Ipsen announced the registration of a new anticancer drug in Russia, cabosantinib. The drug is intended for the treatment of advanced renal cell carcinoma (RCC) in adult patients with intermediate or poor prognosis who have not received previous systemic therapy, and in adult patients after previous treatment with targeted drugs against vascular endothelial growth factor (VEGF).
Cabozantinib belongs to a new generation of tyrosine kinase inhibitors. It blocks the action of such important components of tumor progression as VEGFR, MET, AXL, thereby inhibiting tumor angiogenesis, invasiveness, metastasis and drug resistance. The drug is produced in tablets at a dosage of 20, 40 and 60 mg. Cabozantinib is registered in the USA and Europe since 2016.
In clinical studies, cabosantinib showed superior efficacy compared to standard sunitinib therapy in previously untreated patients with advanced RCC with intermediate and poor prognosis. Using formalin-fixed paraffin-embedded baseline tumour tissue obtained from 110 patients participating in CABOSUN and 306 patients from METEOR, the investigators assessed PD-L1 expression in both tumour cell and immune cell by performing immunohistochemical double-staining for PD-L1 and CD45/CD163 (immune cell markers).
The percentages of PD-L1-positive tumour or immune cells were assessed by image analysis. Comparison of the overall response rate (ORR) by RECIST between PD-L1-positive, using ≥1% as cut-off, versus PD-L1-negative tumours was done by Fisher’s exact test and Cox regression was used to correlate progression-free survival (PFS) and overall survival (OS) with tumour PD-L1 expression across each treatment arm. The ORR, PFS and OS were per independent central review (ICR).