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 a combined Kidney and Bladder Cancer Patient Education Event on May 9, 2020, and for the 3rd Annual NYC Prostate Cancer Summit on September 12, 2020.


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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Inaugural NYC Prostate Cancer Summit

Over 200 prostate cancer patients and loved ones from across the Tri-State Area attended our Inaugural New York City Prostate Cancer Summit last year. The education and advocacy event was a collaboration among Manhattan’s top academic medical institutions: Weill Cornell Medicine, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center and Memorial Sloan Kettering Cancer Center. Local medical experts and national advocacy leaders came together to discuss topics including immunotherapy, screening, coping with anxiety and much more.

In case you missed the Summit, check out the video recaps below, and mark your calendar for our Second Annual Summit on Saturday, September 21, 2019.

2018 in Review: Advancements and Accomplishments

From delivering exceptional care in the clinic, to presenting at scientific conferences and publishing research in high-impact medical journals, our Genitourinary (GU) Oncology Program had an exceptionally busy 2018. We continue to work diligently to develop new and more effective therapies to treat advanced prostate, bladder and kidney cancers, while educating the community about cutting-edge advancements in the field.

As we look back on 2018, we wish to share a brief update of our research and accomplishments. Here’s what our team has been up to over the past year.

New Faces
Most recently, we were proud to welcome Dr. Cora Sternberg, a global thought-leader in the GU oncology space, to our team. Dr. Sternberg will facilitate the continued growth and development of clinical and translational research programs in GU malignancies, as well as serve as Clinical Director of the Englander Institute for Precision Medicine (EIPM) to develop strategies to incorporate genomic sequencing and precision medicine within our Program and across Weill Cornell Medicine and NewYork-Presbyterian.


New Events
More than 200 prostate cancer patients and loved ones attended our inaugural New York City Prostate Cancer Summit, a multi-institutional collaboration between Weill Cornell Medicine, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center and Memorial Sloan Kettering Cancer Center. This educational and advocacy event featured presentations and panel discussions from local medical experts and national advocacy leaders, with topics including nutrition, screening, coping and anxiety, immunotherapy and much more. Our second annual Summit is slated for September 2019 during Prostate Cancer Awareness Month. Stay tuned for details.


New Research Developments

Prostate Cancer

• Based upon our prior work with fractionated dosing of our radiolabeled antibody 177Lu-J591, we performed the world’s first phase 1 dose-escalation trial of 177Lu-PSMA-617 without finding any dose-limiting toxicity (no major side effects despite higher and higher doses), presenting the initial results at the European Society for Medical Oncology (ESMO) 2018 Congress. The phase II portion of the trial is ongoing. We are also leading the first trial combining two different targeting agents (J591 and PSMA-617) designed to deliver more radiation to tumors and less to other organs.

•  Alpha particles are several thousand-fold more potent than beta-emitters such as 177 Lu. We are completing the phase 1 dose-escalation portion of the world’s first-ever clinical trial utilizing a powerful alpha particle (225Ac) directed almost exclusively at prostate cancer cells by linking it with our J591 antibody, which avoids salivary glands.

• As prostate-specific membrane antigen (PSMA) targeting enters “prime time,” the United States Department of Defense (DOD) has recognized our significant contributions to this evolving field with a grant that will allow us to research optimal patient selection for PSMA-targeted radionuclide therapy and assess the treatment’s immune effects.

• Thanks to developing technology utilizing circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA), we are able to draw information about a patient’s tumor via a simple blood test. In our findings published by the American Association for Cancer Research (AACR) Clinical Cancer Research journal, we analyzed the relationship between chemotherapy treatment and expression of androgen receptor (AR) variants in CTCs of men with metastatic prostate cancer.

• We led a phase II clinical trial through the Prostate Cancer Clinical Trials Consortium (PCCTC) and discovered that an aggressive subset of disease called neuroendocrine prostate cancer (NEPC) is driven by a gene with an associated target known as aurora kinase. Further investigation into targeting of the gene may help us to refine therapy for this difficult-to-treat patient population. Our findings were published as a cover story in Clinical Cancer Research. 

• Working with collaborators and funded by the Prostate Cancer Foundation (PCF), we have developed unique genomics sequencing methodology called PCF SELECT that allows us to identify actionable mutations in men with advanced prostate cancer.

Kidney Cancer

• The number of United States Food and Drug Administration (FDA)-approved drugs for patients with advanced kidney cancer continues to grow. Dr. Ana Molina leads our team in offering clinical trials focused on novel targeted agents, combination treatments, and risk-directed therapies for various subtypes of kidney cancer.

• Working together with the Englander Institute for Precision Medicine, we are evaluating genetic signatures from patient tumor specimens and developing organoids that can be used to test novel pathways and tailor treatment to each individual patient.

• Laboratory studies of our in vivo kidney cancer models have resulted in discoveries regarding the metabolism of the disease. Understanding the role of the mitochondria (a cell’s power generator) in kidney cancer is leading us to novel therapeutic approaches to block tumors from growing and spreading.

Bladder Cancer

• Five immune therapies are now FDA-approved for people with advanced bladder cancer. We continue research to improve upon these agents by combining them with targeted therapeutics with the potential to replace chemotherapy. Collaboration with EIPM will help us to identify tumors most likely to benefit from these treatments.

• Dr. Bishoy Faltas and his lab team are focused on understanding the role of a specific family of proteins that cause mutations (genetic errors) that may be the underlying cause of bladder cancer. This research will enable us to develop new treatments to target the newly-identified genes that drive the disease.

• Based upon Dr. Faltas’ prior high-impact Nature Genetics publication that identified the genetic mechanisms by which bladder cancers become resistant to chemotherapy and new drug targets, we are launching an innovative new clinical trial utilizing a targeted drug that inhibits bladder cancer growth, the first time this type of drug is being tested in bladder cancer.

• We are conducting clinical trials of two antibody-drug conjugates (sacituzumab govitecan and enfortumab vedotin) designed to deliver potent chemotherapy-like toxins preferentially to cancer cells. This type of therapy is anticipated to become one of the standard approaches to bladder cancer treatment.

Precision Medicine

• Using samples of patient tumors (drawn via needle biopsy), we can create small 3-D tumor representations known as organoids that mimic the way that cancer cells grow within the body and respond to treatment. Our team has worked to develop this exciting new form of precision medicine, which is especially significant for rare cancers with a lack of preclinical models available for study.

We are moving closer to our ultimate goal of curing genitourinary cancers and look forward to continued progress in the years ahead.