Latest From Alaric DeArment
The announcement that LEAP-006 and LEAP-008, both in non-small cell lung cancer, did not meet their primary endpoints adds to a string of failures for the combination.
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.
The company blamed lack of funding for incomplete enrollment of the Phase II study in acute suicidal ideation and behavior in major depressive disorder, saying it would have reached statistical significance had it fully enrolled.
The Swiss drug maker’s decision to give back rights to tislelizumab means BeiGene goes without the potentially $1.55bn in milestone payments the companies had agreed to in early 2021.
Research shows bringing trials to community oncology centers remains a daunting task, but Verily and OneOncology aim to help with new clinical trial management software. In other trial news, MindBio’s LSD goes into Phase II; Erasca starts tumor agnostic program; the Project to Accelerate New Treatments for Tuberculosis launched an international study investigating new combinations; and more.
The US FDA approved the JAK inhibitor momelotinib for myelofibrosis with anemia, with an analyst forecasting peak sales of more than $425m.