Amgen released its financial results for the fourth quarter and full year 2020. Among the key results, Amgen disclosed that the development of five its oncology candidates have either been paused or altogether abandoned. The programs include the following:
AMG 701 (pavurutamab), a half-life extended BiTE molecule targeting B-cell maturation antigen (BCMA) for relapsed or refractory multiple myeloma. Dose escalation data for AMG 701 were presented at the American Society of Hematology Annual Meeting in December. Enrollment in the Phase 1 study has been paused while Amgen is discussing protocol modifications to optimize safety monitoring and mitigation with the FDA. The company indicated that enrolled patients who are demonstrating benefit may continue to receive AMG701, and patient enrollment is expected to resume in H1 2021.
A phase 1 trial of AMG 673, a half-life extended BiTE molecule targeting CD33, has been paused. Amgen is focusing on another CD33-targeting BiTE molecule, AMG 330, to gather more information on the CD33 program.
The clinical development of AMG 596, a BiTE molecule targeting EGFR variant III for glioblastoma, has been discontinued as part of an effort to reprioritize the company’s R & D portfolio.
The phase 1 development of AMG 387, an oral MCL-1 inhibitor, was paused. Amgen is shifting its focus to the intravenous MCL-1 inhibitor AMG 176, currently in Phase 1 for the treatment of hematologic malignancies. A phase 3 study (MASTERKEY-265/KEYNOTE-034) evaluating Imlygic (talimogene laherparepvec) in combination with pembrolizumab (Keytruda) versus pembrolizumab alone for treatment of unresectable stage IIIB to IVM1c melanoma was stopped for futility after an interim analysis by the Data Monitoring Committee. No new safety signals were observed.