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Adding Verzenio to hormone therapy reduced the risk of relapse by 25 percent, while the PALLAS study, testing another CDK4/6 inhibitor, failed.
Although the benefit seen in the CAVE study needs Phase III confirmation, the analysis showed that plasma ctDNA testing may help identify best responders.
The two companies will evaluate the efficacy of the combination in patients with ER-positive, HER2-negative, advanced breast cancer.
The open-label, multi-center trial will start enrolling patients in the third quarter to evaluate the safety of lasofoxifene combined with abemaciclib.
The work suggests mass spec can more accurately assess levels of immunotherapy targets like PD-L1 than conventional clinical approaches.
The agency based its decision on a trial showing that patients receiving the combo had a median PFS of 19.4 months versus 12.4 months for those on Tarceva.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
Results of the Phase II monarcHER study suggest that heavily pretreated HER2-positive breast cancer patients may be spared a chemotherapy-based regimen.
The randomized, 400-patient trial will compare selpercatinib to chemotherapy for first-line treatment of medullary thyroid cancer.
The company is enrolling up to 400 patients in its LIBRETTO-431 trial to evaluate survival and response to selpercatinib.