Novartis leukemia drug Arzerra phase III clinical effect is significant

June 16, 2015 Source: Medical Valley

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Recently, Novartis released data on a Phase III COMPLEMENT-2 study of the leukemia drug Arzerra (ofatumumab) in the transaction. The study was conducted in patients with relapsed chronic lymphocytic leukemia (CLL) and data showed that Arzerra combined with fludarabine and cyclophosphamide resulted in median progression-free survival compared with fludarabine + cyclophosphamide treated group (PFS: 28.9 months vs 18.8 months, p=0.0032) showed a statistically significant improvement with an improvement of 54%. Relevant data has been submitted to the 20th European Society of Hematology (EHA) Annual Meeting in Vienna, Austria, June 11-14.

This is also the second positive top-line data for Novartis's Arzerra treatment CLL announced this year. A phase III study, published in April this year, is a chronic lymphocytic leukemia (CLL) that is not suitable for fludarabine treatment due to age or comorbidities (including hypertension, diabetes, heart disease or chronic obstructive pulmonary disease) In the newly diagnosed patients, data showed that Arzerra combined with chlorambucil chemotherapy resulted in progression-free survival (PFS: 22.4 months vs 13.1 months, p<0.0001) compared with chlorambucil chemotherapy. Significant improvement in statistical significance, an improvement of 77%. Relevant data has been published in the international journal Lancet.

COMPLEMENT-2 (NCT00824265) is an open-label, two-group, randomized phase III study conducted in 365 patients with recurrent chronic lymphocytic leukemia (CLL) in 18 countries. In the study, patients were randomly assigned to a 6-cycle Arzerra (ofatumumab, O) + fludarabine (F) + cyclophosphamide (C) combination therapy (OFC), or 6 cycles of fluoride in a 1:1 ratio. Durabin (F) + cyclophosphamide (C) combination therapy (FC). The primary end point of the study was progression-free survival (PFS), which was assessed by the Independent Review Committee (IRC); secondary endpoints included total response rate (ORR), complete response rate (CR), overall survival (OS), and patient self. Report results, time to remission, duration of remission (DoR), time to disease progression, time to next treatment (TTNT), safety, patient care.

Data on secondary endpoints included duration of remission (DoR), 29.6 months in the OFC treatment group, 24.9 months in the FC treatment group (p=0.0878), and disease progression time, 42.1 months in the OFC treatment group, FC treatment The group was 26.8 months (p=0.0036). In terms of safety, there were more patients with grade 3 or higher adverse events (AEs: 74% vs 69%) in the OFC treatment group; grade 3 and above neutropenia were higher in the OFC treatment group than in the FC treatment group (53) % vs 39%).

Arzerra (ofatumumab), jointly developed by GlaxoSmithKline (GSK) and Genmab, is an innovative, fully humanized monoclonal antibody that targets an epitope of the CD20 molecule on the B cell surface, which epitope contains The extracellular macrocycle and small loop structure of the CD20 molecule. Arzerra was approved by the FDA and EMA in 2009 and 2010 for the treatment of non-responsive chronic lymphocytic leukemia (CLL) patients with the standard drug [alemtuzumab (Campath) or fludarabine]. .

Patient Monitor

Features
10.1 inch high resolution color TFT display
Lightweight and portable design suitable for Ambulance,Emergency Transport
Three Working Modes : Monitoring , Surgery and Diagnosis.
Simple and friendly operating display interface.
Multi-display modes suitable for different applications: Standard Interface , Large font , ECG Standard Full Display ,OXY, Trend able BP Trend.
Built-in high capacity battery up to 3 hours of continuous work


Technique Specification
ECG
Lead Mode : 5 Leads ( I , ll , Ill , AVR , AVL , AVF , V )
Gain : 2.5mm / mV, 5.0mm /mV , 10mm /Mv, 20mm /mV
Heart Rate : 15-300 BPM ( Adult ) ; 15-350 BPM ( Neonatal )
Resolution : 1 BPM
Accuracy : ± 1%
Sensitivity > 200 uV ( Peak to peak )
ST measurement range : -2.0 ~+ 2.0 Mv
Accuracy : -0. 8mV~+ 0. 8mV : ± 0. 02mV or ± 10% , which is greater
Other Range : unspecified
Sweep speed : 12.5 mm / s , 25mm / s , 50mm / s
Bandwidth:
Diagnostic : 0.05~130 Hz
Monitor : 0.5~40 Hz
Surgery : 1~20 Hz

SPO2
Measuring Range : 0 ~ 100%
Resolution : 1%
Accuracy : 70%~100% ( ± 2 % )
Pulse Rate : 20-250 BPM
Resolution : 1 BPM
Accuracy : ± 3 BPM

Optinal Parameters :
Central monitoring system
Dual IBP
Etco 2
12-lead ECG
Nellcor SpO2
Sun Tech NIBP

NIBP
Method : Oscillometry
Measure mode Manual, Auto, STAT
Unit : mmHg , kPa
Measure and alarm range:
Adult Mode
SYS 40 ~ 280 mmHg
DIA 10 ~ 225 mmHg
MEAN 20 ~ 240 mmHg

Pediatric Mode
SYS 40 ~ 220 mmHg
DIA 10 ~ 160 mmHg
MEAN 20 ~ 170 mmHg

Neonatal Mode
SYS 40 ~ 135 mmHg
DIA 10 ~ 100 mmHg
MEAN 20 ~ 110 mmHg
Resolution : 1 mmHg
Accuracy : ± 5 mmHg

TEMP
Measure and Alarm Range : 0 ~ 50 C
Resolution : 0 . 1C
Accuracy : ± 0 . 1C

Standard Parameters
ECG, RESP, TEMP, NIBP, SPO2, PR

RESP
Method : Impedance between RA-LL or RALA
Measurement Range:
Adult : 10~120 BrPM
Neonatal / Pediatric : 7~150 BrPM
Resolution : 1 BrPM
Accuracy : ± 2 BrPM

Standard Configuration
No Item Qty

  1. 1 Main Unit 1
  2. 2 5-lead ECG cable 1
  3. 3 Disposable ECG Electrode 5
  4. 4 Adult Spo2 probe 1
  5. 5 Adult NIBP cuff 1
  6. 6 NIBP extension tube 1
  7. 7 Temperature probe 1
  8. 8 Power Cable 1
  9. 9 User Manual 1
  10. 10 Fuse 3

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