This is combined with a bunch of new features like privacy labels on the App Store, grouped notifications, new widgets, new system sounds, and much more. These changes reflect upon the Control Center, menu bar, dock, and even apps like Safari and Messages. The OS features a user interface redesign that implements new blurs to establish a visual hierarchy. It succeeded macOS Catalina and carries a version number of 11. MacOS Big Sur is the 17th major release of macOS and was released back in November last year. Original story (published on April 14, 2021) follows:
Pdf to keynote version 1.04 a trial#
Clinical trial information: NCT03517449.New updates are being added at the bottom of this story… Secondary endpoints include objective response rate, health-related quality of life, safety and tolerability, and pharmacokinetics. A final OS analysis will occur at 518 OS events, when the study will have 90% power to detect a HR of 0.75 with a 1-sided 0.0245 significance level. The PFS analysis will occur at the planned interim analysis (~363 OS events in MMR-proficient patients ~524 PFS events), and the study will have 99% power to detect a hazard ratio (HR) of 0.55 with a 1-sided 0.0005 significance level. The dual primary endpoints are progression-free survival (PFS per RECIST v1.1 by blinded independent central review) and overall survival (OS). TPC is either doxorubicin 60 mg/m ² by IV Q3W or paclitaxel 80 mg/m ² by 1-hour IV infusion weekly (3 weeks on/1 week off). Patients will be randomized first according to MMR status MMR-proficient patients will be further stratified by ECOG PS, geographic region, and prior history of pelvic radiation. ~780 patients (~120 MMR-deficient ~660 MMR-proficient) will be randomized to receive LEN 20 mg orally once daily and PEMBRO 200 mg intravenously (IV) every 3 weeks (Q3W) or TPC. Patients must have mismatch repair (MMR) status confirmed by central laboratory via immunohistochemistry on archived or fresh tumor biopsy. Patients must be aged ≥ 18 years, have advanced EC that progressed after 1 prior platinum-based therapy, have measurable disease per RECIST v1.1, and an Eastern Cooperative Oncology Group performance status ≤ 1. Methods: A multicenter, randomized, open-label, phase 3 study (KEYNOTE-775/E7080-G000-309 NCT03517449) will evaluate efficacy and safety of LEN + PEMBRO vs treatment of physician’s choice (TPC) in patients with advanced EC. activity and a manageable safety profile in advanced endometrial cancer (EC).
Preliminary analyses of a phase 1b/2 study of LEN + PEMBRO showed promising antitumor. Pembrolizumab (PEMBRO) is a monoclonal antibody targeting programmed cell death receptor 1 (PD-1).
Pdf to keynote version 1.04 a plus#
Similar to the global Study 309/KEYNOTE-775 results, this analysis suggested favorable efficacy and manageable safety with lenvatinib plus pembrolizumab after platinum-based chemotherapy in Japanese patients with advanced endometrial cancer and supports this combination as a new standard of care in this population.īackground: Lenvatinib (LEN) is a multikinase inhibitor of vascular endothelial growth factor receptors 1–3, fibroblast growth factor receptors 1–4, platelet-derived growth factor receptor α, RET, and KIT. AEs were manageable and led to discontinuation of one/both study drugs in 36.5% of patients in the lenvatinib plus pembrolizumab group versus 7.8% in the TPC group. Hazard ratios (HRs) for PFS with lenvatinib plus pembrolizumab versus TPC were 1.04 (95% CI, 0.63-1.73) in patients with pMMR and 0.81 (0.50-1.31) in all-comers. 104 patients were randomized in Japan (data cut-off, Octomedian follow-up, 11.8 months). Primary endpoints were PFS by blinded independent central review per RECIST version 1.1 and OS. Patients were randomized to oral lenvatinib 20 mg/day plus intravenous pembrolizumab 200 mg every 3 weeks (Q3W up to 35 cycles of pembrolizumab) or TPC (intravenous doxorubicin 60 mg/m2 Q3W or paclitaxel 80 mg/m2 QW ). We present results for the Japanese subset. Primary endpoints of superiority for lenvatinib plus pembrolizumab were met for progression-free survival (PFS) and overall survival (OS) in all-comers (ie, regardless of mismatch repair status) and patients with MMR proficiency (pMMR). Study 309/KEYNOTE-775 is a phase 3 open-label, randomized trial of lenvatinib plus pembrolizumab versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer with progression after platinum-based therapy.
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