AstraZeneca has announced a trio of developments regarding treatments for gastric and ovarian cancer as well as Crohn’s disease and ulcerative colitis.
The company reveals that, in conjunction with Merck, its potential blockbuster drug Lynparza has been approved in the US as a 1st-line maintenance treatment and alongside bevacizumab will be used to treat large numbers of patients with advanced ovarian cancer.
One in two women with advanced ovarian cancer has an HRD-positive tumour (homologous recombination deficiency).
For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.
Patients will be chosen for therapy based on an FDA-approved companion diagnostic test.
The approval by the US FDA was based on a biomarker subgroup analysis of the Phase III PAOLA-1 trial which showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67 per cent.
Dave Fredrickson, executive VP, Oncology Business Unit, said: “This approval represents another milestone for Lynparza in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease.
“These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.”
AstraZeneca, based at the science & technology hotspot at Cambridge Biomedical Campus, also announces a second US breakthrough therapy designation for Enhertu, a new medicine.
Along with Daiichi Sankyo Company, AstraZeneca says the approval is for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
Gastric cancer is the third leading cause of cancer mortality with a five-year survival rate of five per cent for metastatic disease.
José Baselga, executive VP, R & D Oncology, said: “Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines.
“We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease.”
AstraZeneca has also completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan.
AstraZeneca and Allergan have terminated their previous licence agreement and all rights to brazikumab have now returned to AstraZeneca.
Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab for Crohn’s disease (CD) and ulcerative colitis (UC), including the development of a companion diagnostic.
Pursuant to the 2012 collaboration between Amgen and AstraZeneca to jointly develop and commercialise a clinical-stage inflammation portfolio, including brazikumab, Amgen is entitled to receive a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched.
This includes the original inventor royalty. Other than this, AstraZeneca will own all rights and benefits arising from the medicine with no other payments due to Amgen or Allergan.
from Business Weekly https://ift.tt/2Lh3mNb