The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion on the use of avelumab in combination with axitinib for first-line treatment of advanced renal cancer through the Early Access to Medicines Scheme (EAMS).
This positive scientific opinion was issued to Merck Serono Ltd for adult patients with advanced renal cell carcer (RCC) who have not received prior systemic therapy. The scientific opinion includes a public assessment report and treatment protocol.
To register a patient with the EAMS, healthcare professionals (HCPs) will need to register on the Inceptua portal. Once registered they will be able to complete a Patient Access Form, drug supply information, and agreement on their responsibilities within the EAMS. Further information and documentation are available within the Inceptua EAMS portal.
Merck/Pfizer will arrange the required training on adverse event reporting and risk minimisation for immune-related toxicities. Access to training can be arranged by contacting EAMSRCC@merckgroup.com or EAMS-RCC@pfizer.com.
The efficacy and safety of avelumab in combination with axitinib was evaluated in the randomised, multicentre, open-label B9991003 study which included 886 patients with untreated advanced or metastatic RCC.
The study reported median progression-free survival (PFS) of 13.8 months (95% CI 11.1-NE) and 7.2 months (95% CI 5.7- 9.7) for patients with PD-L1- significant positive tumours randomised to avelumab with axitinib, and sunitinib, respectively. A statistically significant improvement in PFS was also demonstrated in all patients, irrespective of PD-L1 expression.
At the time of the first interim analysis, the OS data were still immature, with an observed hazard ratio [HR] of 0.78 (95% CI 0.554-1.084).