Novartis drops late stage lung cancer candidate
pharmafile | November 11, 2010 | News story | Research and Development | ASA404, Antisoma, NSCLC, Novartis, cancer research, lung cancer, non small cell lung cancer, non-small cell lung cancer
Novartis has discontinued phase III trials for its lung cancer candidate ASA404 after it once again failed to meet its primary endpoint.
ASA404 was being tested in squamous and non-squamous non-small cell lung cancer (NSCLC) but failed to meet its primary endpoint of extending survival for the second line treatment of the disease.
The Switzerland-based pharma firm will incur charges of around $120 million as a result, which it will book in the fourth quarter.
Novartis said that resources earmarked for ASA4040, which had licensed from UK biotech Antisoma, would be “reallocated to other compounds in the oncology pipeline” in light of the candidate’s failure.
In March 2010, ASA404 failed to meet its primary endpoint in the ATTRACT-1 trial, which was evaluating it in combination with chemotherapy regimens paclitaxel and carboplatin as a first line treatment for advanced NSCLC.
Currently, AstraZeneca’s Iressa and Roche’s Tarceva are the main treatments for NSCLC.
Both act as angiogenesis inhibitors that stop the formation of new tumour blood vessels but can only be used successfully in around 15% of all NSCLC patients.
ASA404’s novel action was distinct from that of angiogenesis inhibitors. As a tumour-vascular disrupting agent (tumour-VDA), it works by selectively causing the collapse of existing tumour blood supply leading to apoptosis, or tumour cell death.
Failures for NSCLC candidates
In the past year there have been a number of late stage drugs failures in NSCLC, which is proving to be one of the more difficult disease areas to treat.
In June Bayer’s Nexavar failed in a late stage NSCLC trial NSCLC and Merck’s cancer vaccine was halted early due to safety concerns in March.
Meanwhile, in the same month Pfizer’s figitumumab failed in phase III studies and the FDA rejected Adventrx’s vinorelbine after the company failed to supply the regulatory body with enough data.
NSCLC accounts for around 80% of all lung cancers and it has one of the highest cancer mortality rates due to its proximity to the lymph nodes and the original growth point.
Ben Adams
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