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.
SMARCA4-deficient cells have shown dependency on SMARCA2 for survival, suggesting SMARCA2 as a promising synthetic lethal target in SMARCA4-deficient cancers. Chinese researchers recently published data on a series of SMARCA2 PROTACs, among which compound [I] exerted good SMARCA2 degradation.
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell lung cancer (NSCLC).
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell lung cancer (NSCLC).
Shanghai Ailux Biotechnology Co. Ltd. and Ailux Inc. have presented preclinical data regarding the characterization of ALX-006, a 2+2 symmetric IgG1 PD‑1×VEGF bispecific antibody developed and designed for dual PD‑L1 and VEGF blockade as a cancer immunotherapeutic.