[Translation] A Phase II, double-blind, dose-ranging, parallel-group, long-term extension study to evaluate the safety and efficacy of Enpatoran in subjects with subacute cutaneous lupus erythematosus, discoid lupus erythematosus, and/or systemic lupus erythematosus who have completed study treatment in WILLOW (MS200569_0003)

主要目的：评价enpatoran在SCLE、DLE和/或SLE受试者中的长期安全性和耐受性。次要目的：评价enpatoran在SCLE、DLE和/或SLE受试者中的长期安全性和耐受性及疾病控制方面的长期有效性；第三/探索性目的：评价enpatoran在SCLE、DLE和/或SLE受试者中的疾病控制方面的长期有效性；评价enpatoran在SLE受试者中的疾病控制方面的长期有效性；评价enpatoran在SCLE、DLE和/或SLE受试者中对患者报告的症状和功能状态方面的长期有效性；评价enpatoran在活动性SLE受试者中对患者报告的症状和功能状态方面的长期有效性；研究活动性SLE受试者中，Enpatoran对生物标志物的影响；研究Enpatoran对免疫细胞亚群和免疫球蛋白的影响；研究Enpatoran对PD生物标志物的影响；通过稀疏PK采样采集enpatoran血浆浓度数据；评价enpatoran对疫苗免疫状态的长期影响。评价Enpatoran对比安慰剂对活动性狼疮皮疹受试者红斑的影响。

[Translation]

Primary objective: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE. Secondary objectives: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE and the long-term effectiveness of enpatoran in disease control; Tertiary/exploratory objectives: To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SCLE, DLE and/or SLE; To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SLE; To evaluate the long-term effectiveness of enpatoran in patient-reported symptoms and functional status in subjects with SCLE, DLE and/or SLE; To evaluate the long-term effectiveness of enpatoran in patient-reported symptoms and functional status in subjects with active SLE; To study the effects of enpatoran on biomarkers in subjects with active SLE; To study the effects of enpatoran on immune cell subsets and immunoglobulins; To study the effects of enpatoran on PD biomarkers; To collect enpatoran plasma concentration data by sparse PK sampling; To evaluate the long-term effects of enpatoran on vaccine immune status. To evaluate the effects of Enpatoran versus placebo on erythema in subjects with active lupus rash.

Start Date16 Mar 2023

Sponsor / Collaborator

R-Pharm Germany GmbHStartup

[+3]

CTR20222665 / Active, not recruitingPhase 1

一项在转移性或局部晚期不可切除实体瘤受试者中评价M1774的安全性、耐受性和药代动力学/药效学特征的开放、多中心试验

[Translation] An open-label, multicenter trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamic profile of M1774 in subjects with metastatic or locally advanced unresectable solid tumors

主要目的：确认M1774在A1部分建立的全球RDE在中国实体瘤受试者中的安全性和耐受性。如果无法在中国实体瘤受试者中确认全球RDE，则确定当地RDE。次要目的：研究M1774单药治疗的PK特征。第三/探索目的：研究暴露量与QTc间关系。确定可预测M1774 PK特征、安全性和/或有效性差异的种系遗传多态性。评价M1774治疗实体瘤受试者的临床有效性。

[Translation]

Primary objective: To confirm the safety and tolerability of M1774 in Chinese subjects with solid tumors based on the global RDE established in Part A1. To determine the local RDE if the global RDE cannot be confirmed in Chinese subjects with solid tumors. Secondary objective: To investigate the PK characteristics of M1774 monotherapy. Tertiary/exploratory objective: To investigate the relationship between exposure and QTc. To identify germline genetic polymorphisms that may predict differences in the PK characteristics, safety, and/or efficacy of M1774. To evaluate the clinical effectiveness of M1774 in treating subjects with solid tumors.

