A new Phase 2 clinical trial will begin this year to explore NKT2152 (a HIF2a-inhibitor) in combination with Fotivda/Tivozanib (a VEGFR tyrosine kinase inhibitor) as a treatment for relapsed/refractory clear cell renal cell carcinoma (RCC) patients.
This study is based on preclinical and clinical data which showed an improved anti-tumor activity when using the combined treatments in patients.
Researchers are hopeful that the unique qualities of both of these compounds will provide improved benefits for patients.
HIF2a Inhibitors
HIF2a inhibitors gained a lot of attention in RCC when belzutifan was approved by the FDA in 2021 for von Hippel-Lindau (VHL) disease-associated RCC.
Belzutifan’s approval was based on a Phase 2 clinical trial which demonstrated positive results in RCC. Among 61 patients diagnosed with VHL-associated RCC, the therapy produced an objective response rate of 49%.
NKT2152 is a different HIF2a inhibitor, and researchers are hopeful about its potential in RCC.
Tivozanib
Tivozanib first received FDA approval in 2021 for those diagnosed with RCC who had already been treated with at least two other systemic therapies.
The FDA approval was thanks to positive data from a Phase 3 clinical trial called TIVO-3. This trial demonstrated that tivozanib was able to improve progression-free survival significantly. When compared to sorafenib, there was more improvement when tivozanib was used. However, there were similar overall survival rates between the two treatments.
For a median follow-up for the tivozanib group of 38 months, there was a median overall survival of 16.4 months. For a median follow-up for the sorafenib group, there was a median overall survival of 19.2 months. Additionally, the median progression-free survival for the tivozanib group was 5.6 months and the median progression-free survival for the sorafenib group was 3.9 months.
This study also found that patients who had received a VEGF inhibitor and a checkpoint inhibitor, or two VEGF TKIs in the past had the greatest results of all patients.
You can read more about these studies and the potential combination treatment here.
