AstraZeneca has entered into a global collaboration with US drugmaker Merck to develop and commercialize the former’s investigational cancer treatments Lynparza (olaparib) and selumetinib.

Lynparza is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor that is approved for BRCA-mutated ovarian cancer in multiple lines of treatment. The therapy has 14 indications currently being developed across several tumor types, including breast, prostate and pancreatic tumors.

The companies will develop and commercialize Lynparza jointly, both as monotherapy and in combination with other potential medicines. In addition, they will independently develop and commercialize Lynparza in combination with their respective PD-L1 and PD-1 medicines, namely AstraZeneca’s Imfinzi (durvalumab) and Merck’s Keytruda (pembrolizumab).

AstraZeneca and Merck will also jointly develop and commercialize selumetinib, an oral, potent, selective inhibitor of MEK, which is currently being developed for multiple indications including thyroid cancer.

Pascal Soriot, AstraZeneca’s CEO, said the partnership builds on scientific evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumors. He commented: “By bringing together the expertise of two leading oncology innovators, we will accelerate Lynparza’s potential to become the preferred backbone of many immuno-oncology combination therapies as the world’s first and leading PARP inhibitor.”

The companies will share the costs of development and commercialization as well as gross profits from product sales. Merck will fund all costs of Keytruda in combination with Lynparza or selumetinib, while AstraZeneca will pay costs relating to Imfinzi in combination with Lynparza or selumetinib.

Under the terms of the deal, Merck will pay AstraZeneca up to $8.5 billion in total, including $1.6 billion upfront, $750 million for certain license options and up to $6.15 billion dependent on achieving regulatory and sales milestones.

Separately, the Anglo-Swedish drugmaker has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Imfinzi for treating patients with locally advanced, unresectable non-small cell lung cancer, whose disease has not progressed following platinum-based chemoradiation therapy.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting.”

This latest designation for Imfinzi follows the accelerated approval granted by the FDA on May 1 this year for using the drug in previously treated patients with advanced bladder cancer.