Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval as Monotherapy for Patients with Unresectable or Metastatic Tumor Mutational Burden-High Solid Tumors

 Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval as Monotherapy for Patients with Unresectable or Metastatic Tumor Mutational Burden-High Solid Tumors

Merck, Keytruda, pembrolizumab, Receives, US, FDA, Approval, Monotherapy, Patients, Unresectable, Metastatic, Tumor, Mutational, Burden-High Solid Tumors

Shots:

  • The accelerated approval is based on KEYNOTE-158 study assessing Keytruda (200mg, q3w). In a study, 1,050 patients were included in the efficacy analysis population in which TMB was analyzed in the subset of 790 patients with sufficient tissue for testing based on protocol-specified testing requirements, out of 790, 102 had tumors identified as TMB-H, defined as TMB ≥10 mut/Mb
  • Results: In patients whose tumors were TMB-H, ORR (29%); CR (4%); PR (25%); after a median follow-up time of 11.1 mos. mDOR (not reached). In a pre-specified analysis of patients with TMB ≥13 mut/Mb: ORR (37%); CR (3%); PR (34%), In an exploratory analysis in 32 patients whose cancer had TMB ≥10 mut/Mb & <13 mut/Mb, the ORR (13%); median duration of exposure (4.9mos.)
  • The FDA also approved FoundationOne CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H (≥10 mutations/ megabase) who may benefit from immunotherapy treatment with Keytruda monotherapy

Click here to read full press release/ article | Ref: Buinesswire | Image: Merck

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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