A New Therapeutic Approach May Make Waves in Kidney Cancer Treatment

At the 2025 ASCO Annual Meeting, key updates in the treatment of various cancers were shared with physicians and patients, including the treatment of newly diagnosed clear cell renal cell carcinoma, a type of kidney cancer. One such update for this patient population was from the phase 1b STELLAR-002 trial, according to Dr. Michael Serzan.

In an interview with CURE, Serzan walked through the key takeaways from the trial, what these outcomes mean for patients, and what next steps are for this combination, given these are still early days for the study.

Serzan is a medical oncologist in the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, as well as an instructor of medicine at Harvard Medical School, located in Boston.

Transcript:

To kick things off, what updates were shared at the 2025 ASCO Annual Meeting from the phase 1b STELLAR-002 study for patients who are newly diagnosed with clear cell renal cell carcinoma?

First, thank you so much for having me and for hosting this very important session to better inform patients and their caregivers about updates from ASCO 2025. My name is Dr. Michael Serzan, and I am a medical oncologist at the Dana-Farber Cancer Institute. I'm happy to walk through the STELLAR-002 study.

For some context, this study was conducted for patients with metastatic kidney cancer, meaning cancer that had spread to distant parts of the body. We are very fortunate to have many treatment options that have not only helped patients live better, but also live longer. This particular study aimed to investigate a new combination of therapies designed not only to shrink cancer, but hopefully to achieve long-term control. It looked at the safety, tolerability, effectiveness of the drugs, and how long patients remained on the study.

The STELLAR-002 study was a phase 1 trial that utilized the new VEGF TKI (Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor), zanzalintinib (XL092). This medication primarily targets the blood supply of clear cell kidney cancer and is very similar to a drug called Cabometyx (cabozantinib), which is one of our foundational treatments for kidney cancer patients. The key difference is that zanzalintinib has a much shorter half-life. This means if patients experience side effects and need to discontinue therapy, we can stop the drug, and those side effects may resolve more quickly.

The STELLAR program combined zanzalintinib with Opdivo (nivolumab), which is one of our standard immunotherapies. The second arm of the study looked at zanzalintinib plus Opdivo and Opdualag (relatlimab-rmbw), a new immunotherapy drug that targets the LAG-3 receptor on the surface of immune cells. The study was truly trying to determine if there were differences in how well the drugs were tolerated and how effective they were at treating the cancer when comparing the zanzalintinib/Opdivo arm versus the zanzalintinib/Opdivo/Opdualag arm.

Transcript has been edited for clarity and conciseness.

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