Evaluating Belzutifan for Clear Cell Renal Cell Carcinoma Treatment

Jaime Merchan, MD, professor, co-leader of the Translational and Clinical Oncology Research Program and director of the phase 1 clinical trials program at the Sylvester Comprehensive Cancer Center at the University of Miami, discusses the efficacy results observed in the LITESPARK-013 trial (NCT04489771) of belzutifan (Welireg), a hypoxia-inducible factor (HIF)–2α inhibitor, in patients with advanced clear cell renal cell carcinoma (RCC).

The study is comparing the efficacy and safety of 2 doses of belzutifan in patients with advanced RCC with clear cell components following prior therapy. Patients must have had measurable disease per RECIST 1.1 as assessed by BICR, have received received no more than 3 prior systemic regimens for locally advanced or metastatic RCC, have received only 1 prior anti-PD-1/L1 therapy for locally advanced or metastatic RCC, and have recovered from all adverse events from previous therapies to at least grade 1 or baseline. In addition, a Karnofsky performance status score of at least 70% assessed within 10 days prior to the first dose of study intervention was required for enrollment.

When given at the recommended phase 2 dose of 120 mg daily, belzutifan generated similar toxicities and efficacy outcomes vs the daily 200-mg dose of the agent in patients with advanced clear cell RCC.

Merchan then describes some of the future research that is ongoing and next steps for evaluating belzutifan in this patient population.

Transcription:

0:09 | In this pooled analysis, there were no correlations, or no clear correlation, between efficacy on any specific subgroup, which suggests that belzutifan produces a long lasting benefit and responses, regardless of the subgroups analyzed in RCC.

0:33 | Future studies that are currently going on are combination studies of belzutifan with TKIs [tyrosine kinase inhibitors] or checkpoint inhibitors in not only in the second-line, but also in the first-line setting. And moreover, there are upcoming studies using belzutifan in the adjuvant setting in combination with pembrolizumab [Keytruda]. This is actually a phase 3, randomized study that is almost completed, and we are awaiting the results.