Immunotherapy in GU Cancers | Specialty

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.