Home Resources Key updates in GU tumors

Key updates in GU tumors

4 mins read
6 April 2023

Renal Cell Carcinoma
Key data readouts/events

  • March 2023: Phase III CONTACT-03 study evaluating CABOMETYX (cabozantinib) plus TECENTRIQ (atezolizumab) vs. cabozantinib alone, failed to meet its primary PFS endpoint in locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) RCC that has progressed during or after immune CPI therapy.
  • February 2023: Subgroup analyses from the Phase III KEYNOTE-564 study of adjuvant KEYTRUDA (pembrolizumab) reported prolonged DFS compared with placebo for all subgroups. Results of this exploratory analysis further supports the use of adjuvant pembrolizumab after nephrectomy as a SoC for RCC at increased risk of recurrence.
  • February 2023: Three year follow up of the Phase III CheckMate9ER trial evaluating OPDIVO (nivolumab) plus CABOMETYX (cabozantinib) vs. SUTENT (sunitinib) for the 1L treatment of advanced RCC, reported improved responses and survival outcomes.


Bladder cancer
Key approvals and findings

  • April 2023: The FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv) in combination with KEYTRUDA (pembrolizumab) for treatment of cisplatin ineligible locally advanced or metastatic urothelial cancer. Accelerated approval was based on tumor response rate and durability of response reported in EV- 103 trial. Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial.
  • December 2022: FDA approved ADSTILADRIN (nadofaragenefiradenovec-vncg), an adenoviral vector-based gene therapy for high-risk BCG unresponsive NMIBC with CIS with or without papillary tumors. Efficacy was evaluated in Phase III Study CS-003.

Key data readouts/events

  • March 2023: FDA granted fast-track designation for IK-175, a novel aryl hydrocarbon receptor (AHR) antagonist, in combination with immune checkpoint inhibitors in patients with advanced urothelial carcinoma progressed on checkpoint inhibitors.
  • February 2023: Three-year median follow-up results from the Phase III CheckMate -274 trial reported, significantly improved DFS, non-urothelial tract RFS, DMFS and PFS2 with adjuvant OPDIVO (nivolumab) vs. placebo in radically resected, high-risk muscle-invasive urothelial carcinoma patients including patients whose tumor cells express PD-L1 ≥1%.
  • February 2023: Phase II KEYNOTE-057 trial of KEYTRUDA (pembrolizumab) monotherapy reported notable antitumor activity from cohort B (papillary tumors without CIS) in BCG-unresponsive high-risk NMIBC after ~45 months of follow-up (ASCO GU 2023, Abs#LBA442).
  • February 2023: Primary data from cohort 2 (platinum-ineligible mUC that progressed after prior checkpoint inhibitor therapy) of Phase II TROPHY-U-01 study of TRODELVY
    (sacituzumab govitecan) reported a high response rate with an overall manageable safety profile in platinum-ineligible patients with mUC who progressed after CPI therapy (ASCO GU 2023, Abs#520).
  • January 2023: FDA granted fast track designation to BT8009, a bicycle toxin conjugate targeting Nectin-4 evaluated in phase I/II study for the treatment of previously treated locally advanced or metastatic urothelial cancer.


Prostate cancer
Key approvals and findings

  • February 2023: New Drug Application (NDA) submitted to the U.S. FDA seeking approval of Niraparib and abiraterone acetate dual-action tablet, plus prednisone, as a first-line targeted treatment of BRCA+ mCRPC. The NDA is supported by data from the Phase III MAGNITUDE study.
  • December 2022: European Commission approved LYNPARZA (olaparib) in combination with abiraterone and prednisone/prednisolone for the treatment of mCRPCpatients for whom chemotherapy is not clinically indicated. The approval came after positive results from the Phase III PROpel trial.
  • December 2022: European Commission approved PLUVICTO (lutetium-177) plus ADT with/without androgen receptor (AR) pathway inhibition, for PSMA+ mCRPCprior treated with AR pathway inhibition and taxane-based chemotherapy. The approval was based on the results from the pivotal Phase III VISION trial.

Key data readouts/events

  • February 2023: Phase III KEYNOTE-641 trial evaluating KEYTRUDA (pembrolizumab) plus enzalutamide and ADT for the treatment of mCRPCis to be discontinued by Merck following data from the interim analysis. The combination did not show rPFSand OS benefit compared to placebo plus enzalutamide and ADT.
  • February 2023: The final results of key secondary OS endpoint from the Phase III PROpel trial in mCRPC were presented at ASCO GU 2023. Results reported numerically increased but statistically non-significant mOS for Lynparza (olaparib) plus abiraterone vs. abiraterone alone.
  • January 2023: Merck terminated the Phase III KEYNOTE-991 trial investigating KEYTRUDA (pembrolizumab) plus XTANDI (enzalutamide) and ADT for the treatment of mHSPC patients. The planned interim analysis demonstrated no rPFS or OS benefit with the KEYTRUDA study arm compared to the control group.

Find out more about our therapy area knowledge.

Sign up to receive Rapport.

Rapport is our monthly newsletter where we share our latest expertise and experience.