chronic lymphocytic leukemia

US-based biotechnology firm Gilead Sciences has released interim results of a single-arm, open-label Phase II study of its investigational oral inhibitor of spleen tyrosine kinase (Syk) GS-9973 for treatment of patients with relapsed or refractory haematologic malignancies.

The results demonstrate that 97% (n=28/29) of patients with chronic lymphocytic leukaemia (CLL) who were administered at least eight weeks of GS-9973 monotherapy experienced a reduction in lymph node size.

The primary endpoint of the ongoing trial is progression-free survival and the median age of the patients included in the safety analysis was 72 years.

Willamette Valley Cancer Institute and Research Center director of research Jeff Sharman said most patients with CLL eventually develop resistance to currently available therapies.

"This underscores the importance of identifying new treatments for patients with CLL," Sharman said.

"Response rates observed in this interim analysis support that GS-9973 has promising clinical activity in CLL to be further explored and developed."

"The B cell receptor signalling pathway is a novel area of focus for investigational therapies in CLL. GS-9973 targets the Syk protein, which initiates most signalling from the B cell receptor.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"Response rates observed in this interim analysis support that GS-9973 has promising clinical activity in CLL to be further explored and developed."

Out of the 29 CLL patients involved in the trial, 20 people (69%) achieved greater than 50% tumour shrinkage, including four of seven patients with a chromosome 17p deletion and/or a mutation in the TP53 gene, genetic abnormalities that have been linked to poor prognosis.

In the trial, the safety of GS-9973 was also evaluated in 78 patients with CLL or non-Hodgkin’s lymphoma (NHL) who had received at least four weeks of therapy.

According to the company, at the time of the data cut-off, 50 patients (64%) were continuing with GS-9973 treatment, with a median exposure of ten weeks.

Image: High-magnification micrograph of B-cell chronic lymphocytic leukemia. Photo: courtesy of Nephron.