- AstraZeneca's (AZ) investigational cancer drug, selumetinib, failed to meet primary endpoints of progression-free survival and overall survival in KRAS-mutation-positive non-small cell lung cancer (NSCLC) patients in a Phase 3 trial, known as SELECT-1.
- Selumetinib is an oral MEK1/2 inhibitor that AstraZeneca acquired from Array Pharma in 2003. The drug has been in development ever since in the context of a broad cancer program. The company had a lot of optimism about the potential for selumetinib's development in NSCLC based on the strength of Phase 2 results.
- AstraZeneca will continue development of selumetinib for thyroid cancer and neurofibromatosis.
Not long ago, AstraZeneca CEO Pascal Soriot pledged that the company would be generating $45 billion in annual income by 2023. Much of that anticipated increase--roughly $20 billion over current revenues---is expected to come from AstraZeneca's oncology division, including both its current portfolio and its pipeline of drugs.
AstraZeneca has been relatively successful in its development of selumetinib, and plans to continue to develop it in the context of other cancers. Nonetheless, the failure to successfully progress from Phase 2 to Phase 3 for this indication came as an unpleasant surpise to AstraZeneca.
The big pharma wasn't solely depending on selumetinib to flesh out its portfolio; the drug had failed in a previous trial of rare cancers, lowering expectations for the therapy.
Currently, the most promising candidates to help make good on Soriot's goal are Tagrisso, which is approved for treatment of T790M-mutation-positive NSCLC and Lynparza for ovarian cancer. Both are expected to be blockbusters. In addition, durvalumab is a promising pipeline drug with potential applications in lung and other cancers---and possibly the best way for AstraZeneca to muscle its way into the immunotherapy arena. Add to that acalabrutinib, a blood-cancer hopeful which AstraZeneca recently acquired from Acerta for $4 billion.