New cancer drug will be needing an ad agency

Steve’s breakdown: Amgen’s BiTE candidate AMG 420 shows positive action in early-stage blood cancer study but AMG 330 lags.

The company spends over $200 million/year and this one could add a chunk of change to that budget.

THOUSAND OAKS, CA: Initial data from two separate Phase 1 dose-escalation studies evaluating Amgen’s (NASDAQ:AMGN) BiTE immunotherapies AMG 420 and AMG 330 showed encouraging action for the former and not-so-encouraging action for the latter. The results were presented at ASH in San Diego.

Results from the study evaluating a range of doses of Fast Track-tagged AMG 420 in patients with relapsed/refractory multiple myeloma who had received at least two prior lines of treatment showed a 31% (n=13/42) response rate, including seven complete responders. The response rate in patients receiving 400 µg/d was 70% (n=7/10) with 86% (n=6/7) of the responders maintaining their responses for up to 7.5 months. One dose-limiting toxicity (peripheral polyneuropathy) was observed in the 400 µg/d arm which improved to baseline after IV immunoglobulin and corticosteroid treatment.

On the safety front, 48% (n=20/42) of treated patients experienced serious adverse events (AEs), including 17% (n=7/42) who required hospitalization (four prolonged). Treatment-related serious AEs included two cases of polyneuropathy and one case of edema. Cytokine release syndrome was observed in 16 patients, but only one case was serious. The 800 µg/d dose was determined to be intolerable. Two patients died during the study, neither related to treatment.

Results from the study assessing a range of doses of AMG 330 in patients with relapsed/refractory acute myeloid leukemia (AML) showed a complete response rate of 10% (n=4/40) at two doses (240 µg/d and 120 µg/d) but the complete responses were not sustained beyond one cycle of treatment. The majority of patients discontinued treatment due to cancer progression. Serious treatment-related adverse events were observed in 43% (n=17/40) of patients.

According to Amgen, a BiTE (Bispecific T cell engager) antibody construct can be engineered to target any tumor antigen expressed by any type of cancer.

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