The data from the abstract of the study at ASCO shows that Keytruda plus chemo improved progression-free survival (PFS) to 9.7 months, compared to 5.6 months for chemo alone, which was a statistically significant improvement. There was a trend towards improved PFS in patients with low...
Primary efficacy outcome measures were OS as well as progression-free survival (PFS) and objective response rate (ORR) as assessed by blinded independent central review (BICR) using RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ....
“This approval is an important step forward in helping patients fight this difficult-to-treat malignancy, as physicians can now provide an option that may improve survival outcomes.” “When compared to the chemotherapies used in this trial, this co...
Aetna considers pembrolizumab (Keytruda) medically necessary for treatment of the following indications: Ampullary adenocarcinoma - as a single agent for microsatellite instability-high (MSI-H), mismatch repair deficient (dMMR), or tumor mutational burden-high (TMB-H greater than or equal to 10 muta...
The combo produced similar success in progression-free survival (PFS), reducing the risk of disease progression or death by 55%. Patients on the combo regimen lived a median of 12.5 months without progression, versus 6.3 months for the chemo arm. ...
The study also showed that the 1-year overall survival rate was 81.6%. However, Rosenberg was quick to note that the trial was only a 45-patient trial and that the trial needed to be expanded to see how more patients with metastatic urothelial carcinoma responded to the treatment. More...