PATIENTS | TheraCIM

Receiving additional treatment benefit and not worsening your wellbeing

TheraCIM

TheraCIM: More Than Survival

Highlights

  • Treatment Type
    TheraCIM (Nimotuzumab) is a monoclonal antibody used for the treatment against EGFR involved in the spreading and survival of cancer cells.
  • Safe to use
  • TheraCIM is given, it does not add toxicity to your other concurrent treatment. To date over 65,000 patients have used TheraCIM and only 2.3% of the patients have reported related-serious adverse events with the treatment, making TheraCIM the safest drug in its class targeting EGFR receptor.
  • Long-term use
    TheraCIM is well tolerated even when it was used for longer periods beyond TheraCIM standard treatment (which is normally for 60 days).
  • Simple administration
    Easy and effective administration time of 30-60 minutes, No premedication, No loading dose, No monitoring, and having standard dose per patients.
  • Can be used in children
    TheraCIM has been approved in several countries outside US, EU, Japan for glioma, which is a brain cancer in children arising from glial cells which are the most abundant cell types in the central nervous system.
  • Approved in countries outside US, EU and Japan
    TheraCIM has been approved in 25 countries outside US, EU and Japan, including China, India, Brazil, ASEAN and Latin America for head and neck cancer, glioma, esophageal, nasopharyngeal carcinoma and pancreatic cancer
  • Wide experience use
    TheraCIM has been successfully given to more than 65,000 patients to date and based on over 130 publications in peer review journals, 92 clinical studies and approvals in 25 countries for multiple tumor types

How TheraCIM can benefit you

Locally advanced unrescectable of head and neck cancer

What is locally advanced unresectable of head and neck cancer?
Head and neck cancer is a type of cancer that starts in the tissues and organs of the head and neck. They include cancers of the larynx (voice box), throat, lips, mouth, nose, and salivary glands. Most head and neck cancers begin in squamous cells, which are cells that line moist surfaces such as those inside the head and neck (for example, the mouth, nose, and throat). This type of head and neck cancer is called squamous cell carcinoma head and neck cancer (SCCHN)1. Locally advanced unresectable SCCHN is a stage of SCCHN which has spread from the site of the original tumor only to surrounding tissue or lymph nodes and cannot be removed completely through surgery2

 

How many people have head and neck cancer?
If you have head and neck cancer, you are not alone!
Head and neck cancer is a common cancer, with a number of new case in the world in 2012 is 600,000 cases3. Head and neck cancer is more common in men and was reported to have higher lifetime risk for men than for women3.

 

What are the risk factors for getting head and neck cancer?
It is important to know that having 1 or more risk factors does not mean that you will certainly have head and neck cancer and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that is associated with head and neck cancer, including:

 

Tobacco use4-7
Cigarette smoking is a strong risk factor for head and neck cancer independent of alcohol drinking. Smoking frequency, duration, and cumulative consumption is associated with increased risk for getting head and neck cancer6

Heavy alcohol use4-7
In the patients that never smokes, the association between alcohol consumption and the risk of head and neck cancer is only apparent at high doses of alcohol6.

Infection with human papillomavirus (HPV)8
HPV is a type of virus that is commonly transmitted sexually. HPV infection is high-risk for with one type of head and neck cancer that occur in oropharynx, which is in the middle part of the throat that includes the base of the tongue, the tonsils, the soft palate, and the walls of the pharynx8.

 

What are the treatment options for locally advanced unresectable head and neck cancer patients?

If you are diagnosed with locally advanced unresectable head and neck cancer, you will be receiving standard treatment of radiotherapy and chemotherapy combination.

 

TheraCIM has been studied in eight (8) completed clinical trials with a total number of 852 patients with head and neck cancer. Based on our phase II study9, if TheraCIM was added to the combination of radiotherapy and chemotherapy in patients with locally-advanced head and neck cancer, the possibility to stay alive at 5-year was 31% higher compared with radiotherapy and chemotherapy alone. The combination of TheraCIM, chemotherapy and radiotherapy was also showed to be well tolerated by patient9.

 

Your doctor may recommend treatment with TheraCIM based on the stage of your cancer, or your overall health. Please consult with your doctor for more information.

 

TheraCIM approval for locally advanced unresectable head and neck
Locally advanced unresectable SCCHN has been approved in several countries outside US, EU and Japan, including India, Argentina, Mexico, Thailand, El Salvador, Costa Rica, Myanmar, Bolivia, Ivory Coast, Nepal, Bhutan, Venezuela, Algeria, Vietnam, Cambodia, Mauritania, Somalia, Sri Lanka, Paraguay, Cuba, Peru.

