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Bavencio Intravenous 200 mg Special Drug Use results Survey (Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma) - Bavencio Special Drug Use-results Survey (urothelial carcinoma)

开始日期2021-02-24

申办/合作机构

Merck Biopharma Co., Ltd.

JPRN-JapicCTI-205458 / Recruiting临床1期

Safety Study of Bintrafusp alfa in Combination with Other Anti-cancer Therapies in Participants with Locally Advanced or Advanced Cervical Cancer

开始日期2020-10-19

申办/合作机构

Merck Biopharma Co., Ltd.

JPRN-jRCT2080225362 / Completed临床1期

Safety Study of Bintrafusp alfa in Combination with Other Anti-cancer Therapies in Participants with Locally Advanced or Advanced Cervical Cancer

开始日期2020-10-19

申办/合作机构

Merck Biopharma Co., Ltd.

100 项与 Merck Biopharma Co., Ltd. 相关的临床结果

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0 项与 Merck Biopharma Co., Ltd. 相关的专利（医药）

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项与 Merck Biopharma Co., Ltd. 相关的文献（医药）

2024-06-01·Clinical Pharmacology & Therapeutics

Asia‐Inclusive Global Development of Enpatoran: Results of an Ethno‐Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial

Article

作者: Goteti, Kosalaram ; Dong, Jennifer ; Gopalakrishnan, Sathej ; Fluck, Markus ; Venkatakrishnan, Karthik ; Krebs-Brown, Axel ; Nogueira Filho, Marco ; Shaw, Jamie ; Gradhand, Ulrike ; Klopp-Schulze, Lena ; Kuroki, Yoshihiro ; Lu, Hong ; Yalkinoglu, Özkan

Enpatoran is a novel, highly selective, and potent dual toll‐like receptor (TLR)7 and TLR8 inhibitor currently under development for the treatment of autoimmune disorders including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and myositis. The ongoing phase II study (WILLOW; NCT05162586) is evaluating enpatoran for 24 weeks in patients with active SLE or CLE and is currently recruiting. To support development of WILLOW as an Asia‐inclusive multiregional clinical trial (MRCT) according to International Conference on Harmonisation E5 and E17 principles, we have evaluated ethnic sensitivity to enpatoran based on clinical pharmacokinetic (PK), pharmacodynamic (PD), and safety data from an ethno‐bridging study (NCT04880213), supplemented by relevant quantitative PK, PD, and disease trajectory modeling (DTM) results, and drug metabolism/disease knowledge. A single‐center, open‐label, sequential dose group study in White and Japanese subjects matched by body weight, height, and sex demonstrated comparable PK and PD properties for enpatoran in Asian vs. non‐Asian (White and other) subjects across single 100, 200, and 300 mg orally administered doses. DTM suggested no significant differences in SLE disease trajectory for Asian vs. non‐Asian individuals. Aldehyde oxidase (AOX) is considered to be a key contributor to enpatoran metabolism, and a literature review indicated no relevant ethnic differences in AOX function based on in vitro and clinical PK data from marketed drugs metabolized by AOX, supporting the conclusion of low ethnic sensitivity for enpatoran. Taken together, the inclusion of Asian patients in MRCTs including WILLOW was informed based on a Totality of Evidence approach.

2024-03-01·Journal for ImmunoTherapy of Cancer

Efficacy, safety, and biomarker analyses of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with advanced non-small cell lung cancer

Article

作者: Agajanian, Richy ; Weisman, Andrew ; Marté, Jennifer L ; Abdul Sater, Houssein ; Rahma, Osama ; Bailey, Shania ; Vugmeyster, Yulia ; Lassoued, Wiem ; Ito, Rena ; Donahue, Renee N ; Tsai, Yo-Ting ; Machl, Andreas ; Walter-Rodriguez, Beatriz ; Schlom, Jeffrey ; Gulley, James L ; Lamping, Elizabeth ; Rajan, Arun ; Sato, Masashi

