Kidney Cancer

The study will evaluate the investigational drug product ONC175 (orellanine) in patients with metastatic clear cell or papillary renal cell carcinoma.

“What we hope overall is that this is a biological study that might inform therapeutic development for this disease,” says David A. Braun, MD, PhD.

A recap of the FDA submissions and regulatory decisions in urology from February 2025.

"At ASCO GU, we presented the final analysis of the study, which confirmed the superiority of a combination over the TKI monotherapy in terms of both progression-free survival as well as overall survival," says Camillo Porta, MD.

Robert J. Motzer, MD, reported that median PFS was 16.4 months in the nivolumab plus cabozantinib arm (95% CI, 12.5-19.3) vs 8.3 months in the sunitinib arm (95% CI, 7.0-9.7) (HR=0.58, 95% CI, 0.49-0.70).

The conditional approval of belzutifan is valid for 1 year, with the opportunity for yearly renewal pending forthcoming data.

“Over 80% of patients…had at least 2 lines of therapy, so this is a heavily refractory population,” said Toni K. Choueiri, MD, FASCO.

ORR was 70% (95% CI, 55-82) in cohort 1 compared with 31% (95% CI, 19-45) in cohort 2.

"The take-home point from our study of these 92 patients is that in metastatic kidney cancer, there's a high concordance [between] MRD positivity and patients having progressive disease," says Alan Tan, MD.

At a median follow-up of 40.2 months post-surgery, no patients had experienced a disease recurrence.

A list of facts and trends to know about the current landscape of urologic cancer management and research in the US.

"What we show in our research is that cancers develop in different ways, depending on what the underlying genetic change is," says Taryn Treger.

At a median follow-up of 24.3 months, the confirmed objective response rate was 70%.

Among those with Signature II tumors, overall survival was improved among those who received nivolumab compared with those who received everolimus.

As the year comes to a close, we revisit some of this year’s top content on the management of renal cancer.

Initial data from the trial are expected to be released in the first half of 2025.

A final decision on marketing authorization is anticipated for Q1 of 2025.

Initial results on ADI-270 are anticipated for the first half of 2025.

Overall, 76% of patients with a CD70 TPS of at least 50% achieved a reduction in tumor burden.

“Based on these data, casdatifan has the potential to be a future treatment option for kidney cancer," says Toni K. Choueiri, MD.

The RMAT designation is supported by interim data from the ongoing phase 1 TRAVERSE trial.

Zaorsky discusses his team's ASTRO 2024 abstract showing clear benefit of radiotherapy and ablation in reduced kidney effects in patients with RCC.

"The encouraging results suggest that alternating pazopanib with bevacizumab is a promising treatment regimen for renal cell carcinoma patients in the favorable risk group," says Saby George, MD, FACP.

According to the authors, "These results support the use of Benmelstobart plus anlotinib as a new first-line treatment for advanced RCC.”

The TiNivo-2 trial demonstrated that rechallenging ICI therapy does not improve outcomes in patients with renal cell carcinoma.

On Cox regression analysis, glycoproteins were predictive of PFS response to nivolumab plus cabozantinib vs sunitinib (P < .01).

"It clearly shows that blocking HIF-2α is a meaningful way of interacting with disease biology in clear cell renal cell carcinoma," says Eric Jonasch, MD.

Late-breaking data from ESMO 2024 suggest ipilimumab / nivolumab may be a new standard of care for non-clear cell renal cell cancer.

“Our study highlights critical gaps in health care equity when it comes to treatments that have been shown effective in prolonging survival,” says Solomon Woldu, MD.

"Overall, we found that patients with recurrent RCC following adjuvant IO continued to have responses to different types of first-line systemic therapy," says Talal El Zarif, MD.