Start Date05 Jan 2023

Sponsor / Collaborator

Aptuit (Verona) Srl

[+3]

CTR20222569 / TerminatedPhase 3

一项在具有高复发风险且不适宜高剂量顺铂的已手术切除的头颈部鳞状细胞癌受试者中评估xevinapant和放疗与安慰剂和放疗相比的有效性和安全性并证明无病生存期改善的随机、双盲、安慰剂对照、双臂III期研究

[Translation] A randomized, double-blind, placebo-controlled, two-arm Phase III study to evaluate the efficacy and safety of xevinapant and radiation therapy compared with placebo and radiation therapy and demonstrate improvement in disease-free survival in subjects with surgically resected head and neck squamous cell carcinoma who are at high risk of recurrence and are not candidates for high-dose cisplatin

本研究的目的是，证明xevinapant当添加到放疗方案时在不适宜接受以顺铂为基础的放化疗同步治疗的患有已手术切除的LA SCCHN的高风险受试者中的有效性优于安慰剂。

[Translation]

The objective of this study was to demonstrate the efficacy of xevinapant over placebo when added to a radiotherapy regimen in high-risk subjects with surgically resected LA SCCHN who were ineligible for concurrent cisplatin-based chemoradiotherapy.

Start Date06 Oct 2022

Sponsor / Collaborator

Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

100 Clinical Results associated with Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

0 Patents (Medical) associated with Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

Literatures (Medical) associated with Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

01 Feb 2023·JTO clinical and research reports

Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC

Article

Author: Andric, Zoran ; Losonczy, Gyorgy ; Ponce Aix, Santiago ; Gálffy, Gabriella ; Felip, Enriqueta ; Aguilar Hernández, Andrés ; Szalai, Zsuzsanna ; Vicente Baz, David ; Stojanovic, Goran ; Cobo Dols, Manuel ; Petrovic, Marina ; Duecker, Klaus ; Bernabe, Reyes ; Szima, Barna ; Zhou, Dongli ; Calles Blanco, Antonio ; García Ledo, Gema ; Juan-Vidal, Oscar ; Schroeder, Andreas ; Ciardiello, Fortunato ; Guezel, Guelseren

Introduction:

We present the results of a phase 2a trial of first-line avelumab (anti-programmed death-ligand 1 antibody) plus cetuximab (anti-EGFR antibody) in patients with advanced squamous NSCLC.

Methods:

Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m² (d 1) and 500 mg/m² (d 8), cisplatin 75 mg/m² (d 1), and gemcitabine 1250 mg/m² (d 1 and 8) for four 3-week cycles, followed by avelumab 800 mg and cetuximab 500 mg/m² every 2 weeks. The primary end point was the best overall response; the secondary end points were progression-free survival, duration of response, overall survival, and safety. Efficacy analyses were reported from an updated data cutoff.

Results:

A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%-50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2-12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event.

Conclusions:

The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155).

01 Oct 2021·Journal for immunotherapy of cancerQ2 · MEDICINE

Avelumab for platinum-ineligible/refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck: phase Ib results from the JAVELIN Solid Tumor trial

Q2 · MEDICINE

ArticleOA

Author: Guigay, Joël ; Patel, Manish R ; Bajars, Marcis ; Balmanoukian, Ani ; Gordon, Michael S ; Le Tourneau, Christophe ; Zhou, Dongli ; Keilholz, Ulrich ; Grote, Hans Juergen ; Penel, Nicolas ; Daste, Amaury ; Mita, Alain ; Lee, Keun-Wook ; Vansteene, Damien ; Wong, Deborah J ; Schöffski, Patrick ; Goel, Sanjay ; Gutierrez, Martin

Background:

Recurrent and/or metastatic (R/M) disease develops in approximately 65% of patients with squamous cell carcinoma of the head and neck (SCCHN) and is associated with a poor prognosis. Immune checkpoint inhibitors have proven effective in multiple tumor types, including R/M SCCHN. We report the efficacy and safety of avelumab (antiprogrammed death ligand 1 antibody) in an expansion cohort of patients with platinum-refractory/ineligible R/M SCCHN enrolled in the phase I JAVELIN Solid Tumor trial (NCT01772004).

