Takeda Pharmaceutical Co. Ltd. said it will work with U.S. regulators on the market withdrawal of Exkivity (mobocertinib), only two years after the oral tyrosine kinase inhibitor gained the FDA’s accelerated approval for use in locally advanced or metastatic non-small-cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after chemotherapy.
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.
