The July 25 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) could impact the future development of immune checkpoint inhibitors, such as Astrazeneca plc’s Imfinzi, to treat patients with non-small-cell lung cancer (NSCLC) both before and after surgery. Although much of the discussion will focus on an sBLA for Imfinzi (durvalumab), the committee will be asked to vote on whether the FDA should require that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within-trial assessment of the contribution of the treatment phase to efficacy results.
Scisparc Ltd.’s Mitocarex Bio Ltd. venture has validated the potential significant involvement of its target SLC25 carrier protein, using non-small-cell lung cancer (NSCLC) cells with diverse genetic backgrounds. Mitocarex used genetic manipulations and 3D spheroid systems, mimicking the main features of human solid tumors, to demonstrate the discovery.
Zymeworks Inc. has received IND clearance from the FDA for ZW-191, the company’s novel folate receptor-α (FRα)-targeted topoisomerase I (TOPO1) inhibitor antibody-drug conjugate (ADC). Clinical development is set to begin this year, with filings to initiate studies outside the U.S. to be made in the second half of this year.
A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial.
CDR-Life Inc. has expanded its pipeline of novel T-cell engagers (TCE) with the addition of CDR-813 and CDR-505. CDR-813 is a highly potent and selective TCE candidate targeting tumors expressing PRAME (preferentially expressed antigen in melanoma) in HLA-A*02:01 patients.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Genfleet Therapeutics (Shanghai) Co. Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to advance GFH-375 (VS-7375) into a phase I/II study in patients with advanced solid tumors with KRAS G12D mutation.
A new approach against non-small-cell lung cancer (NSCLC) has combined immunotherapy with molecularly targeted therapy to activate the immune response and inhibit oncogenic pathways, which prevented tumor progression and eliminated cancer cells. Brigham and Women’s Hospital scientists have developed nanoparticles loaded with antibody conjugates that could deliver large amounts of treatment to the tumor tissue. This new strategy could improve the results of conventional immunotherapy in these patients and reduce toxicity of existing treatments.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
