Eli Lilly has racked up another late-stage pipeline disappointment, dropping lymphoma drug candidate enzastaurin from development after it failed a phase III trial.
The results of the PRELUDE study of enzastaurin to prevent relapse in patients with diffuse large B-cell lymphoma (DLBCL) who had previously been treated with chemotherapy alongside Roche’s Rituxan (rituximab) failed to show any significant difference between the drug and placebo on disease-free survival.
Lilly said it expected to take a charge of around $30m in its second-quarter results as a result of the decision to drop enzastaurin, which acts as a serine/threonine kinase inhibitor of the PKC beta and AKT pathways. The company had previously said it hoped to file for approval by year-end.
Enzastaurin’s failure is the latest in a series of setbacks for Lilly, with phase III disappointments for schizophrenia candidate pomaglumetad, Alimta (pemetrexed) in lung cancer, tabalumab for rheumatoid arthritis and Alzheimer’s candidate solanezumab. The latter remains in development but is still highly speculative and likely to be delayed for at least three years.
“We are disappointed in the results that we’re announcing today,” commented Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology.
“However, 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 added.
Lilly’s cancer portfolio is currently headed by ramucirumab as a monotherapy for second-line gastric cancer – which has already been submitted for approval in the US under a rolling Biologics License Application (BLA). Following behind is necitumumab, in phase III trials alongside gemcitabine and cisplatin for first-line treatment of squamous non-small cell lung cancer (NSCLC).
The company’s phase II portfolio features 16 programmes, including two c-Met-targetting drugs – LY2801653 and LY2875358 – for a range of cancer as well as anti-IGF-1 and IGF-2 antibody cixutumumab for NSCLC.