癌症治疗新模式：短期使用Removab可产生长期免疫反应
据悉，Trion制药公司公布了关于Catumaxomab（Removab）的两项研究结果，证明该药可强效激活免疫系统产生以往只有通过接种疫苗才能达到的免疫反应。
上述数据是两个独立的研究小组使用Catumaxomab治疗恶性腹水和胃癌获得的。这些结果在美国临床肿瘤学会（ASCO）年会上公布。
在腹膜内给予Catumaxomab后，观察发现约一半的恶性腹水患者和大部分胃癌患者有抗肿瘤抗原的抗体显著增加。在这两项研究中，抗体反应并不只针对Catumaxomab的靶抗原EpCAM，还针对其它的癌抗原，这表明诱导产生了抗个体肿瘤的全面体液免疫反应。四分之三的接受第二疗程治疗的患者显示出更强的免疫效应，与众所周知的重复接种疫苗引起的复强反应相当。
在胃癌研究中，还分析并确认了细胞免疫反应。据发现，在治疗后4周，EpCAM-特异性外周T细胞群会大大扩增。
Catumaxomab不仅可诱导直接的肿瘤细胞破坏，还对个体肿瘤有长期免疫效果。
Trion制药公司首席执行官HorstLindhofer称，相比现有的单特异性或双特异性抗体方法，此疫苗具有一项决定性优势，即不需要用Catumaxomab进行永久治疗。如果他们下一步能将这些数据与临床效果对比，就会为以抗体为基础的癌症疗法提供一种模式转换，即从长期治疗转变为具有长期效应的短期治疗
Removab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Removab Generic Name
Catumaxomab
Type
POM
catumaxomab (Removab®)
catumaxomab (Removab®) 10 micrograms concentrate for solution for infusion
catumaxomab (Removab®) 50 micrograms concentrate for solution for infusion
New Drugs Online Report for catumaxomab
Information
Generic Name: catumaxomab
Trade Name: Removab
Entry Type: New molecular entity
Development and Regulatory status
UK: Launched
EU: Launched
US: None
UK launch Plans: Available only to registered users
Actual UK launch date: May 2011
Comments
Granted orphan drug status in the EU for treatment of gastric cancer in Nov 06 (EU/3/06/414) [6].
25/11/2011 16:57:51
May 11: Launched in the UK [5].
20/06/2011 09:54:38
Jan 11: Swedish Orphan Biovitrum has signed a distribution agreement with Fresenius Biotech which allows them to distribute catumaxomab exclusively in 15 European countries (Sweden, Denmark, Norway, Finland, Iceland, Poland, Czech Republic, Slovakia, Slovenia, Romania, Bulgaria, Hungary, Estonia, Latvia & Lithuania) over 7 yrs [4].
16/06/2011 11:30:48
Apr 09: EU approves catumaxomab for IP treatment of malignant ascites in pts with epithelial cell adhesion molecule (EpCAM)-positive carcinomas (3).
28/04/2009 10:09:51
EU licence application submitted Dec 07. Positive approval granted Feb 09 (1)
22/02/2009 19:39:51
Trial or other data
IP-CAT-AC-03 - CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers. Safety data from IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting. This study will eva luate the tolerability of 3 hour infusions with and without premedication of prednisolone (2).
22/02/2009 22:03:42
IP-REM-AC-02-US - a PII study in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each patient will receive four ascending doses of catumaxomab, administered intraperitoneally as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in the study for up to 7 months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the lifetime of the patient (2)
22/02/2009 21:56:55
IP-REM-AC-01 study - a PII/III study in 258 patients stratified as having or not having ovarian cancer. Catumaxomab increased time to tumour progression (1)
22/02/2009 21:52:52
Evidence Based eva luations
AWMSG http://www.wales.nhs.uk/sites3/Documents/371/Non%20engagement%20notice13.pdf
Other http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000972/WC500051808.pdf
References
Available only to registered users
Category
BNF Category: Malignant disease and immunosuppression (08)
Pharmacology: Apoptosis stimulant - binds to EpCAM (expressed on almost all carcinomas) & recruits T-cells & accessory cells (macrophages & natural killer cells) to the tumour site
Epidemiology: Malignant ascites occur in 15 to 50% of patients with cancer, especially breast, bronchus, endometrium, ovary, stomach, pancreas and colon cancer. EpCAM is over-expressed in epithelial tumours such as these. Median survival is 1 to 4 months.
Indication: Ascites
Additional Details: malignant ascites
Method(s) of Administration
Intraperitoneal
Company Information
Name: Fresenius Biotech
US Name: Fresenius Biotech
Further Information
Anticipated commissioning route (England) -
High cost drug list? Awaiting Update
Implications Available only to registered users |
