Please login to the form below

Not currently logged in
Email:
Password:

Biomarker analysis revives fortunes of Amgen's rilotumumab

Will launch phase III trial in patients with gastric cancer a year after halting development

Amgen - flag on building

Amgen says it is to launch a phase III trial of rilotumumab in patients with gastric cancer, a year after presenting lacklustre data from a mid-stage trial which looked likely to halt further development.

The rilotumumab (AMG 102) project has been rescued by a biomarker analysis of the earlier phase II data which found that the drug performed much better among patients with high levels of expression of a protein called MET.

MET is the receptor for hepatocyte growth factor/scatter factor (HGF/SF), the key driver of the molecular pathway targeted by rilotumumab.

Last year, Amgen reported that giving rilotumumab on top of chemotherapy provided a modest and non-significant improvement in progression-free survival in patents with locally advanced or metastatic gastric or gastroesophageal cancer, from 4.2 to 5.6 months, compared to chemotherapy given alone.

At the time the company said this profile was unlikely to support investment in a phase III programme of the drug, but that it would continue to analyse the data to see if a subgroup of patients could benefit from the drug.

The latest evaluation in MET-positive patients showed that rilotumumab was able to improve not only progression-free survival but also overall survival, extending the average life expectancy of patients from 5.7 months to more 11.1 months. MET-negative patients showed a trend towards shorter survival on Amgen's drug.

The results have led Amgen to plan a pivotal study to test the efficacy of rilotumumab in patients with advanced gastric and gastroesophageal cancer who also exhibit high MET expression.

Earlier this year, however, the company forged an alliance with Danish diagnostics specialist Dako A/S to develop and evaluate the use of a companion diagnostic for the development of rilotumumab.

Other HGF/SF inhibitors coming through the pipeline include AVEO Pharmaceuticals' ficlatuzumab (AV-299; in phase II) and Takeda/Millennium's TAK-701 (phase I).

Meanwhile, other companies have taken a slightly different tack, developing molecules which directly target the MET protein itself. xamples include Roche/Genentech's MetMab (onartuzumab), which is in phase III testing.

BiTE antibody shows promise in leukaemia
Meanwhile, Amgen has reported data from a phase II data trial of blinatumomab (AMG 103) which showed that the drug achieved a 72 per cent complete response rate in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

Blinatumomab is the first of a new class of agents called bi-specific T cell engagers or BiTE antibodies, which direct T cells to kill cancer cells. The lead investigator in the phase II study, Professor Max Topp, of the University of Wuerzburg in Germany, said the remission rate observed was a "vast improvement over the current standard of care".

Data from both the rilotumumab and blinatumomab studies are due to be presented at the American Society of Clinical Oncology meeting in Chicago next month.

21st May 2012

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Six Degrees Medical Consulting

Partnering with top global pharmaceutical companies, we push the boundaries to create meaningful, impactful and lasting learning opportunities. We leverage...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics