Dr. Jonasch on the Safety Profile of MK-6482 in Von Hippel-Lindau Disease–Associated RCC

Eric Jonasch, MD, professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the safety profile of the investigational oral hypoxia-inducible factor (HIF)-2α inhibitor MK-6482 in Von Hippel-Lindau disease–associated renal cell carcinoma (RCC).

At the 2020 ASCO Virtual Scientific Program, findings from a phase 2 study (NCT03401788) of MK-6482 demonstrated promising clinical activity in treatment-naïve patients with this subtype of RCC.

Regarding safety, any-grade anemia was observed in 86.9% of 61 evaluable patients, says Jonasch. Additionally, 3.3% of patients had grade 3 anemia and none had grade 4 or 5 anemia.

Anemia was found to be an on-target toxicity as erythropoietin (EPO) is a HIF-2α–associated gene, explains Jonasch. While the majority of patients did not require additional intervention for anemia, patients who did were well managed by external EPO or blood transfusion.

Any-grade and grade 3 fatigue was observed in 57.4% and 4.9% of patients, respectively. Investigators were unable to conclude whether the fatigue was a treatment-related adverse effect or a bystander effect, concludes Jonasch.