Market preparation in acute myeloid leukemia
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Building perspective for a new standard of care
Acute myeloid leukemia (AML) is a rapidly progressing blood cancer characterized by uncontrolled proliferation of immature bone marrow cells. Physicians describe it as a monster that devours patients.
A harsh chemotherapy and stem cell transplant regimen first developed in 1973 remains the only available chance of cure, but this treatment is itself associated with high mortality rates.
Oncologists dread cases of AML that either do not respond to frontline therapy, or that relapse, because they have no viable options to offer. Patients rapidly succumb either to the illness or to the toxic effects of the medicines used to treat it.
Ironically, complete remission (CR) is achieved fairly often in AML therapy, but at the cost of high treatment-related mortality. In addition to raising awareness that a new drug was coming, we needed to prompt a more discerning consideration of the value of a CR—that not all remission was the same.
This CR-bridge ad illustrated how patients might be helped over a sea of uncontrolled leukemic cells to better survival prospects by achieving a solid but less toxic CR at the induction phase of treatment, before undergoing transplant.
Proposals were crafted to counter physician fatalism
Research had uncovered that many physicians, conditioned to failure and seeking to act with compassion, were loathe to treat relapsed AML too aggressively. One of the proposed launch ads conveyed a concept designed to challenge that paradigm, extending the possibility that a cure could still be achieved. Using a well known phrase from the famous Dylan Thomas poem that rages against death, the headline cleverly weaves the determined patient’s desire to fight on against his condition into the dialogue, creating a powerful and emotive call-to-action amongst treating physicians. While the harsh nocturnal landscape evokes the difficulties of the disease and its treatment, the archetype of a life-giving fire holds out a powerful offer of hope for prolonged survival.
The brand concept that physicians liked best showed the molcule swooping in to attack the leukemic cell. This image supported the copy's promise of restoring the physician's power to respond to relapsed disease, and achieve a CR without the devastating all-cause mortality of earlier treatments, thus helping to preserve their patient’s performance status.
Sadly, despite generating the most favorable Kaplan-Meier survival curves in 40 years, the Phase 3 trial failed to prove significance and the FDA declined approval—a deep tragedy for the AML community who remain without viable options to treat relapsed or refractory AML. However, the concept above also tested off the charts in 5 EU countries, where regulatory approval is still being sought.