AZ, Merck link to develop and commercialise cancer drugs

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor already approved for BRCA-mutated ovarian cancer in multiple lines of treatment and in development across several other tumour types.

The companies will develop and commercialise Lynparza jointly, both as monotherapy and in combination with other potential medicines. Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi (durvalumab) and Keytruda (pembrolizumab).

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

Pascal Soriot, AZ’ chief executive, said the collaboration "builds on scientific evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumours.

"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."

Under the terms of the deal, the firms will share development and commercialisation costs as well as gross profits from product sales. Merck will fund all costs of Keytruda in combination with Lynparza or selumetinib, while AZ will pay any costs relating to Imfinzi in combination with Lynparza or selumetinib.

Merck will pay AZ up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain license options and up to $6.15 billion contingent upon successful achievement of future regulatory and sales milestones.

Second-quarter results
News of the deal came alongside AZ’ financial results for the second quarter, which saw total revenues of $5.1 billion, marking a drop of 10 percent on the year-ago period or an 8 percent decline at constant exchange rates (CER).

The drop was in-line with expectations given the continued hit to sales from the loss of exclusivity of Crestor (rosuvastatin) and Seroquel XR (quetiapine) in the US.

Core operating profit hit $1.6 billion, up 10 percent (8 percent at CER), while core earnings per share grew 5 percent (6 percent at CER) to $0.87.

The firm re-iterated its financial guidance for the full year of a low to mid single-digit percentage decline for total revenues and low to mid teens percentage decline for EPS.

Imfinzi blow
In other news, AZ and its global biologics research and development arm MedImmune reported that initial results from a trial in stage IV lung cancer show that a combination of Imfinzi and tremelimumab failed to meet a secondary endpoint of improving progression-free survival (PFS) compared to standard of care.

The trial will continue to assess two additional primary endpoints of overall survival (OS) for Imfinzi monotherapy and OS for the Imfinzi plus tremelimumab combination. Final OS data from both primary endpoints are expected during the first half of 2018.

Sean Bohen, AZ’ chief medical officer and executive vice president, Global Medicines Development, said while the results 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."

Tagrisso success
In more positive news on the clinical front, the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful PFS benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

The firm said that on the back of the "strong" results it would now initiate discussions with global health authorities on the data and regulatory submissions.