Three weeks after gaining US approval for Lymphoseek’s use in breast cancer and melanoma, Navidea Biopharmaceuticals is moving on to the next challenge. The Dublin, Ohio company might seek the FDA’s blessing for the lymph node tracer in head and neck cancer after reporting positive results from a phase III trial.
The company’s shares jumped 8% on the study results in early trading yesterday, reaching $2.75, though they declined slightly to close at $2.68. This is in marked contrast to investors’ reactions to the product’s approval, when a nasty case of selling on the news demolished Navidea’s share price by 22% over the course of two days (Navidea takes a kicking despite Lymphoseek approval, March 15, 2013). The shares had also increased ahead of that event in a classic example of bio-runup; Navidea must hope that yesterday’s rise does not presage another crash.
So positive were the data from the NEO3-06 trial that the study’s data safety monitoring committee recommended that it be halted early. The study is evaluating the ability of Lymphoseek, a radiolabelled compound that binds to CD206 receptors in lymph nodes, to identify sentinel nodes – those that primarily drain a tumour – in subjects with squamous cell carcinoma of the head or in the mouth.
Lymphoseek was used to pinpoint cancerous lymph nodes in 82 patients in the trial. The patients subsequently underwent multiple level nodal dissection surgery of the head and neck – the gold standard for this type of cancer – in which all their lymph nodes were removed.
Top-line data from an interim analysis showed that the imaging agent accurately identified 38 of 39 subjects with cancerous lymph nodes. The resulting false negative rate of 2.56% met the study’s primary endpoint.
Lymphoseek could enable far less invasive treatment. Navidea said that while multiple level nodal dissection led to removal of 38 lymph nodes per patient on average, Lymphoseek could have allowed the removal of an average of just four lymph nodes. And if treatment is less invasive, it is less expensive. While the FDA does not concern itself with the cost of therapies when considering their approvability, this bodes well for sales and could drive a share price increase.
The company says it will complete the full dataset and secondary analyses of NEO3-06 within the next few months, at which point a decision will be taken about whether to stop the trial and submit an sNDA. If it does, and the FDA decides favourably, Navidea’s share price would ordinarily be expected to rise – but given what happened last time this is hardly inevitable.