Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients.
As China becomes a major source of global clinical trial evidence, the retraction of a high-profile China-led lung cancer study is raising questions about whether journals, regulators and drug developers have adequate systems to validate fast-moving clinical claims.
As China becomes a major source of global clinical trial evidence, the retraction of a high-profile China-led lung cancer study is raising questions about whether journals, regulators and drug developers have adequate systems to validate fast-moving clinical claims.
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Missing statistical significance on the primary overall survival phase III endpoint with antibody-drug conjugate (ADC) sigvotatug vedotin compared with docetaxel in non-small-cell lung cancer (NSCLC), Pfizer Inc., which gained the candidate through its $43 billion buyout of Seagen Inc. in 2023, is forging ahead based on subgroup signals, phase I data and an ongoing phase III Keytruda combination effort currently underway.
Ahead of an approval bid with its own candidate in non-small-cell lung cancer, GSK plc is planting a stake in the space by way of the $10.6 billion buyout of Nuvalent Inc. for $124 per share, a 40% premium to Nuvalent’s last closing price and a 26% premium to the 30-calendar day amount. Net of cash acquired, GSK’s investment will total about $9.4 billion.
Tango Therapeutics Inc. will be sitting down with the U.S. FDA soon to discuss pivotal work ahead based on what Cantor analyst Eric Schmidt called “amazing” data from the phase I/II study of vopimetostat, a PRMT5 inhibitor, paired with Revolution Medicines Inc.’s RAS(ON) inhibitors in patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC) as well as non-small cell lung cancer.
At the recent meeting of the Society of Nuclear Medicine and Molecular Imaging, researchers from Actinium Pharmaceuticals Inc. presented preclinical efficacy data on ATNM-400 in models of non-small-cell lung cancer (NSCLC).
Multiple companies are chasing Akeso Inc. and Summit Therapeutics Inc. in the battle to potentially dethrone Keytruda (pembrolizumab, Merck & Co. Inc.) as the top cancer immunotherapy for patients with non-small-cell lung cancer with bispecific antibodies targeting PD-(L)1 and VEGF.
