Amgen Reports Serious Adverse Events in Cancer Treatment Trial

Amgen (AMGN) said Wednesday that an early-stage study of an investigational myeloma treatment showed serious adverse events.

The study of AMG 420 for relapsed and/or refractory multiple myeloma involved 42 patients who had experienced progression after at least two prior lines of treatment. They were given AMG 420 in varying doses up to 800 micrograms per day. The maximum tolerated dose turned out to be 400 micrograms, with an overall response rate of 70%.

Nineteen patients reported serious adverse events, with four requiring prolonged hospitalization. Serious adverse events related to treatment included grade 3 polyneuropathy in two patients and grade 3 edema in one. One patient also experienced grade 3 cytokine release syndrome. There were two deaths, but they were not considered treatment-related.

In another trial of the drug AMG 212 involving 16 patients with metastatic castration-resistant prostate cancer, decreases in prostate-specific antigen (PSA) levels amounted to at least 50% for three patients. One patient treated for 19.4 months at 80 micrograms/day recorded a complete regression of soft-tissue metastases and regression of bone metastases. One patient reported fatigue, a drug-related serious adverse event. Three patients reported cytokine release syndrome. Others experienced fever and chills.

Both AMG 420 and AMG 212 are investigational bispecific T-cell engager (BiTE) molecules under Amgen’s BiTE immuno-oncology platform.

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