A decade after obtaining the rights to the cancer drug selumetinib from Array Biopharma ($ARRY), the hungry pharma giant AstraZeneca ($AZN) is moving the MEK inhibitor into a late-stage study for non-small cell lung cancer. The move marks the opening of another front in AstraZeneca's offensive to rebuild a woefully inadequate late-stage pipeline.
Researchers decided to do a Phase III in NSCLC after tracking a significant response rate among Phase II patients who were KRAS-mutation positive. A 37.2% tumor response rate translated into a 3.2-month progression-free survival advantage in Phase II.
Under CEO Pascal Soriot, AstraZeneca has been spotlighting selumetinib as one of a small group of promising oncology drugs in its thin late-stage pipeline. Taking the campaign to ASCO last summer, the Big Pharma also highlighted olaparib, being repurposed in a late-stage study for ovarian cancer patients who share BRCA mutations, and moxetumomab pasudotox as a treatment for unresponsive or relapsed hairy cell leukemia patients. Investigators unveiled positive selumetinib data related to rare cases of eye melanoma.
"To our knowledge, SELECT-1 will be the first Phase III study to investigate whether a MEK inhibitor in combination with chemotherapy is superior to chemotherapy alone in KRAS-mutation positive advanced or metastatic non-small cell lung cancer," says Antoine Yver, vice president and head of oncology in AstraZeneca's Global Medicines Development unit. "This is an area of pressing clinical need, and our decision to progress selumetinib was based on Phase II results, which showed promising clinical activity in this group of patients."
- here's the press release