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.

What Patients with Prostate Cancer Should Know About PSMA Imaging and Therapy

Prostate cancer begins when cells in the prostate gland start to grow out of control. These cancerous cells may remain in the prostate or metastasize and spread to other parts of the body such as the bones, lymph nodes, liver, or lungs. 

Prostate-specific membrane antigen (PSMA) is a protein found on the surface of prostate cancer cells. PSMA-targeting can be used to locate, identify, or treat cancerous cells in both the prostate as well as cancerous cells that have metastasized in other organs. This targeting can involve attaching a radionuclide, a particle that gives off radiation, to different molecular agents, most often monoclonal antibodies or small molecule targeting agents (also known as peptides, ligands, or inhibitors). This combination attaches to the PSMA receptors located in the cancer cells. 

PSMA positron emission tomography (PET) scans are an imaging technique approved by the U.S. Food and Drug Administration (FDA). PSMA PET is able to precisely locate prostate cancer cells using a radioactive imaging agent that binds to prostate cancer cells to help localize them. This drug is injected into the body and attaches itself to PSMA proteins expressed by prostate cancer patients. The PET scan is then able to detect and pinpoint the prostate cancer tumors.

Weill Cornell Medicine was one of the first centers in the United States offering this technology for patients. PSMA PET is able to identify whether the cancer has spread beyond the prostate gland with higher accuracy than other imaging methods. 

The team at the Weill Cornell Medicine Genitourinary (GU) Oncology Program has been a pioneer for PSMA-targeted therapies for many years. PSMA-targeted radionuclide therapies lead the combination of radionuclide and molecular agents directly to the PSMA cell receptors. The ability for the targeting agents and the PSMA receptors to join together provides this therapy the ability to precisely target prostate cancer cells.  

In March 2022, the FDA approved 177Lu-PSMA-617 (also known as Lu 177 vipivotide tetraxetan or Pluvicto) for the treatment of patients with metastatic castration-resistant prostate cancer. Dr. Scott Tagawa, director of the Weill Cornell Medicine Genitourinary (GU) Oncology Program, was a member of the steering committee for the trial evaluating this treatment that led to the approval. 

“The first availability of tumor-targeted radionuclide therapy on a commercial basis will allow patients with more limited resources that might not have been able to travel for a clinical trial or overseas to receive the benefit of this treatment. The first successful phase 3 trial allows us in research to optimize the treatment, study it in earlier disease states, and explore combinations with other therapies with scientific merit. Even after this approval, I encourage clinical trial participation and/or referrals.”

Scott Tagawa, MD, MS

Weill Cornell Medicine will be one of the first centers able to offer this therapy to patients immediately for both our existing patients and those who may be referred to us if their local provider doesn’t immediately have access to this therapy.  

Our team continues to lead and participate in a number of clinical trials aimed at ongoing testing and research for additional PSMA-targeted imaging and treatment. We are one of few centers in the world currently able to provide treatment plans that involve both PSMA-PET imaging and multiple PSMA-targeted therapies for our patients, as well as the opportunity to participate in these types of clinical trials in order to further develop PSMA technology.  

The Weill Cornell Medicine Genitourinary (GU) Oncology Program provides top-notch care, knowledge, and expertise for our patients. We offer new patient appointments, second opinions, and ongoing care for people with genitourinary cancers, including prostate cancer. To learn more or to make an appointment with one of our physicians, please call us at 646-962-2072. If interested in a clinical trial, please email us at guonc@med.cornell.edu.