Biomea Fusion Inc. has received IND clearance from the FDA to begin a phase I/Ib trial of BMF-219, a selective, covalent menin inhibitor in patients with unresectable, locally advanced, or metastatic non-small-cell lung cancer (NSCLC), colorectal cancer, or pancreatic ductal adenocarcinoma with an activating KRAS mutation.
Lyell Immunopharma Inc. has received FDA clearance for its IND application to initiate a phase I trial for LYL-845, an investigational tumor-infiltrating lymphocyte (TIL) therapy enhanced with Lyell's Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.
Blueprint Medicines Corp. has divulged new EGFR mutant inhibitors, particularly EGFR L858R mutant and EGFR del746-750 mutant, reported to be useful for the treatment of non-small-cell lung cancer.
Sengine Precision Medicine Inc. is conducting a study utilizing its high-throughput patient-derived organoid drug screening technology to identify novel therapeutic targets in progressive anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC).
Researchers from Queensland University of Technology and Princess Alexandra Hospital in Australia have shown nucleic acid binding protein 2 (hSSB1), a DNA repair protein, to have prognostic significance for non-small-cell lung cancer (NSCLC). In an analysis of hSSB1 mRNA levels in NSCLC in online databases, higher levels were associated with poor prognosis.
Although it wasn’t a shutout, Spectrum Pharmaceuticals Inc. didn’t get the support it needed from a U.S. FDA advisory committee Sept. 22 for its non-small-cell lung cancer candidate, poziotinib, which it has proposed marketing as Pozenveo.
The fate of three cancer drugs, and possibly the future financial health of their sponsors, could be on the line Sept. 22 and 23 as the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) takes a hard look at the safety-efficacy data for Spectrum Pharmaceuticals Inc.’s Pozenveo, Oncopeptides AB’s Pepaxto and Secura Bio Inc.’s Copiktra. First up in the triple-header is Pozenveo (poziotinib), which is seeking accelerated approval as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations confirmed by an FDA-approved test.
Lift Biosciences Ltd. has shown that its first-in-class cell therapy destroyed on average over 90% of the tumoroid in a PDX (patient-derived xenograft) organoid across five solid tumor types, including bladder cancer, rectal cancer, colorectal cancer, gastric cancer and squamous cell non-small-cell lung cancer (NSCLC).
Spectrum Pharmaceuticals Inc. celebrated a long-awaited win with the U.S. FDA’s approval late Sept. 9 of novel G-CSF drug eflapegrastim, cleared for use in chemotherapy-induced neutropenia nearly four years after the company first filed for regulatory approval. Despite moves this year to reduce its cash burn, Spectrum has ready to go a commercial team expected to sell eflapegrastim as well as cancer drug poziotinib, which is under FDA review with a PDUFA date of Nov. 24, 2022.
It’s another setback for Jounce Therapeutics Inc. Top-line data from the phase II Select study of vopratelimab, the company’s lead candidate, combined with pimivalimab vs. pimivalimab alone in 69 patients missed its primary endpoint of mean tumor change when averaged over nine and 18 weeks. The clinical trial participants were immunotherapy naïve, immunotherapy TISvopra biomarker-selected, second-line non-small-cell lung cancer (NSCLC) patients.
