The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Bad news for Amgen Inc. could mean upside for Mirati Therapeutics Inc., though the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) has yet to tell the tale regarding Lumakras (sotorasib), the former’s KRAS-G12C inhibitor.
Providing the right therapy at the right time has proven more difficult in the world of cancer than in other disease areas thanks to the variability in treatment response, but a new study hints that this problem may be at least partly solved for non-small cell lung cancer (NSCLC). A study presented at this year’s meeting of the American Society for Radiation Oncology (ASTRO) in San Diego shows that circulating tumor DNA (ctDNA) can provide therapeutic guidelines for oligometastatic forms of the disease, including when high-dose radiation therapy may or may not be indicated.
Ocean Biomedical Inc. has demonstrated the effectiveness of its anti-chitinase 3-like-1 (CHI3L1) antibody in suppressing and reversing tumor growth in studies of epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) cells.
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.
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.
