Efficacy, Safety of Camrelizumab, Apatinib in aRCC After First-line TKI Therapy

Prior research has shown that the combination of immunotherapy and antiangiogenic agents may benefit patients with advanced renal cell carcinoma (aRCC). While apatinib, a vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor (TKI), has demonstrated efficacy as a therapy for aRCC, the efficacy of camrelizumab, a PD-1 inhibitor, has not been determined.

Research from Pei Dong, MD, and colleagues presented at the 2024 American Society of Clinical Oncology Annual Meeting investigated the safety and efficacy of camrelizumab plus apatinib in patients with aRCC who reported the failure of first-line TKI therapy.

The single-arm, phase 2 study investigated the data of 35 patients with aRCC who received camrelizumab 200 mg intravenously once every 2 weeks and apatinib 250 mg once per day until reaching disease progression or unacceptable toxicity. Patients underwent treatment with camrelizumab for a maximum of 2 years.

The primary end point was progression-free survival (PFS) in accordance with Response Evaluation Criteria in Solid Tumors version v1.1.

Investigators found that the median follow-up period was 16.5 months at the study’s cutoff date. Twelve (34.3%) patients achieved a partial response, while 17 (48.6%) reported stable disease, which led to an objective response rate of 34.3% (95% CI, 19.1-52.2) and a disease control rate of 82.9% (95% CI, 66.4-93.4).

Of the patients with progressive disease (PD), 2 of 5 demonstrated increased benefits following treatment with camrelizumab plus apatinib for more than 4 months following initial PD. Dr. Dong and colleagues reported that the median overall survival was 28.4 months (95% CI, 19.7-not reached), and median PFS was 10.0 months (95% CI, 6.1-14.9).

Twenty-seven (77.1%) patients reported treatment-related adverse events (TRAEs) higher than grade 3. The most reported TRAEs included proteinuria (25.7%), hypertension (20.0%), and increased alanine aminotransferase (14.3%) and aspartate aminotransferase (14.3%).

“The combination of camrelizumab and apatinib demonstrates encouraging antitumor activity and a favorable safety profile as a second-line treatment option for patients with aRCC,” the researchers wrote.