Keytruda in combination with Inlyta as first-line treatment for patients with advanced renal cell carcinoma, approved by FDA
The U.S. Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, in combination with Inlyta ( Axitinib ), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma ( RCC ).
The approval is based on findings from the pivotal phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival ( OS ), progression-free survival ( PFS ) and objective response rate ( ORR ) for Pembrolizumab in combination with Axitinib ( Pembrolizumab-Axitinib combination ) compared to Sunitinib.
Consistent results were observed across pre-specified subgroups, IMDC risk categories and PD-L1 tumor expression status.
For the main efficacy outcome measures of OS and PFS, the Pembrolizumab-Axitinib combination has reduced the risk of death by 47% compared to Sunitinib ( hazard ratio, HR=0.53 [ 95% CI, 0.38-0.74 ]; p less than 0.0001 ); for PFS, the Pembrolizumab-Axitinib combination has shown a reduction in the risk of progression of disease or death of 31% compared to Sunitinib ( HR=0.69 [ 95% CI, 0.57-0.84 ]; p=0.0001 ).
The ORR, an additional efficacy outcome measure, was 59% for patients who received the Pembrolizumab-Axitinib combination ( 95% CI, 54-64 ) and 36% for those who received Sunitinib ( 95% CI, 31-40 ) ( p less than 0.0001 ).
Immune-mediated adverse reactions, which may be severe or fatal, can occur with , including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation ( HSCT ).
Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered if appropriate.
Keytruda can also cause severe or life-threatening infusion-related reactions.
Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman.
Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. ( Xagena )
Source: Merck, 2019