EC 255-446-0
Subcutaneous bispecific (amivantamab + hyaluronidase) approved for adults with recurrent/metastatic head and neck squamous cell carcinoma after platinum and anti‑PD‑(L)1 therapy.
Phase 3 KEYNOTE‑C93: pembrolizumab alone extended median PFS to 38.2 vs 8.4 months versus platinum doublet; results presented at ESMO and published in The Lancet.
Cohort 5 reported 77% confirmed ORR (14% CR) in non‑HPV HNSCC with subcutaneous amivantamab + pembrolizumab and carboplatin; median follow‑up 10.6 months; safety consistent with known profiles.
Phase 3 DeLLphi‑305: IMDELLTRA with durvalumab raised median OS to 21.1 vs 12.7 months, tripled PFS, and produced ~80% one‑year survival versus 53%.
New clinical results include first-in-human data for oral RIPTAC JNJ-6143 in mCRPC, late-breaking PROTEUS Phase 3 prostate results, and expanded RYBREVANT FASPRO datasets across lung and head & neck cancers.
Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.
Tarlatamab (IMDELLTRA) plus durvalumab showed statistically significant OS, PFS and ORR benefits versus durvalumab alone in Phase 3 DeLLphi‑305 for first‑line maintenance ES‑SCLC.
OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.
Three Phase III trials will test DLL3-targeting obrixtamig in SCLC and epNEC, and HER2 TKI zongertinib as adjuvant therapy in resectable HER2‑mutant NSCLC.
FDA accepted an sBLA for adjuvant PD‑L1 therapy plus chemotherapy in stage III dMMR/MSI‑H colon cancer; agency decision expected Oct 9, 2026.
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