Pembrolizumab
Stories
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FDA approves pembrolizumab or Keytruda Qlex for TMB-H solid tumors
On October 16, 2026, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors defined as ≥13 mutations/megabase. The approval converts the prior accelerated approval and amends the TMB-H definition to ≥13 mut/Mb, as efficacy was not confirmed in patients with TMB of 10 to <13 mut/Mb.
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Pembrolizumab plus chemotherapy prolongs PFS versus monotherapy in high-PD-L1 NSCLC
In the PERSEE phase III trial, 321 patients with stage IV or unresectable stage III NSCLC and PD-L1 ≥50% were randomized to pembrolizumab alone or with platinum-based chemotherapy. Median progression-free survival was 16.1 months with combination versus 6.9 months with monotherapy (HR 0.56, 95% CI 0.43-0.74; P<0.001).
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Merck posts results of Phase III KEYNOTE-522 trial in triple negative breast cancer
The study enrolled 1,174 participants and compared pembrolizumab plus chemotherapy to placebo plus chemotherapy as neoadjuvant therapy, followed by pembrolizumab or placebo as adjuvant therapy. Results were first posted on ClinicalTrials.gov on October 22, 2026.