Shots:

• Approval is based on the 1st interim analysis of the P-III trial (KEYNOTE-716) assessing Keytruda vs. PBO showed a significant improvement in RFS and reducing the risk of disease recurrence or death by mRFS was not achieved in both groups. After a 14.4 mos. median follow up, death is 11% (n=54/487) vs 17% (n=82/489)
• This P-III trial (KEYNOTE-716) enrolled 976 patients with completely resected stage IIB or IIC melanoma as adjuvant therapy. Patients received Keytruda (200 mg or the pediatric dose 2 mg/kg, IV, Q3W) or PBO for up to one year until disease recurrence or unacceptable toxicity. The RFS was the main efficacy outcome measure assessed
• Keytruda is a humanized monoclonal antibody that expand the ability of T lymphocytes to help detect and fight tumor cells

Ref: Businesswire | Image: Merck