 

Locally advanced unrescectable Nasopharyngeal cancer

What is Locally advanced unresectable nasopharyngeal cancer?
Nasopharyngeal carcinoma (NPC) is a type of cancer that arise from epithelial cells that line the surface of the nasopharynx. The nasopharynx is an air passage located at the very upper part of the throat, just behind the nose. NPC is a subtype of head and neck cancer, however risk factors, diagnosis and treatment is differed from other subtypes of head and neck cancer. Locally advanced unresectable of nasopharyngeal cancer is a stage of NPC which has spread from the site of the original tumor only to surrounding tissue or lymph nodes and cannot be removed completely through surgery11.

 

How many people have NPC?
NPC is fairly rare in the western world. However, in some countries NPC is particularly common, including in China, and Southeast Asia. In Southern China, the number of new cases is around 150 per 100,000 people. Younger-age (15-45 years of age) tends to have NPC compared with older age (65-74 years of age)11,12.

 

What are the risks for getting nasopharyngeal cancer?
It is important to know that having 1 or more risk factors does not mean that you will certainly have head and neck cancer and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that have been associated with Nasopharyngeal cancer, including:

 

Ethnicity and where you live
NPC is most common in southern China (including Hong Kong), Singapore, Vietnam, Malaysia, and the Philippines. It is also fairly common in Northwest Canada and Greenland.

  • Infection with the Epstein-Barr virus
  • Family history12,13

 

Treatment of locally advanced unresectable nasopharyngeal cancer?
If you are diagnosed with locally advanced unresectable NPC, you will be receiving standard treatment of chemotherapy and radiotherapy with or without initial chemotherapy12.

 

Use of Nimotuzumab in nasopharyngeal cancer has been studied in 1 completed clinical trial and 1 ongoing clinical trial with 140 and 482 subjects, respectively. Based on one of our phase II study14, if TheraCIM was added to radiotherapy following initial chemotherapy in patients with LA-NPC, the possibility to stay alive after 3 year was 94.8% compared with radiotherapy alone (93.5%). Patients that received Nimotuzumab has lower event of nausea, fatigue, low amount of platelets (thrombocytopenia) and red blood cells (anemia) compared to the radiotherapy group14.

 

Your doctor may recommend treatment with TheraCIM based on the stage of your cancer, or your overall health. Please consult with your doctor for more information.

 

Unresectable nasopharyngeal cancer approval
TheraCIM has been approved in unresectable nasopharyngeal cancer in countries outside US, EU and Japan including Cuba, and China

 

Glioma

What is Glioma?
Glioma is one of the most common types of tumor that occurs in the brain and spinal cord. Gliomas begin in the glial cell that surround nerve cells and help them function15,16. Glioma has different types based on their location and rate of growth. High grade glioma is a type of glioma that is more agressive and rapidly growing. High grade Glioma has high rate of progression and recurrence compared to low grade glioma15, 16, 17.How many people have Glioma?
High grade glioma is fairly rare. It is estimated that the number of adults having high grade glioma in 2015 is 11,882 with number of new cases 3 per 10,000 adults per year3,17.What are the risks for getting glioma?
It is important to know that having 1 or more risk factors does not mean that you will certainly have glioma and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that is associated with glioma:

  • Gender
    Male slightly has higher risk than females
  • Family history
    Genetically inhirited tendency
  • Ionising radiation15

 

What are the treatment options for high grade glioma?
If you are diagnosed with glioma, you will be given mainstay treatment of surgery followed by radiation and chemotherapy. However, most of the times, it is impossible to ever remove the tumor entirely through surgery17.

 

TheraCIM has been studied in 7 clinical trials with 530 adult and pediatric patients that were diagnosed with high grade glioma. Phase III clinical clinical trial studying TheraCIM use in combination with radiotherapy in adult patients with glioma showed longer survival of 17.76 months compared to patients that received radiotherapy alone with survival of 12.63 months18.

 

Your doctor may recommend treatment with TheraCIM based on the location, stage of your cancer, age or your overall health. Please consult with your doctor for more information.

 

TheraCIM approval for high grade glioma
TheraCIM has been approved for glioma in countries outside US, EU and Japan, including Thailand, Myanmar, Mexico, Philippines, Cuba, Ukraine and Argentine.

 

Pancreatic cancer

What is locally advanced and metastatic Pancreatic cancer?
Pancreatic cancer, specifically pancreatic ductal adenocarcinoma is a type of cancer that arises in the duct of gland in pancreas, which lies behind the stomach and in front of the spine19. Locally advanced pancreatic cancer is a type of pancreatic cancer which has spread from the site of the original tumor only to surrounding tissue or lymph nodes and cannot be removed completely through surgery. Metastatic pancreatic cancer is a type of pancreatic cancer that has spread to the distant sites or organs in the body11,19

How many people have Pancreatic cancer?
Pancreatic cancer is slightly rare with 338,000 of new cases in 20123. It was estimated that 85-90% of pancreatic cancer patients were presented with locally advanced or metastatic disease20.

