Lilly takes $30m hit
pharmafile | May 13, 2013 | News story | Research and Development, Sales and Marketing | enzastaurin, lilly
Eli Lilly has taken a $30 million hit after abandoning late-stage development of its investigational cancer drug enzastaurin.
The compound was being tested in the Phase III PRELUDE study as a monotherapy to prevent relapse in patients with diffuse large B-cell lymphoma (DLBCL) – a sub-type of Non-Hodgkin’s lymphomas.
The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy.
“We are disappointed in the results that we’re announcing today,” admitted Richard Gaynor, Lilly Oncology’s vice president, product development and medical affairs.
Enzastaurin (LY317615 HCl) was an investigational oral small molecule, serine/threonine kinase inhibitor of the PKC beta and AKT pathways and had been in development for several years.
Patients in the PRELUDE programme had histologically confirmed DLBCL with an International Prognostic Index (IPI) – a tool used to predict survival outcomes – score of three to five at diagnosis.
They achieved a complete response or complete response-unconfirmed to cyclophosphamide, doxorubicin, vincristine, and prednisone, plus rituximab (R-CHOP) therapy, and were randomised 2:1 to receive enzastaurin or placebo.
Treatment continued until either the disease progressed, there were ‘unacceptable’ adverse events or patients completed three years of therapy.
Giving up on the drug is expected to result in a second-quarter R&D expense of approximately $30 million – although Lilly says this dent in the balance sheet will not impact on the company’s previously announced financial guidance for 2013.
Lilly plans to present data from the failed study at a future scientific meeting but there were no new safety findings, and the safety data were consistent with past results, the company insisted.
And Gaynor is putting a brave face on enzastaurin’s abandonment. “Our oncology pipeline is still one of the most robust across the industry, containing more than 20 molecules including two Phase III molecules in five different tumour types,” he said.
Adam Hill
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