Merck & Co has agreed to pay AstraZeneca up to $8.5 billion as part of a global deal to co-develop and co-commercialize the latter’s ovarian cancer drug Lynparza™ (olaparib) and late-stage investigational MAPK/ERK kinase 1/2 (MEK 1/2) inhibitor selumetinib for multiple cancer indications.

Under terms of the deal, AstraZeneca will receive  $1.6 billion upfront, $750 million in license options, and potentially another $6.15 million in regulatory and sales milestones.

AstraZeneca’s poly(ADP-ribose) polymerase (PARP) inhibitor Lynparza is currently in development for 14 potential indications in multiple tumor types, including breast, prostate, and pancreatic cancers. Merck and AstraZeneca said they will share the costs and future gross profits associated jointly developing and commercializing Lynparza and selumetinib monotherapies and of developing Lynparza as a combination therapy with drugs other than programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors.

Merck will separately develop and commercialize Lynparza in combination with its own PD-1 inhibitor Keytruda® (pembrolizumab) and will be responsible for funding the development and commercialization of  Keytruda with selumetinib. AstraZeneca will similarly develop Lynparza as combination therapy with its PD-L1 inhibitor Imfinzi™ (durvalumab) and will also be responsible for funding potential development of Imfinzi combined with selumetinib. Imfinzi won FDA accelerated approval in May for treating advanced or metastatic urothelial carcinoma in patients who have already received platinum-containing chemotherapy. 

Commenting on the deal, with Merck, Pascal Soriot, CEO at AstraZeneca, said, “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 tumors.” Kenneth C. Frazier, Merck CEO, added, “This global collaboration between AstraZeneca and Merck, two oncology leaders, will increase the possibilities for patients to have more treatment options for more cancers.”

Lynparza achieved sales of $216 million in 2016.  The drug was approved by the FDA in 2014 as monotherapy for germline BRCA-mutated advanced ovarian cancer in patients who have previously received three or more lines of chemotherapy. In the same year, the European Commission approved Lynparza as maintenance treatment for adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

Just last month, AstraZeneca reported positive data from the Phase III OlympiAD study evaluating Lynparza in patients with HER2-negative, BRCA-mutated metastatic breast cancer. A separate Phase III study, OLYMPIA, is ongoing in nonmetastatic breast cancer.

AstraZeneca licensed selumetinib from Array BioPharma in 2003. The MEK inhibitor is undergoing Phase III development for treating differentiated thyroid cancer, and is separately undergoing Phase II development in patients with pediatric neurofibromatosis type-1. Phase I trials are ongoing patients with solid tumors. In August 2016, AstraZeneca reported the failure of a Phase III study evaluating selumetinib combined with docetaxel chemotherapy in patients with KRAS-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Keytruda is approved for multiple cancer indications, but earlier this week Merck reported that the drug failed to meet its primary endpoint in the Phase III KEYNOTE-040 study in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The FDA had previously approved the drug for treating patients with recurrent or metastatic HNSCC whose disease had progressed on or after platinum-containing therapy. Merck said the KEYNOTE-040 results wouldn’t impact on the approved indication. 

Also this month, the FDA placed on hold three studies evaluating Keytruda in combination with other therapies for treating multiple myeloma, following reports of patient deaths.

AstraZeneca today separately reported the failure of Imfinzi monotherapy and combination therapy to meet one of its primary endpoints in the open-label Phase III MYSTIC study in lung cancer. The firm in parallel announced positive data from the Phase III FLAURA trial evaluating its established epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor lung cancer drug Tagrisso® (osimertinib) in previously untreated patients with locally advanced or metastatic EGFR mutation-positive NSCLC.

 








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