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 Ltd, 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 mutation1.
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 per cent of patients with advanced bowel cancer have wild type KRAS. Of these, up to 60 per cent would be expected to respond to Vectibix.2 Over 36,000 people in Britain develop bowel cancer every year and about 21,000 have metastatic cancer at any one time.
Dr 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.”