Phase III trial comparing it to Roche's Avastin misses primary endpoint
Lilly's run of disappointing pipeline news continued late last week when it reported a phase III trial of Alimta in lung cancer failed to meet its objectives.
The POINTBREAK trial compared Alimta (pemetrexed) to paclitaxel given alongside a treatment regimen based on Roche's Avastin (bevacizumab) and carboplatin in patients with non-squamous, non-small cell lung cancer (NSCLC).
Alimta is already approved to treat NSCLC but Lilly was hoping to expand its label to include combination therapy of the cancer, which could have increased the size of the market for the drug.
Unfortunately, Lilly's drug was unable to meet its primary target of increasing overall survival compared to paclitaxel, despite strong data in an earlier phase II study, although it was able to show an increase in progression-free survival (PFS).
The disappointing results come after the pharma company was forced to halt development of late-stage schizophrenia drug candidate pomaglumetad methionil (mGlu2/3) after determining it was unlikely to be effective, as well as negative phase III trial results for its Alzheimer's drug candidate solanezumab.
The failures are particularly discomforting for Lilly as the company has generally shunned the large-scale merger approach of many of its peers in the pharma sector in favour of a traditional operating strategy with home-grown R&D and licensing at its core.
It also badly needs new products to come through the pipeline as it copes with the loss of patent protection for blockbuster brands. Zyprexa (olanzapine) for schizophrenia lost US patent protection last year, while antidepressant Cymbalta (duloxetine) and diabetes treatment Humalog (insulin lispro) will both face generic competition in 2013.
Lilly has been trying to expand uses of Alimta - another big seller with revenues of $1.27bn in the first six months of 2012 - from its current indications as a monotherapy in NSCLC and as a treatment for another lung cancer called malignant pleural mesothelioma.