Merck & AstraZeneca entering strategic oncology collaboration

Following disappointing announcements this week concerning the unmet primary endpoints of their Phase III trials, Merck and AstraZeneca — under advice from experts of the life sciences team at law firm, Gowling WLG — have today revealed they are entering a strategic oncology collaboration.

The collaboration will involve the co-development and co-commercialisation of AstraZeneca’s Lynparza (olaparib) oral poly ADP ribose polymerase (PARP) inhibitor for multiple cancer types. Both companies will look to develop and commercialise this therapy as a monotherapy and in combination with other medicines jointly and then independently in combination with Imfinzi (durvalumab, PD-L1) — AstraZeneca — and KEYTRUDA (pembrolizumab, PD-1) — Merck.

Additionally, the companies will jointly develop and commercialise AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer.

“Our strategic collaboration builds on scientific evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumours,” said Pascal Soriot, chief executive officer of AstraZeneca. “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. This is a truly exciting step and we are pleased to work with Merck, a company that shares our passion for science to deliver new medicines for cancer patients.”

“This global collaboration between AstraZeneca and Merck, two oncology leaders, will increase the possibilities for patients to have more treatment options for more cancers,” added Kenneth C. Frazier, chief executive officer of Merck. “Merck continues to build its leadership in immuno-oncology with KEYTRUDA as foundational in monotherapy and combination therapy, and this collaboration expands our oncology leadership into the growing targeted therapies of PARP and MEK inhibitors. We look forward to working with AstraZeneca to create greater value for patients and shareholders than if both companies worked independently.”

On Monday Merck revealed that its PD-1 therapy (Keytruda) did not meet the pre-specified primary endpoint of overall survival (OS) in its Phase III KEYNOTE-040 trial investigating the therapy for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). However, the safety profile observed in the trial was consistent with that observed in previously reported studies of the therapy and the company has specified that the indication will remain unchanged and clinical trials will continue.

In a press release today, AstraZeneca announced that the combination of its PD-L1 therapy (Imfinzi) and tremelimumab did not meet the primary endpoint of improving progression-free survival (PFS) compared to standard-of-care (SoC) in its Phase III MYSTIC trial for previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC). “While the results from the MYSTIC trial for progression-free survival in first-line Stage IV non-small cell lung cancer compared with standard of care are disappointing, the trial was designed to assess overall survival and we look forward to evaluating the remaining primary endpoints of overall survival for both mono- and combination therapy,” emphasized Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca.