New Tumour Drug27 Jul 2020 11:39
AstraZeneca PLC on Monday said it has entered into an oncology collaboration worth up to GBP6 billion with Daiichi Sankyo Co Ltd, as Astra also announced that Calquence and Imfinzi have been recommended for approval in the EU.
The FTSE 100 drug manufacturer said it has inked a global development and commercialisation agreement with Japanese peer Daiichi. The partnership will see both companies work on Daiichi Sankyo's proprietary trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate and potential new medicine for the treatment of multiple tumour types.
"DS-1062 is currently in development for the treatment of multiple tumours that commonly express the cell-surface glycoprotein TROP2. Among them, TROP2 is overexpressed in the majority of non-small cell lung cancers and breast cancers tumour types that have long been a strategic focus for AstraZeneca," the pharmaceutical firm said.
Astra and Daiichi will jointly develop and commercialise DS-1062 worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.
AstraZeneca will pay Daiichi Sankyo USD1 billion upfront in staged payments, with USD350 million due on completion, USD325 million after a year and USD325 million after two years. AstraZeneca will pay additional conditional amounts of up to USD1 billion for the successful achievement of regulatory approvals and up to USD4 billion for sales-related milestones.
"We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2. We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of Enhertu to further expand our pipeline and leadership in Oncology," said AstraZeneca Chief Executive Pascal Soriot.
Separately, Astra said its Imfinzi drug has been recommended for marketing authorisation in the EU for the first-line treatment of adults with extensive-stage small cell lung cancer.
It said the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency was based on results from the Phase III CASPIAN trial for Imfinzi plus chemotherapy which showed that the combined treatments reduced the risk of death by 27% compared with chemotherapy alone. Results also demonstrated that Imfinzi added to chemotherapy delayed the time it took for lung cancer-related symptoms to worsen.
Another Astra drug, Calquence, has been recommended for approval in the EU for the treatment of adult patients with chronic lymphocytic leukaemia. The positive opinion by the committee was based on results from two Phase III clinical trials, ELEVATE TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL.
In the ELEVATE TN trial, Calquence combined with obinutuzumab reduced the risk of disease progression or death by 90% and 80% respectively, compared to standard chemo-immunotherapy treatment chlorambucil plus obinut