Two multi-year collaborative agreements were recently established by Amgen and the University of Texas MD Anderson Cancer Center to advance the development of early-stage investigative therapies in Amgen’s portfolio to treat multiple myeloma and other cancers.
A total of 16 early-stage programs are planned to be launched, covering treatment candidates for myeloma, leukemia, SCLC, and other small-cell cancers.
Three types of therapies will be studied through these programs: Amgen’s bispecific T-cell engaged (BiTE), chimeric antigen receptor (CAR) T-cell, and small molecule candidates.
BiTE antibody constructs and CAR T-cell therapies are both designed to activate a person’s immune system to fight cancer, although they act in different ways. While BiTE constructs work by bridging T-cells to allow the immune system to better attack tumor cells, CAR T-cell therapies re-engineer a patient’s own T-cells to recognize tumor-specific proteins and trigger the immune system to attack cancer cells.
“These agreements build on a long history of collaboration between Amgen and MD Anderson, including a number of different efforts which helped to enable the advancement and regulatory approval of Amgen’s first bispecific T-cell engager,” David M. Reese, MD, senior vice president at Amgen, said in a press release. “We are pleased to work with MD Anderson to accelerate the translation of several of our early-stage oncology programs from the laboratory to the clinic.”
The first five-year collaboration will kick off with a Phase 1 clinical trial designed to study BiTE antibody constructs and CAR T-cell therapies for myeloma and small cell lung cancer. The second four-year collaboration will study BiTE antibody constructs, CAR T-cell therapies, and small molecule treatments in myelodysplastic syndromes and leukemia.
Combined, the agreements will use resources from multiple institutes to conduct preclinical and clinical trials. These studies could potentially help identify new biomarkers.
“The field of immuno-oncology is rapidly evolving and combining resources from both organizations could be important in answering key scientific questions,” said Patrick Hwo, MD, division head of cancer medicine at MD Anderson. “The collaboration allows MD Anderson to study up to 16 different oncology treatments which we hope will lead to rapid development and advancement of important therapies into clinical practice.”
Amgen is the maker of Kyprolis (carfilzomib), which was approved in 2012 by the U.S. Food and Drug Administration as a treatment for advanced myeloma that has worsened despite treatment with Velcade (bortezomib) and another immunomodulatory drug.
In 2015, the FDA approved an expansion of Kyprolis’ original indication to include a combination with Revlimid (lenalidomide) and dexamethasone to treat patients with relapsed myeloma who have previously received at least one prior therapy.
In 2016, the FDA approved another indication expansion for Kyprolis, to include combinations with dexamethasone or Revlimid (lenalidomide) plus dexamethasone in relapsed or treatment refractory myeloma patients.
Amgen in 2017 applied to both the FDA and the European Medicines Agency for permission to change the label again for Kyprolis.
The latest application was based on the results of the Phase 3 ENDEAVOR clinical trial (NCT01568866), which showed that Kyprolis, when given with dexamethasone, lets relapsed myeloma patients live an average of 7.6 months longer than those treated with a combination of Velcade plus dexamethasone.