other material
confidence high
sentiment positive
materiality 0.70
Scholar Rock reports positive SRK-181 Phase 1 data across multiple tumors; ccRCC ORR 23.3%
Scholar Rock Holding Corp
- SRK-181 + pembrolizumab showed ORR 23.3% in ccRCC, 27.3% in melanoma, 18.2% in HNSCC, 9.1% in UC; no NSCLC response.
- Safety manageable: no Grade 5 AEs; most common AEs were rash, pruritus, fatigue; one Grade 4 dermatitis exfoliative.
- Biomarker analysis in ccRCC: baseline CD8+ infiltration doubled ORR to 40%; elevated Treg levels raised ORR to 50%.
- Company plans end of Phase 1 meeting with FDA and evaluating partnership opportunities for SRK-181.