Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01.
Daiichi Sankyo Co Ltd.’s HER3-directed antibody-drug conjugate patritumab deruxtecan showed clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC) in the Herthena-Lung1 phase II trial.
Current standard of care treatment for non-small-cell lung cancer (NSCLC) tumors harboring mutations of the epidermal growth factor receptor (EGFR) gene includes a wide variety of tyrosine kinase inhibitors (TKIs). There are, however, some types of NSCLC tumors, such as the ones with EGFR exon 20 insertion mutations, that have a much-limited margin of therapeutic intervention. Researchers from Suzhou Puhe Pharmaceutical Technology Co. Ltd. have reported the identification and early evaluation of a small-molecule third-generation TKI of EGFR, YK-029A, being developed as an anticancer agent.
Roche Holding AG’s Genentech subsidiary has broken new ground with a victory in phase III testing of the oral, anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early stage, ALK-positive non-small-cell lung cancer (NSCLC). The drug, well known to doctors in the advanced setting, was compared with platinum-based chemotherapy and met its primary endpoint of disease-free survival at a prespecified interim analysis.
Epidermal growth factor receptor (EGFR) is involved in cell proliferation leading to malignant transformation, and for that it is considered a therapeutic target for treatment and prevention in lung and other cancers.
Tscan Therapeutics Inc. has received FDA clearance of its IND application for TSC-203-A0201, a T-cell receptor (TCR)-engineered T-cell therapy (TCR-T) targeting preferentially expressed antigen in melanoma (PRAME). PRAME is expressed in melanoma and other solid tumors, including head and neck cancers and non-small-cell lung cancers. TSC-203-A0201 is specific for patients with HLA type A*02:01.
The narrative of TIGIT-targeting immunotherapy development, beset by negative news in recent months, has found a positive plotline again, thanks to what Roche Holding AG referred to as “an inadvertent disclosure” of a second interim analysis from the phase III Skyscraper-01 study testing anti-TIGIT candidate tiragolumab with anti-PD-L1 antibody Tecentriq (atezolizumab) in non-small-cell lung cancer.
Thymidylate synthase (TS) is an enzyme essential for DNA synthesis and cell proliferation and is a potential oncoprotein itself. Consequently, TS is considered a molecular target for malignant tumors.
Novarock Biotherapeutics Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd., has received FDA approval of its IND application for NBL-028, a CLDN6-CD137 bispecific antibody.