Amgen UK and Lab21 have announced a partnership to introduce a new genetic therapy test for advanced bowel cancer treatment in the UK
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.
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 percent of patients with advanced bowel cancer have wild type Kras.
Of these, up to 60 percent would be expected to respond to Vectibix.
Over 36,000 people in Britain develop bowel cancer every year and about 21,000 have metastatic cancer at any one time.
Berwyn Clarke, chief scientific officer at Lab21, said: "We are delighted to complete this partnership with Amgen, a global biotechnology leader.
"We are committed to providing a fully comprehensive service for cancer patients and believe that the Kras test is an important component".
"Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of cancer.
"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 more important.
"The successful conclusion of this agreement further demonstrates Lab21 as a recognised provider of top quality clinical diagnostic services to facilitate improved healthcare in Europe.
"We are especially pleased to secure this partnership and we hope to support Amgen with other clinical services in the future," Clarke said.
"We are very pleased to work with Lab21," said Charles Brigden, medical director of Amgen UK.
"We are proud that for the first time we will be able to treat advanced bowel cancer patients with a targeted agent based on a predictive biomarker.
"This is a big step forward towards individualised care in bowel cancer.
"We now know that Vectibix will only be effective 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".
"It is particularly useful that Vectibix is being launched with a screening test for Kras, which will help clinicians to target those patients, most likely to benefit," said Maurice Slevin, consultant medical oncologist at the London Oncology Clinic.
"This means that patients unlikely to benefit will not receive a treatment which could expose them to unnecessary side-effects.
"Targeting cancer treatments is critical for the future if society is going to afford the ever increasing cost of innovative drugs".
"This predictive test is an important advance," said Ian Beaumont, director of public affairs at the charity Bowel Cancer UK.
"Launching a new drug for advanced bowel cancer with a predictive screening test brings us closer to personalised care."