Methods:

Eligible patients with R/M SCCHN were aged ≥18 years and had received ≥1 line of platinum-based chemotherapy with disease progression or recurrence within 6 months of the last dose or were ineligible for platinum-based chemotherapy. All patients received avelumab 10 mg/kg every 2 weeks. Tumor assessments were carried out by a blinded independent review committee (IRC) and investigators according to Response Evaluation Criteria in Solid Tumors V.1.1 (RECIST 1.1). Key endpoints included best overall response, duration of response (DOR) and progression-free survival (PFS) assessed by IRC and investigator per RECIST 1.1, overall survival (OS), and safety.

Results:

Between April 24, 2015, and November 13, 2015, 153 patients were enrolled. Patients had a median of two prior lines of therapy for metastatic or locally advanced disease (range 0–6); 12 patients (7.8%) were not eligible for platinum-based chemotherapy. At data cut-off (December 31, 2017), the confirmed objective response rate was 9.2% (95% CI 5.1% to 14.9%) assessed by IRC and 13.1% (95% CI 8.2% to 19.5%) assessed by investigator. Median DOR was not reached (95% CI 4.2 to not estimable) based on IRC assessment. Median PFS was 1.4 months (95% CI 1.4 to 2.6) assessed by IRC and 1.8 months (95% CI 1.4 to 2.7) assessed by investigator; median OS was 8.0 months (95% CI 6.5 to 10.2). Any-grade treatment-related adverse events (TRAEs) occurred in 83 patients (54.2%) and were grade ≥3 in 10 patients (6.5%). The most common TRAEs were fatigue (n=19, 12.4%), fever (n=14, 9.2%), pruritus (n=12, 7.8%), and chills (n=11, 7.2%), and there were no treatment-related deaths.

Conclusion:

Avelumab showed clinical activity and was associated with a low rate of grade ≥3 TRAEs in heavily pretreated patients with platinum-refractory/ineligible R/M SCCHN.

01 Dec 2018·Clinical drug investigationQ4 · MEDICINE

Bioequivalence and Pharmacokinetics of Bisoprolol–Amlodipine 5 mg/5 mg Combination Tablet versus Bisoprolol 5 mg Tablet and Amlodipine 5 mg Tablet: An Open-Label, Randomized, Two-Sequence Crossover Study in Healthy Chinese Subjects

Q4 · MEDICINE

Article

Author: Zhou, Dongli ; Zhao, Zirun ; Zhang, Lan ; Gao, Dan ; Huang, Yue ; Li, Lin ; Wang, Chunhua ; Hu, Xiao ; Chen, Xiaoping ; Hu, Chaoying

BACKGROUND:

The pharmacokinetics of bisoprolol and amlodipine administered as a fixed-dose combination (FDC) tablet have not been sufficiently studied in healthy Chinese subjects to support a medical need for using the FDC in hypertension.

OBJECTIVE:

This study was conducted to compare the pharmacokinetic profiles of the bisoprolol-amlodipine FDC tablet with the bisoprolol tablet and amlodipine tablet administered concomitantly under both fasting and fed conditions.

METHODS:

An open-label, randomized, two-period, two-sequence crossover study was designed under both fasting and fed conditions. The plasma concentrations of bisoprolol and amlodipine were analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, and the pharmacokinetic parameters of maximum concentration (C_max) and area under the concentration-time curve (AUC) were used to evaluate bioequivalence.

RESULTS:

The point estimate of geometric mean ratios of C_max and AUC from the time of dosing to the last measurable concentration (AUC_t) for bisoprolol were 97.85% and 99.46% in the fasting state, and 93.87% and 98.95% in the fed state, respectively. For amlodipine, the geometric mean ratios of C_max and AUC_t were 100.03% and 96.76% in the fasting state, and 106.56% and 103.07% in the fed state. No cases of treatment-emergent adverse events were reported during the entire study period.

CONCLUSIONS:

Bioequivalence was achieved for bisoprolol and amlodipine FDC under both fasting and fed conditions, and all treatments were safe and well tolerated by all study subjects.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT03226275.

100 Deals associated with Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

100 Translational Medicine associated with Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

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