Shares of MEI Pharma Inc. plunged more than 60% in trading on March 25 after the company announced that additional clinical research will be needed in order for the its phosphatidylinositol-3-kinase (PI3K) inhibitor zandelisib to be considered for regulatory approval.
Bristol Myers Squibb and Nektar Therapeutics released disappointing news about their joint Phase III PIVOT IO-001 study evaluating a dual therapy of the immunotherapy drug bempegaldesleukin in combination with Opdivo (nivolumab) compared with Opdivo alone to treat unresectable or metastatic melanoma.
Positive final results from the Phase III COSMIC-311 trial for Cabometyx (cabozantinib) were reported by Exelixis for patients diagnosed with previously treated radioactive iodine-refractory differentiated thyroid cancer.
The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.
Merck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) at the virtual 2021 Genitourinary Cancers Symposium of the company’s checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma.
A roundup of biopharma news and updates includes Merck and Eisai’s Keytruda-Lenvima combo hitting the mark in a Phase III study for advanced endometrial cancer.
Merck and Eisai announced new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).
AstraZeneca and Daiichi Sankyo’s Enhertu received supplemental Biologics License Application (sBLA) acceptance and U.S. priority review for the treatment of HER2-positive metastatic gastric cancer.
Amgen presented positive topline data from the Phase II CodebreaK 100 trial of sotorasib in KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC).
Bristol Myers Squibb announced that the Phase III IDHENTIFY trial of Idhifa (enasidenib) plus best supportive care compared to conventional care did not meet the primary endpoint of overall survival in relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation.