Novelos drops NSCLC drug development after disappointing PH III results

US biopharmaceutical firm Novelos Therapeutic says that primary and secondary endpoints were not met in its pivotal Phase III trial in advanced non-small cell lung cancer (NSCLC) with its lead product, NOV-002, in combination with first-line chemotherapy. Based on these results the company will discontinue development of NOV-002 for NSCLC in combination with first-line paclitaxel and carboplatin chemotherapy.

Adding NOV-002 to paclitaxel and carboplatin chemotherapy was not statistically or meaningfully different in terms of efficacy-related endpoints or recovery from chemotherapy toxicity versus chemotherapy alone. NOV-002 was safe, as it did not add to the overall toxicity of chemotherapy. Detailed trial results are expected to be presented at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) taking place June 4-8 in Chicago, Illinois.

'We designed and executed a robust Phase III NSCLC trial but, disappointingly, NOV-002 did not work in this very difficult to treat indication in combination with this chemotherapy,' said Harry Palmin, president and chief executive of Novelos.

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