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New Drug: Retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)

New Drug: Retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
Study:
  • Open-label, multicenter, single-arm, phase 2 study
  • Treatment naïve metastatic or recurrent locally advanced MCC
  • Retifanlimab q28 (n=65)
Efficacy:
  • ORR: 52% [40.0%-65.0%]; cR:18%
  • DOR ≥6 mos: 76% [26 pts of 34]
  • DOR ≥12 mos: 62% [21 pts of 34]
Safety:
  • Any grade AEs: Fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761334Orig1s000correctedlbl.pdf

Reviewed by Elvin CHALABİYEV, MD on APR 17, 2023

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