Pembrolizumab (Keytruda) has been registered for use in combination with tyrosine kinase inhibitor axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma.
It represents the fifteenth indication for MSD’s checkpoint inhibitor in Australia.
The TGA registration is based on the results of the KEYNOTE-426 trial, published in the NEJM last year, which compared the use of pembrolizumab-axitinib with sunitinib for the first-line treatment of advanced renal cell carcinoma.
The study showed pembrolizumab-axitinib reduced the risk of death by 47% compared to sunitinib (HR 0.53, 95% CI, 0.38 to 0.74; p<0.0001) and significantly increased progression-free survival (15.1 v 11.0 months; HR 0.69; 95%CI, 0.56 to 0.84; p<0.001).
The overall frequency of grade 3 or more treatment-related adverse events was 62.9% in the pembrolizumab–axitinib group and 58.1% in the sunitinib group.
A statement from pharmaceutical company MSD said pembrolizumab-axitinib, can be used as first-line treatment in patients with advanced RCC in all three International Metastatic RCC Database Consortium (IMDC) risk group categories.
About one in three patients with renal cell carcinomas were diagnosed at an advanced stage.
“This latest indication for advanced renal cell carcinoma is a significant step forward for the 3800 Australian patients that are diagnosed with this disease each year,” it said.
“The registration of Keytruda in combination with axitinib for advanced renal cell carcinoma will provide Australian patients and clinicians with another treatment option for this difficult-to-treat cancer,” medical oncologist Associate Professor Andrew Weickhardt, from the Olivia Newton-John Cancer Research Institute, said.