Amgen R&D Highlights
Drug	Status And Upcoming Milestones
Lumakras (sotorasib)	Data from a Phase III confirmatory study of the KRAS G12C inhibitor in lung cancer testing monotherapy versus chemotherapy are expected in the third quarter of 2022, while data from earlier studies in combination with checkpoint inhibitors and SHP2 inhibitors are expected in lung cancer in mid-2022. Data from additional lung cancer combinations are expected in 2022 and 2023. A Phase III trial testing Lumakras with Vectibix in colorectal cancer is under way. Data from a Phase I/II monotherapy study in pancreatic cancer will be reported on 14 February. Combination therapy studies are ongoing in pancreatic and colorectal cancers. (Also see "First Lumakras Combo Data Show Boosted Efficacy For Amgen Drug In CRC" - Scrip, 17 September, 2021.)
Tezspire (tezepelumab)	A Phase III program with the TSLP inhibitor is ongoing in chronic rhinosinusitis with nasal polyps, Phase III planning under way in eosinophilic esophagitis, Phase II studies ongoing in chronic spontaneous urticaria and chronic obstructive pulmonary disease. (Also see "Amgen Expects Quick, Broad Adoption Of Tezspire In Severe Asthma" - Scrip, 20 December, 2021.)
AMG 451	Phase III studies of the OX40-targeting drug in atopic dermatitis will launch in mid-2022. (Also see "Sanofi And Amgen Make The Case For OX40 Drugs In Atopic Dermatitis" - Scrip, 4 October, 2021.)
Efavaleukin alfa (AMG 592)	Phase IIb studies of the interleukin-2 (IL-2) mutein are under way in systemic lupus erythematosus (SLE) and ulcerative colitis.
Rozibafusp alfa (AMG 570)	A Phase IIb study of this drug – a bispecific antibody-peptide conjugate that blocks both inducible T-cell costimulatory ligand (ICOSL) and B-cell activating factor (BAFF) – is ongoing in SLE.
Tarlatamab (AMG 757)	A potentially registrational Phase II study in third-line small cell lung cancer is enrolling patients for monotherapy treatment with the half-life-extended (HLE) bispecific T-cell engager (BiTE) targeting delta-like ligand 3 (DLL3). Earlier studies are planned to test combination therapy and sequential approaches to move tarlatamab into earlier lines of therapy in SCLC. A Phase I study is under way in neuroendocrine prostate cancer.
Bemarituzumab	Two Phase III trials of the fibroblast growth factor receptor 2b (FGFR2b) inhibitor in first-line gastric cancer are under way. Amgen also is launching a signal-seeking trial in squamous cell carcinoma of the lung and plans to launch a basket trial in the second quarter of 2022 in other solid tumors with FGFR2b overexpression. (Also see "Amgen After ASCO: Questions Remain On Lumakras, Bemarituzumab" - Scrip, 8 June, 2021.)
Acapatamab (AMG 160)	Phase I results are expected by mid-2022 in prostate cancer. This drug is an HLE BiTE targeting prostate specific membrane antigen (PSMA) and CD3.
AMG 340 (TNB 585)	Phase I data in prostate cancer are expected by mid-2022. The drug is a different type of bispecific T-cell engager targeting PSMA and CD3.
AMG 509	Full Phase I first-in-human data to be presented later this year or early next year; acceleration of development is planned. The bivalent T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) is being developed in partnership with Xencor, Inc.
Olpasiran	The drug is a small interfering RNA (siRNA) designed to lower lipoprotein(a), or Lp(a). Phase IIb data are expected in the first half of 2022 to inform the design of a registrational Phase III program in atherosclerotic cardiovascular disease.
AMG 133	The multi-specific drug is designed as a glucagon-like peptide 1 (GLP-1) agonist and a gastric inhibitory polypeptide receptor (GIPR) antagonist. A Phase I trial is ongoing and early data has shown weight reduction. Further data will inform future development in cardiovascular disease.

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