BackgroundBintrafusp alfa, a first-in-class bifunctional fusion protein targeting transforming growth factor-β (TGF-β) and programmed cell death ligand 1, has demonstrated encouraging efficacy as second-line treatment in patients with non-small cell lung cancer (NSCLC) in a dose expansion cohort of the phase 1, open-label clinical trial (NCT02517398). Here, we report the safety, efficacy, and biomarker analysis of bintrafusp alfa in a second expansion cohort of the same trial (biomarker cohort).MethodsPatients with stage IIIb/IV NSCLC who were either immune checkpoint inhibitor (ICI)-naïve (n=18) or ICI-experienced (n=23) were enrolled. The primary endpoint was the best overall response. Paired biopsies (n=9/41) and peripheral blood (n=14/41) pretreatment and on-treatment were studied to determine the immunological effects of treatment and for associations with clinical activity.ResultsPer independent review committee assessment, objective responses were observed in the ICI-naïve group (overall response rate, 27.8%). No new or unexpected safety signals were identified. Circulating TGF-β levels were reduced (>97%; p<0.001) 2 weeks after initiation of treatment with bintrafusp alfa and remained reduced up to 12 weeks. Increases in lymphocytes and tumor-associated macrophages (TAMs) were observed in on-treatment biospies, with an increase in the M2 (tumor trophic TAMs)/M1 (inflammatory TAMs) ratio associated with poor outcomes. Specific peripheral immune analytes at baseline and early changes after treatment were associated with clinical response.ConclusionsBintrafusp alfa was observed to have modest clinical activity and manageable safety, and was associated with notable immunologic changes involving modulation of the tumor immune microenvironment in patients with advanced NSCLC.

2024-02-01·Journal of Thoracic Oncology

Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study

Article

作者: Reck, Martin ; Cheng, Ying ; Baz, David Vicente ; Cil, Timucin ; Garon, Edward B ; Audhuy, Francois ; Felip, Enriqueta ; Martin, Claudio Marcelo ; Mornex, Francoise ; Fang, Jian ; Sato, Masashi ; Eggleton, S Peter ; Sezer, Ahmet ; Ito, Rena ; Vokes, Everett E ; Paz-Ares, Luis ; Barlesi, Fabrice ; Robinson, Clifford G ; Ahn, Myung-Ju ; Adjei, Alex A

INTRODUCTIONPreclinical evaluation of bintrafusp alfa (BA) combined with radiotherapy revealed greater antitumor effects than BA or radiotherapy alone. In a phase 1 study, BA exhibited encouraging clinical activity in patients with stage IIIB or IV NSCLC who had received previous treatment.METHODSThis multicenter, double-blind, controlled phase 2 study (NCT03840902) evaluated the safety and efficacy of BA with concurrent chemoradiotherapy (cCRT) followed by BA (BA group) versus placebo with cCRT followed by durvalumab (durvalumab group) in patients with unresectable stage III NSCLC. The primary end point was progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the investigator. On the basis of the recommendation of an independent data monitoring committee, the study was discontinued before the maturity of overall survival data (secondary end point).RESULTSA total of 153 patients were randomized to either BA (n = 75) or durvalumab groups (n = 78). The median progression-free survival was 12.8 months versus 14.6 months (stratified hazard ratio = 1.48 [95% confidence interval: 0.69-3.17]), in the BA and durvalumab groups, respectively. Trends for overall response rate (29.3% versus 32.1%) and disease control rate (66.7% versus 70.5%) were similar between the two groups. Any-grade treatment-emergent adverse events occurred in 94.6% versus 96.1% of patients in the BA versus durvalumab groups, respectively. Bleeding events in the BA group were mostly grade 1 (21.6%) or 2 (9.5%).CONCLUSIONSBA with cCRT followed by BA exhibited no efficacy benefit over placebo with cCRT followed by durvalumab in patients with stage III unresectable NSCLC.

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