Video
Dr Zhang on Sintilimab Plus Axitinib in FH-Deficient RCC
Author(s):
Xingming Zhang discusses efficacy, safety, and quality of life findings from a phase 2 trial investigating the combination of sintilimab and axitinib in patients with fumarate hydratase–deficient renal cell carcinoma.
Xingming Zhang, West China Hospital, discusses efficacy, safety, and quality of life (QOL) findings from a phase 2 trial (NCT04387500) investigating the combination of sintilimab and axitinib (Inlyta) in patients with fumarate hydratase (FH)–deficient renal cell carcinoma (RCC).
This ongoing phase 2 trial aims to enroll 41 patients who are 18 years of age and older and who have FH-deficient RCC across 8 sites in China. Eligibility criteria include confirmed germline and/or somatic FH large deletions and/or alterations, an ECOG performance score of 2 or lower, and an expected survival of more than 3 months. As of April 2023, the efficacy-evaluable population consisted of 23 patients, and 36 patients were evaluable for safety and quality of life. Patients received 200 mg of sintilimab injection every 3 weeks plus 5 mg of oral axitinib twice a day.
Sintilimab plus axitinib produced an overall response rate of 65.2%, with 13%, 52.5%, 21.7%, and 13% of patients achieving best responses of complete response, partial response, stable disease, and progressive disease, respectively. The average rate of tumor shrinkage was 48%, and the combination elicited a disease control rate of 87%.
Regarding safety, all patients experienced adverse effects (AEs) of any grade, and 25% of patients had grade 3 or higher AEs. The most common AEs included proteinuria, hypertriglyceridemia, increased blood creatinine levels, hypothyroidism, increased adrenocorticotropic hormone levels, and hypothyroidism.
This trial is also evaluating patient-reported outcomes using the Functional Assessment of Cancer Therapy – kidney symptom index-19 (FKSI-19) and the visual analogue scale (VAS), Zhang says. The mean FKSI-19 total score was stable after treatment with sintilimab plus axitinib, with a slight increase after 6 months of treatment. The mean VAS score was also stable after treatment.
The combination of sintilimab and axitinib had a manageable safety profile and generated promising tumor responses in patients with FH-deficient RCC, Zhang concludes.
Disclosures: Dr Zhang reports no disclosures.
