremost is the need for more education and awareness.

This study is a stark reminder that CVD—not breast cancer—is the leading cause of deathamong women in the US and worldwide.

 In 2021, it accounted for one in five female deaths (310,661 women), while over 60 million US women live with heart disease. By comparison, breast cancer claimed an estimated 42,250 lives in 2024—less than a seventh of CVD deaths.

Despite these concerning statistics, only 56% of women in the U.S. identify CVD as the leading cause of death among females. Cardiac literacy is needed now more than ever. Heart attack hospitalization rates among women under 55 are increasing, while rates among men the same age have dropped.

 Women are also more likely to die from a heart attack. And they continue to be undertreated for CVD by comparison with men.

The study also underscores the importance of regular screenings for CVD, as well as for breast cancer. If, as the study shows, CVD is a risk factor for advanced breast cancer, then cardiovascular screening and treatment can not only improve CVD outcomes, but breast cancer outcomes as well.

In addition to highlighting the need for more research at the interface of heart disease and breast cancer, a field known as cardio-oncology, the study also points up the need for more gender-specific cardiology research in general. For years, CVD was thought to be a “man’s disease.”

 Concerns about women’s health were said to be limited to the parts of the female body “under the bikini.” Because CVD was thought to be a man’s disease, research participants were primarily men. Though data from trials consisting primarily of men have historically been applied to women, women aren’t just small men.

Because women have different biology and risk factors, researchers need to do a better job at including women in cardiology clinical trials – a point that is illustrated by the 

For example, women with pregnancy complications such as eclampsia, high blood pressure and gestational diabetes have a higher risk of CVD.

 Though representation of women in cardiology clinical trials is improving, women are still underrepresented. According to a 2020 report, women made up only 38.2% of participants in cardiovascular clinical trials between 2010 and 2017.

Nor should women be considered a homogeneous group. Just as data about men can’t be extrapolated to women, data on white women can’t be extrapolated to women of other racial or ethnic groups, who may have different CVD risk factors, incidences and survival rates.

 study acknowledged by its authors is that the majority of participants (86.5%) were white women. Efforts must be made to increase the diversity of subjects, including by identifying barriers to participation, such as language, and meeting subjects where they are, i.e., in the community rather than a medical center.

Lastly, the study emphasizes the need to treat women in a comprehensive and multidisciplinary manner. Patients’ conditions usually don’t fall into distinct silos labeled “cardiology” or “breast cancer,” for instance. Six in 10 Americans have at least one chronic disease and 4 in 10 have two or more chronic diseases, according to the CDC.

 And new research, including this study, is increasingly demonstrating that age-related degenerative diseases such as heart disease and cancer are interrelated, meaning that developing one may increase a patient’s odds of developing another.

The flip side of this interrelatedness is that adopting healthy habits that reduce the risk of one chronic age-related degenerative disease, such as CVD, also can potentially reduce the risk of others. An estimated 80% of CVD, for example, is preventable by altering modifiable risk factors and “knowing your numbers,” according to the World Health Organization.

 This means – if CVD is a risk factor for advanced breast cancer – that a large percentage of breast cancer is preventable too.

This study underscores the need for further research into the link between cardiovascular disease and breast cancer. Equally important is raising awareness about routine breast cancer screenings and preventive measures, while fostering a multidisciplinary approach that ensures comprehensive care.

True progress lies not just in research but in breaking down silos—so every woman receives the holistic, proactive treatment she deserves.

1. Angelov I, Haas AM, Brock E, et al. Cardiovascular Disease and Breast Cancer Stage at Diagnosis. 

. 2025;8(1):e2452890. Published 2025 Jan 2. doi:10.1001/jamanetworkopen.2024.52890

2. About women and heart disease. CDC. Updated May 15, 2024. Accessed January 28, 2024. https://www.cdc.gov/heart-disease/about/women-and-heart-disease.html

3. Breast cancer facts & stats. National Breast Cancer Foundation, Inc. Updated January 11, 2025. Accessed January 28, 2025. https://www.nationalbreastcancer.org/breast-cancer-facts/

4. The slowly evolving truth about heart disease and women. American Heart Association. February 9, 2024. Accessed January 28, 2025.

5. Heart-health screenings. American Heart Association. Accessed January 28, 2025. 

https://www.heart.org/en/health-topics/consumer-healthcare/what-is-cardiovascular-disease/heart-health-screenings

6. Heart disease risk factors in women highlight need for increased awareness, prevention. American Heart Association. February 12, 2024. Accessed January 28, 2025. 

https://newsroom.heart.org/news/heart-disease-risk-factors-in-women-highlight-need-for-increased-awareness-prevention#:~:text=DALLAS%2C%20February%2012%2C%202024%20—,new%20scientific%20statement%20fro

7. Jin X, Chandramouli C, Allocco B, Gong E, Lam CSP, Yan LL. Women's Participation in Cardiovascular Clinical Trials From 2010 to 2017. 

. 2020;141(7):540-548. doi:10.1161/CIRCULATIONAHA.119.043594

8. About chronic diseases. CDC. October 4, 2024

Accessed January 28, 2025. https://www.cdc.gov/chronic-disease/about/index.html

9. Prevention. World Heart Federation. Accessed January 28, 2025. 

For Heart Health Month, Amy Ahnert, MD, Director, Women’s Heart Program at Morristown Medical Center, Atlantic Health System, discussed the link between cardiovascular disease and breast cancer.


Matthew R. Zibelman, MD

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