Amgen is pausing and stopping a whole series of next-gen cancer assets as it tries to figure out the best way forward for its early oncology programs.
Buried in its annual financial results, released Tuesday night, is evidence the Big Pharma, which is hoping for success and approval with its closely watched KRAS hopeful sotorasib, is having a tougher time making its other next-gen assets work.
There is a slew of updates here: First up is AMG 701 (aka pavurutamab), a half-life extended BiTE molecule targeting B-cell maturation antigen for relapsed or refractory multiple myeloma, which saw new data published at the American Society of Hematology meeting late last year.
Amgen said it is now pausing enrollment in the ongoing phase 1 ”while we discuss protocol modifications to optimize safety monitoring and mitigation with the FDA,” but it “expects to resume patient enrollment” in the coming months.
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Analysts at Jefferies said they believe this pause is due to “protocol modifications for safety mitigation (we think from cytokine release syndrome),” a common but potentially deadly side effect and one many companies have had to balance with efficacy from their immuno-oncology meds.
There’s a second pause for AMG 673, another half-life extended BiTE molecule targeting CD33, which is on a hiatus “while we gather further information on the CD33 program through progression of AMG 330.”
That drug is a bispecific antibody that works by targeting CD33, an antigen widely expressed on the surface of acute myeloid leukemia cells, and then using another antigen, CD3, on the surface of T cells, to enable the latter to target the former.
At the American Society of Clinical Oncology meeting last summer, Amgen presented phase 1 data from ‘330 in certain leukemias, but these disappointed some analysts with relatively low efficacy and high rates of cytokine release syndrome. A path forward for the drug could include different blood cancers and a combo approach.
Two other programs have been hit with stoppages: AMG 596, another BiTE molecule but one targeting EGFR variant III for glioblastoma, a deadly form of brain cancer, has been halted “as we prioritize our portfolio.”
And finally, a phase 1 test of its oral MCL-1 inhibitor AMG 397 was paused “with focus shifting to the intravenous MCL-1 inhibitor AMG 176,” which is currently in phase 1 for blood cancers.
Amgen, which reported sales for the year jumped 9% to $25.4 billion, saw its shares down 1.6% after-hours Tuesday.