Don S. Dizon, MD, on Ovarian and Other Extrarenal Clear Cell Carcinomas: Update on Nivolumab and Ipilimumab

2024 ASCO Annual Meeting


Don S. Dizon, MD, of Legorreta Cancer Center at Brown University and Lifespan Cancer Institute, discusses final phase II results of the BrUOG 354 trial showing that, for patients with ovarian and other extrarenal clear cell cancers, nivolumab and ipilimumab warrant further evaluation against standard treatment, given the historically chemotherapy-resistant nature of the disease (LBA5500).


Disclaimer: This video transcript has not been proofread or edited and may contain errors.
I will be presenting BrUOG 354 which is a two-arm randomized non-comparative clinical trial that enrolled people with extrarenal clear cell carcinoma. And tested two regimens, both of them immunotherapeutic. One used nivolumab alone, and the other used nivolumab plus ipilimumab. We enrolled 46 people to this trial, 44 of whom were treated. All of these patients had a diagnosis of clear cell cancers of the gynecological tract. And that's important because clear cell cancers when you compare them to the more common serous type cancers, are associated with a worse prognosis. They do not respond as well to our standard chemotherapies, are prone to relapse more frequently. And unfortunately in the context of recurrent disease, they do not respond as well to treatment. So the prognosis is actually quite poor. This prompted this clinical trial. And it was actually based on some very preliminary data where people were seeing clinical complete responses in folks with clear cell cancers. To this point, before this trial was presented, there had been two trials of immunotherapy in ovarian cancer. One suggesting that clear cell cancer was associated with a five-fold higher response rate compared to other histologies. Although that clinical trial which was done by NRG Oncology group, only enrolled 12 people with clear cell. For that, suggestion was made. And the other was a SWOG clinical trial that enrolled 18 people with ovarian cancer and showing that the combination of nivolumab and ipilimumab was effective with some durability, again, based on a very small number of patients. So our trial which enrolled 46 people, is the largest trial in this very rare cancer population. What we can report is that both single-agent nivolumab, and nivolumab and ipilimumab have activity in clear cell cancers, and both are associated with survival outcomes although the one with combination therapy is longer. The overall response rate with single-agent nivolumab is 13%, which includes two partial responses. Median progression free survival is two months, and median overall survival in this trial was less than six months. With the combination therapy, the overall response rate was 33% with five complete responders. Median progression free survival in that arm was 17 months, and median overall survival is 24 months. And importantly for those who responded to the combination, the response was durable. And we had several patients who remain on study past two years, including up to today.

Related Videos

Multiple Myeloma

Xavier P. Leleu, MD, PhD, on Multiple Myeloma: Update on Isatuximab, Lenalidomide, Dexamethasone, and Bortezomib

Xavier P. Leleu, MD, PhD, of France’s Université de Poitiers and Centre Hospitalier Universitaire de Poitiers, discusses phase III findings showing that isatuximab in combination with bortezomib, lenalidomide, and dexamethasone deepened responses and increased the rate of measurable residual disease negativity vs isatuximab with lenalidomide and dexamethasone in patients with newly diagnosed transplant-ineligible multiple myeloma (Abstract 7501).

Prostate Cancer

Christos Kyriakopoulos, MD, on Prostate Cancer: CHAARTED2 Trial Results on Cabazitaxel and Abiraterone

Christos Kyriakopoulos, MD, of the University of Wisconsin Carbone Cancer Center, discusses data suggesting that adding cabazitaxel to abiraterone and prednisone improves progression-free survival in patients with metastatic castration-resistant prostate cancer who previously received chemohormonal therapy with docetaxel for hormone-sensitive disease compared with abiraterone plus prednisone alone (Abstract LBA5000).

Kidney Cancer

Toni K. Choueiri, MD, on RCC: Biomarker Analysis From the CLEAR Trial

Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, discusses phase III findings showing that, in patients with advanced renal cell carcinoma (RCC), the benefit of lenvatinib plus pembrolizumab vs sunitinib in overall response rate does not appear to be affected by such factors as geneexpression signatures for tumorinduced proliferation, PDL1 status, or the mutation status of RCC driver genes.

Breast Cancer

Ana C. Garrido-Castro, MD, on Managing Metastatic Breast Cancer in 2024

Ana C. Garrido-Castro, MD, of Dana-Farber Cancer Institute, discusses recent approvals of multiple novel therapies for metastatic breast cancer, weighing their potential benefits and risks, understanding the mechanisms that drive response and resistance, and exploring how to optimally sequence them to enhance survival and quality of life.

Lung Cancer

Narjust Florez, MD, and Suresh S. Ramalingam, MD, on EGFR-Mutated NSCLC: Update on Osimertinib and Chemoradiotherapy

Narjust Florez, MD, of the Dana-Farber Cancer Institute, and Suresh S. Ramalingam, MD, of Emory University School of Medicine, Winship Cancer Institute, discuss potentially practice-changing phase III results from the LAURA study. This trial showed that osimertinib after definitive chemoradiation therapy improved progression-free survival for patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC), suggesting this agent may represent a new standard of care in this setting (LBA4).