Amgen and Lab21 in partnership agreement for new cancer therapy test
To introduce genetic therapy test for advanced bowel cancer treatment in the UK
Amgen UK and diagnostics company Lab21 have entered into a partnership to introduce a new genetic therapy test for advanced bowel cancer treatment in the UK.
Under the terms of the agreement, Lab21 will provide a screening test to indicate which patients are likely to benefit from Amgen's new drug for advanced bowel cancer Vectibix (panitumumab). It is the first time that the European Commission has licensed a bowel cancer product with the stipulation that a predictive test should be carried out.
The Lab 21 test was developed by DxS, a developer of biomarker assays and companion diagnostics for targeted cancer therapies.
Introduced to the UK earlier this year, Vectibix is currently licensed for patients with metastatic bowel cancer for whom standard chemotherapy has failed in patients with a specific gene mutation.1 In a biomarker analysis of the pivotal clinical trial, the drug doubled median progression-free survival in patients with non-mutated (wild type) KRAS (Kirsten Rat Sarcoma 2 viral oncogene homologue) compared with patients receiving best supportive care alone.
Amgen scientists had discovered that only those patients with the non-mutated (wild type) KRAS would respond to Vectibix. Patients with metastatic bowel cancer will be tested for the presence of the wild type KRAS gene before they are prescribed the drug. Approximately 60% of patients with advanced bowel cancer have wild type KRAS. Of these, up to 60% would be expected to respond to Vectibix.2
"Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of cancer," said Dr Berwyn Clarke, chief scientific officer at Lab21. "As new technologies develop to assist in cost-effective and efficient use of drugs, the need for prospective analysis of patient samples in high quality reference laboratories will become increasingly important."
"This is a big step forward towards individualised care in bowel cancer," said Dr Charles Brigden, medical director of Amgen UK. "We now know that Vectibix will be effective only in those patients whose cancers are positive for non-mutated (wild type) KRAS. Conversely, it also means that we can exclude those patients in whom the agent will not be beneficial."
In a separate move, Lab21 has acquired NPTech, an independent clinical laboratory company providing diagnostic testing services for the NHS and private healthcare providers in the UK and parts of Europe.
The acquisition significantly broadens Lab21's range of diagnostic tests, adding food intolerance testing; chemical and mould sensitivity testing; blood tests for a range of conditions; basic clinical chemistry; and salivary hormone testing. Lab21 now has the ability to test for intolerances to more than 100 food products and 50 chemicals including food colourings, antibiotics, anti-inflammatories and environmental chemicals.
In addition, NPTech has multiple other diagnostic tests for a variety of clinical disorders including salivary tests for adrenal hormones, sex hormones and sleep disturbance together with a range of clinical biochemistry blood testing, particularly in the area of thyroid disease diagnosis and management.
Ron Turner, who founded NPTech in 2002, will become laboratory director at Lab21.
