Category: Bladder Cancer

2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU)

The 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) brought together members of the cancer care and research community to share new, innovative findings in the study, diagnosis, and treatment of GU malignancies. This year, ASCO GU was held in a hybrid format, taking place live in San Francisco from February 16-18, as well as virtually online.

A number of members of the Weill Cornell Medicine (WCM) Genitourinary (GU) Oncology Program presented or were involved with new research findings shared at the conference, as well as trial-in-progress updates for some of the clinical trials currently underway and open to accrual at Weill Cornell Medicine and NewYork-Presbyterian Hospital (NYP).

Our team’s contributions included both scientific and treatment advancements that are leading the way for more targeted therapies and improved outcomes for patients, as well as current trial-in-progress updates on ongoing studies.

Some of our the highlights include Dr. Scott Tagawa presenting on a combination treatment of PSMA-targeted therapy and hormonal therapy for certain patients with prostate cancer, Dr. Jones Nauseef presenting details on two different Weill Cornell Medicine studies involving an investigational therapy for metastatic castration-resistant prostate cancer and a collaboration genomic alterations project, and Dr. Cora Sternberg’s involvement with two clinical trials for prostate cancer and bladder cancer which had follow up results presented.

Two of our Hematology & Oncology Fellows also presented research updates from Weill Cornell Medicine studies. Dr. Joseph Thomas shared insights from demographic patient data for those treated on prostate-specific membrane antigen (PSMA)-targeted radionuclide clinical trials and Dr. Michael Sun presented on an investigational treatment combination for metastatic prostate cancer.

Additionally, Dr. David Nanus served on an expert panel for a session on clinical decision-making for prostate cancer, “Novel Guidelines for PSMA PET Staging of Disease: When to Follow and When to Not.”

Read more specifics below on our various team members’ involvement and research from the conference.

Prostate Cancer

Dr. Scott Tagawa presented exciting new research from Weill Cornell Medicine/NewYork-Presbyterian Hospital showing that a unique combination of PSMA-targeted therapy and hormonal therapy delayed metastases in a subset of patients with prostate cancer. 

A phase I/II clinical trial evaluating the investigational therapy 225Ac-J591 is underway at Weill Cornell Medicine for metastatic castration-resistant prostate cancer. Dr. Jones Nauseef explains the study aims which were presented as part of a trial-in-progress update: https://bit.ly/3XwUE02. This trial, which enrolls patients whether or not they have previously received 177Lu-PSMA, is ongoing.

Results from a phase 3 clinical trial showed improved overall survival in metastatic hormone-sensitive prostate cancer patients receiving darolutamide, androgen-deprivation therapy (ADT) and chemotherapy. Dr. Cora Sternberg shared takeaways from this research which led to the United States Food and Drug Administration (FDA) approval of this combination in August 2022: https://bit.ly/3xkfQeO

Dr. Timothy McClure explains a focal therapy prostate cancer treatment that is being evaluated in a clinical trial at Weill Cornell Medicine in combination with lower-dose radiotherapy: https://bit.ly/3E38YXi

Weill Cornell Medicine Hematology & Oncology Fellow Dr. Joseph Thomas shared details from a research registry analyzing demographic patient data for those treated on prostate-specific membrane antigen (PSMA)-targeted radionuclide clinical trials: https://bit.ly/3xsFVbD

Dr. Himanshu Nagar shared information about an ongoing phase 2 clinical trial comparing 4 weeks to 2 weeks of MRI-guided radiotherapy after prostate cancer surgery: https://bit.ly/3HZk14W. The SHORTER trial is currently open to enrollment at Weill Cornell Medicine/NewYork-Presbyterian Hospital.

Weill Cornell Medicine Hematology & Oncology Fellow Dr. Michael Sun shared preliminary results from Weill Cornell Medicine research evaluating a treatment combination of immunotherapy, anti-androgen medication, and PSMA-targeted radionuclide therapy for men with metastatic prostate cancer: https://bit.ly/3YKBxk4. This trial has entered a randomized phase and is enrolling patients.  

Dr. Ariel Marciscano breaks down Weill Cornell Medicine research studying irradiated prostate cancer tumors in an effort to analyze and understand the changes in the tumor and microenvironment after radiation treatment: https://bit.ly/40YDVWu https://bit.ly/3I0CBtj

Members of the Weill Cornell Medicine Englander Institute for Precision Medicine collaborated with the New York Genome Institute and genomic company Isabl to identify both known and unexpected genomic alterations in prostate cancer patients. Dr. Jones Nauseef shares insights: https://bit.ly/3xk21NC

A Weill Cornell clinical trial led by Dr. Himanshu Nagar was presented comparing two stereotactic body radiation therapy (SBRT) sessions to five SBRT sessions for prostate cancer: https://bit.ly/3E6erMS.

Weill Cornell Medicine Urology resident Dr. Alec Zhu discusses new Weill Cornell Medicine research he presented comparing cryoablation treatment outcomes between men with MRI-visible and MRI-invisible prostate cancer. https://bit.ly/3YQPcpG

Bladder Cancer

Dr. Cora Sternberg breaks down long-term follow-up results on a clinical trial evaluating avelumab as maintenance therapy for bladder cancer: https://bit.ly/3XvsyC8

Dr. Himanshu Nagar shares more about a clinical trial comparing immunotherapy alone to immunotherapy plus radiation therapy for bladder cancer. https://bit.ly/3E38YXi. This trial is open across the country, with patients receiving pembrolizumab with or without radiation.

Additionally, updates to three cohorts of the TROPHY-U-01 study evaluating the antibody-drug conjugate sacituzumab govitecan were presented by a team of authors including Drs. Tagawa and Sternberg at Weill Cornell Medicine. Cohort 1 of the study enrolled patients with progressive advanced urothelial carcinoma (UC) despite platinum chemotherapy and immune checkpoint inhibitors. Initial results led to an accelerated approval by the U.S. Food and Drug Administration (FDA). In an update presented at GU ASCO 2023, the research demonstrated that efficacy was maintained and no new toxicity signals emerged despite longer follow up. In Cohort 2, patients with advanced UC who were not candidates for cisplatin or carboplatin chemotherapy following immune checkpoint inhibitors received sacituzumab govitecan which demonstrated a 32% objective response rate. Cohort 3 enrolled patients with advanced UC following platinum chemotherapy, treating them with sacituzumab govitecan and pembrolizumab, leading to a 41% overall response rate. Ongoing enrollment is testing this drug in earlier lines of therapy with different combinations. Dr. Scott Tagawa spoke about the TROPHY-U-01 study, as well as other noteworthy studies from the conference, on VJ Oncology’s GU Cancer Sessions podcast. Listen here.

The Weill Cornell Medicine GU Oncology Program is dedicated to advancing genitourinary cancer research, improving clinical outcomes, and enhancing the quality of life for all those affected by these diseases. Our team of physicians and scientists continue to conduct research throughout the year aimed at enhancing the treatment possibilities and understanding of how we can best manage and tackle GU cancers.

Bladder Cancer Treatment Options

The bladder is an organ in the lower pelvis responsible for storing urine. When cells in the bladder start to grow out of control, they can form tumors leading to bladder cancer.

Urothelial cancer is the most common form of bladder cancer and impacts around 80,000 people per year. This form of bladder cancer starts in the urothelial cells that line the inside of the bladder. Urothelial cancer may also occur in other areas of the urinary lining such as the inside of the kidneys (renal pelvis) and the tubes connecting the kidneys to the bladder (ureters)

The Weill Cornell Medicine Genitourinary (GU) Oncology Program works with a wide range of GU specialists to tailor treatments for each patient depending on their disease type and if they have metastatic disease, which is when the cancer has left the bladder or other areas of the urinary system and spread to other parts of the body through the lymph nodes or bloodstream.

Here are some of the treatment options offered for bladder cancer patients.

Chemotherapy

Chemotherapy is a common treatment option for patients with bladder cancer and can be given at a number of times throughout the treatment process. Chemotherapy may be given directly into the bladder or into veins before surgery to make a tumor easier to remove, after surgery or radiation to kill remaining cancer cells, or as a main treatment option for patients with metastatic disease.

Radiation Therapy

Another type of treatment used for bladder cancer is radiation. Radiation may also be given throughout the treatment process. It can be used after surgery, as a main treatment for earlier-stage cancers that may not require or be able to receive surgery or chemotherapy, or as part of a treatment regimen for advanced or metastatic disease. Radiation is often given along with chemotherapy to help the radiation work better, which is known as chemoradiation.

Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses x-rays to kill tumor cells. This method is able to deliver radiation precisely to the tumors and may kill tumor cells with fewer doses over a shorter period compared to other types of radiation.

Immunotherapy

Immunotherapy drugs help the body’s immune system fight cancer by instructing the immune system to identify and destroy cancer cells.

There are a number of approved immunotherapy options that may be given to patients in a variety of different circumstances. Immunotherapy can be used in patients with non-muscle invasive bladder cancer though instillation in the bladder, into veins as an additional therapy after surgery, or into veins for advanced cancer.

One of the most common versions of immunotherapy are drugs called immune checkpoint inhibitors. Immune checkpoints are part of the natural body to keep the immune system from attacking normal cells (when this happens, we call it “autoimmunity”). Checkpoint inhibitors target “checkpoints”, or proteins on the immune cells, that cancer cells use to hide from the immune system. These drugs block the checkpoints allowing the body’s immune system to attack the cancer.

Surgery

Surgery is often done before or after other treatments in order to best maximize the results. A number of surgical techniques and options exist depending on the type of bladder cancer and whether or not it has spread beyond the urinary system. These range from endoscopic techniques where a tube is inserted into the urinary system to using cameras (often with the assistance of a robot) to open surgery with incisions through the skin. Sometimes the bladder needs to be removed and there are a number of techniques to either divert urine to the skin (often with a bag) or creation of a new bladder (called neobladder).

Clinical Trials

The Weill Cornell Medicine Genitourinary (GU) Oncology Program leads and participates in a number of clinical trials across a spectrum of disease areas, including bladder cancer. Our team is dedicated to evaluating new diagnostic and treatment approaches in order to develop the best options that benefit our patients. Clinical trials may be the right choice for some patients, and we encourage you to speak to your doctor about the options available to you.

Our team is currently leading a clinical trial evaluating the effects of adding radiation therapy to the immunotherapy drug atezolizumab, for the treatment of metastatic bladder cancer. The aim of this trial is to identify if the combination of radiation and immunotherapy may have the ability to boost the results of the immunotherapy drugs and may be more effective at killing tumor cells. Learn more about this trial here.

Another interesting trial has been developed based upon the laboratory work of one of our team members. For patients with bladder cancer invading the muscle layer and needing removal of the bladder (called cystectomy), the usual approach is chemotherapy followed by surgery. However, not all patients are able to safely receive the most effective chemotherapy drug called cisplatin. This trial is evaluating the use of an oral targeted drug called abemaciclib to take prior to surgery for these patients. Learn more about this trial here.

Antibody-drug conjugates are a type of targeted chemotherapy. To date, two have been approved by the U.S. Food and Drug Administration (FDA) in various situations. We currently have trials open to enrollment testing two of these antibody-drug conjugates, enfortumab and IMMU-132, either alone or in combination with other drugs.

Our team is continuously working on new research initiatives and clinical trial participation. You can find a full list of our open bladder cancer trials here.

2019 in Review: Advancements and Accomplishments

We are proud to report another year of meaningful patient connections, exciting treatment developments and continued leadership in the field of genitourinary (GU) oncology.

Check out our team’s 2019 highlights.

NEW FACESVlachostergios Panagiotis

Panagiotis “Panos” Vlachostergios, MD, PhD, has joined our team to grow GU oncology patient care and research at NewYork-Presbyterian Brooklyn Methodist Hospital. This is a significant step in our plan to bring our world-class expertise directly to patients who live in Brooklyn, minimizing their expenses and travel time to Manhattan.

NEW EVENTS

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In addition to our digital efforts to inform the patient community of the latest news and cutting-edge advancements in the GU oncology field, we also provide opportunities to learn directly from experts via free educational events. In May, Dr. Ana Molina led our first Kidney Cancer Patient Education Symposium, which allowed kidney cancer patients to connect with one another over information sessions ranging from immunotherapy treatment to anxiety management.

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Then, during Prostate Cancer Awareness Month in September, Weill Cornell Medicine and NewYork-Presbyterian Hospital teamed up with Memorial Sloan Kettering Cancer Center and Columbia University Herbert Irving Comprehensive Cancer Center to host over 300 patients, loved ones and healthcare professionals for our 2nd Annual NYC Prostate Cancer Summit. This education and advocacy event was packed with discussions about new therapies and technologies, prostate cancer genetics, post-treatment sexual health and more.

