Immunotherapy in GU Cancers | Specialty

The OncLive Immunotherapy in GU Cancers condition center page is a comprehensive resource for clinical news and expert insights on available and investigational immunotherapies in genitourinary malignancies, specifically prostate cancer, urothelial carcinoma, and renal cell carcinoma. This page features news articles, interviews in written and video format, and podcasts that focus on updates with checkpoint inhibitors and the ongoing research with this type of treatment.

Pembrolizumab/Lenvatinib Approved in Europe for Frontline RCC

November 29th 2021

The European Commission has approved the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced renal cell carcinoma.

CG0070 Plus Pembrolizumab Shows Early Tolerability and Activity in BCG-Unresponsive Non–Muscle Invasive Bladder Cancer

November 29th 2021

The combination of CG0070 and pembrolizumab was well tolerated and demonstrated early signals of activity in patients with Bacille Calmette-Guérin-unresponsive non–muscle invasive bladder cancer.

Nivolumab/Cabozantinib Continues to Showcase Deep, Durable Responses in Advanced RCC

October 11th 2021

Nivolumab plus cabozantinib continued to significantly improve overall response rate vs sunitinib in patients with previously untreated, advanced renal cell carcinoma, with meaningful response outcomes observed irrespective of dose modifications with cabozantinib and fewer responders in the doublet arm requiring subsequent treatment.

FDA Grants Full Approval to Pembrolizumab for Select Locally Advanced or Metastatic Urothelial Cancer

August 31st 2021

The FDA has granted a full approval to pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.

RNAi Therapy ARO-HIF2 Shows Early Activity, Tolerability in Heavily Pretreated Clear Cell RCC

July 7th 2021

The investigational RNA interference therapy, ARO-HIF2, was shown to have encouraging signals of activity with favorable tolerability in heavily pretreated patients with advanced clear cell renal cell carcinoma.

Adjuvant Nivolumab Improves DFS in High-Risk Muscle-Invasive Urothelial Cancer

June 14th 2021

Adjuvant nivolumab led to a significant improvement in disease-free survival compared with placebo in patients with high-risk muscle-invasive urothelial carcinoma following radical surgery, irrespective of PD-L1 expression level.

FDA Panel Endorses Atezolizumab for Frontline Metastatic Urothelial Cancer

April 28th 2021

In a 10 to 1 vote, the FDA’s Oncologic Drugs Advisory Committee voted to support the accelerated approval of atezolizumab for the frontline treatment of patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma.

ODAC Hearings on 6 Immunotherapy Indications Set to Begin

April 26th 2021

The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.

Frontline Nivolumab/Cabozantinib Approved in Europe for Advanced RCC

April 14th 2021

The European Commission has approved the combination of nivolumab and cabozantinib as a frontline treatment in patients with advanced renal cell carcinoma.

CheckMate-9ER Sets the Bar for Research With Triplets, Response-Guided Therapy in mRCC

April 2nd 2021

Data from the phase 3 CheckMate-9ER trial has not only confirmed the advantage of cabozantinib plus nivolumab in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, but it has served as additional incentive to push the needle even further with research aimed at evaluating triplet regimens in the frontline setting and response-guided sequencing strategies.

Checkpoint Inhibition Makes Way Into NCCN Urothelial Cancer Guidelines in Maintenance and Second-Line Setting

March 20th 2021

Immunotherapy is now incorporated into National Comprehensive Cancer Network guidelines as maintenance therapy and in a sequencing strategy for the treatment of patients with metastatic urothelial carcinoma and in the setting of superficial UC-carcinoma in situ with prior intravesical therapy.

FDA Will Reassess 6 Immunotherapy Accelerated Approvals

March 12th 2021

Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.

NEJM Data Underscore Frontline Nivolumab/Cabozantinib Benefit Over Sunitinib in Advanced RCC

March 5th 2021

The combination of nivolumab and cabozantinib showcased significant benefit in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, as was underscored in data from the phase 3 CheckMate-9ER trial.

Cabozantinib/Nivolumab Approaches EU Approval for Frontline Advanced RCC

February 26th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

TKI/Immunotherapy Combos Dominate Frontline Metastatic RCC Management

February 22nd 2021

Claud N. Grigg, MD, highlights different frontline combination regimens that are improving outcomes for patients with metastatic renal cell carcinoma.

Atezolizumab Demonstrates Clinical Activity in PD-L1–High Metastatic Urothelial Carcinoma

February 12th 2021

February 12, 2021 - Atezolizumab monotherapy showed favorable outcomes compared with chemotherapy alone as frontline treatment for patients with cisplatin-ineligible IC2/3 advanced or metastatic urothelial carcinoma.

Frontline Immunotherapy Correlates With Improved OS Over TKIs in Advanced Non–Clear Cell RCC

February 11th 2021

February 11, 2021 - First-line treatment with immune checkpoint inhibitor–based regimens could be linked with an improvement in overall survival versus select targeted therapies in patients with metastatic non–clear cell renal cell carcinoma.

Immunotherapy Finds a Foothold in Metastatic Bladder Cancer, But Frontline Challenges Remain

December 14th 2020

The emergence of checkpoint inhibitors has transformed the second-line treatment of patients with metastatic bladder cancer. However, questions regarding the utility of immunotherapy in the frontline setting remain unanswered, leaving chemotherapy as the standard-of-care option.

ctDNA Positivity Correlates With Improved Survival With Atezolizumab in High-Risk Muscle-Invasive Bladder Cancer

December 12th 2020

Circulating tumor DNA positivity identified patients with high-risk muscle-invasive urothelial cancer who were likely to derive improvements in disease-free survival and overall survival from adjuvant atezolizumab vs observation.

Choosing Among First-Line IO/TKI Combos in RCC: The Affordable Option Is the Winner

November 7th 2020

Combination regimens comprised of immunotherapy and TKI inhibitors have yielded significant benefits in terms of overall survival and progression-free survival with acceptable safety in patients with renal cell carcinoma; however, the cost of these regimens may negate the impact of these advances.