Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04563936.

Percolated Sulfide in Salt-Concentrated Polymer Matrices Extricating High-Voltage All-Solid-State Lithium-metal Batteries.

All-solid-state lithium-metal batteries (ASLMBs) are considered to be remarkably promising energy storage devices owing to their high safety and energy density. However, the limitations of current solid electrolytes in oxidation stability and ion transport properties have emerged as fundamental barriers in practical applications. Herein, a novel solid electrolyte is presented by in situ polymerization of salt-concentrated poly(ethylene glycol) diglycidyl ether (PEGDE) implanted with a three-dimensional porous L10 GeP2 S12 skeleton to mitigate these issues. The poly(PEGDE) endows more oxygen atoms to coordinate with Li+ , significantly lowering its highest occupied molecular orbital level. As a consequence, the electro-oxidation resistance of poly(PEGDE) exceeds 4.7 V versus Li+ /Li. Simultaneously, the three-dimensonal porous L10 GeP2 S12 skeleton provides a percolated pathway for rapid Li+ migration, ensuring a sufficient ionic conductivity of 7.7 × 10-4 S cm-1 at room temperature. As the bottlenecks are well solved, 4.5 V LiNi0.8 Mn0.1 Co0.1 O2 -based ASLMBs present fantastic cycle performance over 200 cycles with an average Coulombic efficiency exceeding 99.6% at room temperature.