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.
Having initiated its first two clinical trials in non-small-cell lung cancer since January, Nuvalent Inc. said it expects to unveil preliminary dose-escalation data before year-end. Ahead of the data, Nuvalent's phase I/II Arros-1 trial evaluating NVL-520, a kinase inhibitor, in patients with advanced ROS1-positive NSCLC and other solid tumors, continues to enroll participants.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.
Novartis AG’s attempt to repurpose its immunology drug canakinumab as an oncology therapy was always considered a long shot. Now, the chances of success have receded further after another phase III failure in lung cancer. The phase III Canopy-A study, which tested the drug as adjuvant treatment in adults with stages II-IIIA and IIIB completely resected non-small-cell lung cancer failed to meet its primary endpoint of disease-free survival vs. placebo.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.