AstraZeneca:
a nail in the coffin of EGFr inhibitor hopes
AstraZeneca
has released results showing that a combination of its EGFr inhibitor
Iressa and platinum chemotherapy works no better than platinum alone in
non-small cell lung cancer. The news is a setback, but there was already
doubt over the EGFr inhibitor class's potential; investment bank forecasts
for Iressa sales were far too high. The prospects for Iressa and its peers
now look bleaker still.
Pharma
giant AstraZeneca has released phase III trial results from its cancer
drug, Iressa. They show that, in chemotherapy-refractory patients with
non-small cell lung cancer, an Iressa/platinum combination has no impact
on survival rates over existing platinum-based regimens.
The
news came as a surprise to some, as the epidermal growth factor (EGF)
receptor inhibitor had done well in phase II trials as a combination
therapy - and in phase III trials as a monotherapy. AstraZeneca's share
price fell 12%.
Iressa's
results demonstrate the dangers of over-hyping a drug that has not
demonstrated its efficacy. AstraZeneca emphasizes the potential strengths
of pipeline drugs, in an effort to boost awareness and achieve strong
initial sales - but no drug's clinical success is guaranteed ahead of
phase III results.
And
there were already alarm bells ringing over EGFr inhibitors, with BMS and
ImClone's Erbitux a key example. It was hailed as a wonder drug, but the
FDA refused to approve it based on current trial results.
Industry
analysts had forecast peak annual sales of $2 billion for Iressa, with
around two thirds of this coming from lung cancer. They were too high:
Datamonitor's forecast (produced before the latest results) was that even
if Iressa's results went to plan, its peak sales for NSCLC would be just
$630 million in 2008.
Given
the latest results, even this looks unlikely. While the drug is already
approved in Japan for monotherapy use, the latest news will not encourage
physicians to prescribe it. Nor will it help the drug's FDA panel hearing
for monotherapy use, due on September 24: the agency is now certain to
scrutinize that trial data with a fine toothcomb.
Overall,
if the FDA rejects Iressa as a monotherapy, this will be a disaster for
AstraZeneca; if it is approved, the poor combination results could still
hit perceptions and sales.
Related
research: Datamonitor, "Drugs of Tomorrow 2002: Lung Cancer"
(DMHC1734)
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