Results from a phase III study comparing Celltrion Inc.’s biosimilar VEGF ligand inhibitor CT-P16 to Roche Holding AG’s Avastin (bevacizumab) in patients with metastatic or recurrent non-squamous non-small-cell lung cancer (NSCLC) found it to be similarly effective and as safe compared to the reference drug. Incheon, South Korea-based Celltrion presented the results at the 2022 annual meeting of the American Association for Cancer Research. The company now plans “to speed up the approval process through consultation with regulatory authorities in each country,” a Celltrion official said.
As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations.
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Shionogi & Co. Ltd.’s plan to make ensitrelvir, an oral antiviral for COVID-19, the first domestically approved COVID-19 treatment has hit a snag. Animal studies showed the drug, also known as S-217622, disturbed fetal development, according to media reports.
Oncology specialist Affimed NV is pushing forward with clinical development of technology that encourages natural killer cells to attack solid tumors. The move, supported by data the company presented at the annual meeting of the American Association for Cancer Research (AACR), is backing its creation of “innate cell engager” molecules.
In the summer of 2020, when Veru Inc. began researching sabizabulin for treating COVID-19 patients, the company’s CEO was cautioned that the virus could be gone by the time a therapy could be developed. Nearly two years later, Veru still has the compound in development and just reported phase III data that could propel it toward an emergency use authorization.
With 11 approved therapeutics in a diversity of targets and indications, antibody-drug conjugates (ADCs) have proved their clinical mettle. But they have not yet reached their full clinical potential, which, in the opinion of Astrazeneca plc’s Kenneth Thress, could transform patient care. The strength of ADCs, he told the audience at an educational session at the 2022 annual meeting of the American Association for Cancer Research (AACR 2022), is that it can turn anything into a targeted therapy.
Elevated serum creatinine levels in some participants prompted Biocryst Pharmaceuticals Inc. to pause three clinical trials involving BCX-9930, an oral, small-molecule factor D inhibitor for treating rare diseases.
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III.
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
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