Dr Zhang on Sintilimab Plus Axitinib in FH-Deficient RCC

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.