IMDELLTRA Hits 1,600+ Sites After 2025 Approval; LUMAKRAS Delivers 55% ORR
IMDELLTRA achieved full U.S. approval in 2025 for second-line small cell lung cancer, is administered at over 1,600 U.S. sites and approved in Japan. LUMAKRAS triplet data showed ~55% ORR and >90% disease control in colorectal cancer, prompting a first-line study and CodeBreaK 202 phase III trial.
1. IMDELLTRA Commercial Momentum
IMDELLTRA received full U.S. approval in 2025 for second-line small cell lung cancer, has been adopted at over 1,600 U.S. sites and holds approval in Japan. Amgen is conducting multiple phase III trials—including first-line maintenance, first-line combination and limited-stage studies—and is exploring subcutaneous dosing and alternative schedules to improve patient convenience.
2. LUMAKRAS Early-Line and Colorectal Data
LUMAKRAS is approved in second-line non-small cell lung cancer and third-line colorectal cancer in combination with Vectibix. A triplet regimen of LUMAKRAS, Vectibix and FOLFIRI produced ~55% objective response rate and >90% disease control in colorectal patients, leading to a first-line colorectal trial and the Phase III CodeBreaK 202 study in KRAS G12C NSCLC.
3. T-Cell Engagers and Precision Small Molecules
Amgen outlined two R&D pillars: T-cell engagers and precision small molecules targeting difficult mutations like KRAS and PRMT5. The company is the only one with an approved T-cell engager in both hematologic and solid tumors and plans to expand into more common solid cancers while selectively adding modalities such as antibody-drug conjugates.
4. Blinatumomab and Other Modalities
Amgen is moving BLINCYTO (blinatumomab) into earlier therapy lines, evaluating a subcutaneous formulation in a Phase Ib trial and pursuing chemotherapy-sparing regimens in older adults with B-ALL. The company is also exploring BLINCYTO in autoimmune diseases and advancing xaluritamig in prostate cancer with a focus on overall survival differentiation.