Save the Date!
Please mark your calendar for the 3rd Annual NYC Prostate Cancer Summit on September 12, 2020, and look out for a combined Kidney and Bladder Cancer Patient Education Event in 2021.

NEW RESEARCH DEVELOPMENTS

Bladder/Urothelial Cancer

• A subset of bladder cancers are driven by the FGFR gene. We led accrual of the clinical trial that resulted in U.S. Food and Drug Administration (FDA) approval of the first targeted therapy for bladder cancer, erdafitinib, which targets the FGFR gene. This research was published in the prestigious New England Journal of Medicine.

• Immunotherapy has transformed the treatment of patients with advanced bladder cancer, but, unfortunately, only a fraction of patients respond. Dr. Bishoy Faltas led a seminal publication characterizing urothelial carcinoma that originates in the “upper tract” (center of the kidney and ureter tubes). His paper deciphers why some tumors are less likely to respond to immunotherapy and explores ways to increase response rates.

• Dr. Faltas also led work that identified the genetic mechanisms by which bladder cancers become resistant to chemotherapy and new drug targets. Based on his research, we have launched a trial of an oral targeted therapy for patients who are ineligible or choose not to receive chemotherapy prior to surgery.

• We continue to lead the development of antibody-drug conjugates, which deliver potent chemotherapy preferentially to tumor cells. In this novel therapeutic approach, a monoclonal antibody binds to specific proteins found on cancer cells, allowing the attached drug to target the cancer cells without damaging the patient’s healthy cells. One of these drugs (enfortumab vedotin) was FDA-approved in December 2019, and we are studying new combinations in earlier lines of therapy. We are also leading the pivotal clinical trial designed to get one of these antibody-drug conjugates (sacituzumab govitecan aka IMMU-132) FDA-approved and made widely available to patients. Exciting trial results were highlighted at the 2019 Genitourinary Cancers Symposium and the 2019 Congress of the European Society for Medical Oncology (ESMO).

Prostate Cancer

• Our team is at the forefront of utilizing prostate-specific membrane antigen (PSMA)-targeted therapies in the treatment of prostate cancer, currently one of the most exciting research areas in the field. We anticipate that our clinical trials will lead to FDA approval of at least one drug in the near future.

• Based upon prior work with fractionated dosing of our radiolabeled antibody 177Lu-J591, we performed the world’s first dose-escalation trial of 177Lu-PSMA-617, with results presented at the 2019 ESMO Congress. Our unique dose-dense regimen was well tolerated, with nearly 82 percent of men experiencing prostate-specific antigen (PSA) decline.

• We also completed the dose-escalation portion of the first alpha emitter (225Ac-J591) trial and will soon present the early results publicly. At the end of the year, we were notified of grant funding for an exciting future trial using this approach in combination with immunotherapy.

Kidney Cancer

• As the number of FDA-approved advanced kidney cancer drugs grows, our team remains focused on developing novel drug combinations and identifying which patients should be treated with which therapies in order to achieve the best outcomes. Our goal is to improve responses and decrease resistance to treatment by providing patients with unique combination therapies and genomic-driven targeted agents.

• Dr. Ana Molina is leading an exciting study of the antibody OX40 in combination with axitinib. Clinical and non-clinical observations suggest that combining the OX40 antibody – which stimulates the immune system and may stop cancer cells from growing – with axitinib may produce superior anti-tumor activity compared to one drug alone. This approach is being tested specifically in patients whose tumors have grown despite standard immunotherapy.

Precision Medicine

A major goal of our research is precision medicine, or the tailoring of therapy to an individual patient. Under the direction of Dr. Cora Sternberg, we continue to analyze genomic signatures, or unique tumor “fingerprints,” in patient tissue and blood samples to assess for real-time treatment targets and to discover new mechanisms of resistance to current therapies. A treatment target that we identified in an aggressive subset of disease termed neuroendocrine prostate cancer (NEPC) is making its way into clinical trials. In addition, we are spearheading work to develop organoids (mini 3-D cancer models) from patient tumor biopsies in order to test novel pathways and enhance drug development.

We look forward to persistent progress in 2020 and in the years ahead.

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