What are the risks for getting Pancreatic cancer?
It is important to know that having 1 or more risk factors does not mean that you will certainly have pancreatic cancer and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that are associated with pancreatic cancer:

  • Smoking
  • Family history
  • Chronic pancreatitis
  • Diabetes mellitus
  • H. pylori infection
  • Non-O-blood group
  • Red meat intake
  • Alcohol
  • Obesity13, 21

What are the treatment options for locally-advanced or metastatic pancreatic cancer?
If you are diagnosed with locally advanced or metastatic pancreatic cancer, you will receive treatment options, including: single chemotherapy agent called Gemcitabine, Nab-paclitaxel (Abraxane©) in combination with Gemcitabine, combination of chemotherapy agents, FOLFIRINOX, and targeted anti cancer drug erlotinib (tarceva©)21. These options depend on the health condition of the patients.

 

TheraCIM has been studied in 2 clinical trials with patients that were diagnosed with locally advanced or metastatic pancreatic cancer22,23. Phase IIB/IIIA clinical trial studying TheraCIM use in combination with Gemcitabine in patients with locally advanced or metastatic pancreatic cancer showed longer survival of 8.6 months compared to patients that received Gemcitabine alone with 6.0 months23.

 

Your doctor may recommend treatment with TheraCIM based on the location, stage of your cancer, age or your overall health. Please consult with your doctor for more information.

TheraCIM approval for locally advanced and metastatic pancreatic cancer
TheraCIM has been approved for locally advanced and metastatic pancreatic cancer in Cuba.

Safety Information
Please refer to safety information attached in email

Prescription information
Please refer to prescription information attached in email

 

 

REFERENCES

  • ESMO/ACF Patient guide series head and neck cancer
  • Seiwert TY & Cohen EEW. 2005. State of the art management of locally advanced head and neck cancer. BJC 92: 1341-1348
  • Globocan. 2012
  • Gandini S, Botteri E, Iodice S, et al. 2008. Tobacco smoking and cancer: a meta-analysis. International Journal of Cancer 122(1):155–164.
  • Hashibe M, Boffetta P, Zaridze D, et al. 2006. Evidence for an important role of alcohol- and aldehyde-metabolizing genes in cancers of the upper aerodigestive tract. Cancer Epidemiology, Biomarkers and Prevention 15(4):696–703.
  • Hashibe M, Brennan P, Benhamou S, et al. 2007. Alcohol drinking in never users of tobacco, cigarette smoking in never drinkers, and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Journal of the National Cancer Institute ; 99(10):777–789.
  • Boffetta P, Hecht S, Gray N, Gupta P, Straif K. Smokeless tobacco and cancer. 2008. The Lancet Oncology ; 9(7):667–675.
  • Chaturvedi AK, Engels EA, Pfeiffer RM, et al. 2011. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. Journal of Clinical Oncology ; 29(32):4294–4301.
  • Gregoire V, Lefebvre JL, Licitra L, Felip E. 2010. Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO clinical practice guidelines. Ann Oncol : vi184-vi186
  • Reddy BK, Lokesh V, Vidyasagar MS. 2014. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol. 50(5):498-505
  • Edge SB & Compton CC. The American Joint committee on cancer: the 7th edition of the AJCC Cancer Staging Manual and the future of TNM. Ann Surg Oncol. 2010. 17: 1471
  • Chan ATC, Gregoire V, Lefebvre JL, et al. 2013. Nasopharyngeal cancer: EHNS-ESMO-ESTRO clinical practice guidelines. Ann Oncol. 23: vii83-vii85.
  • American Cancer Society. Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.
  • Kong L, Lin Q, Hu C, et al. 2016. Radiation plus concurrent nimotuzumab versus CDDP in locally advanced nasopharyngeal cancer. Results of phase III randomized trial. J Clin Oncol 34.
  • Adult Gliomas (Astrocytomas and oligodendrogliomas): A guide for patients, their families and carers. 2011. Clinical oncological Society of Australia.
  • Glioma: A guide for patients. Information based on ESMO Clinical Practice Guidelines.v2016.1.
  • Stupp R, Brada M, Bent VD, et al. 2014.High grade glioma: ESMO clinical practice for diagnosis, treatment and follow-up. Ann Oncol. 25: 93-101.
  • Solomon MT, Selva, JC, Figueredo J. 2013. Radiotherapy plus nimotuzumab or placebo in the treatment of high grade glioma patients: results from a randomized, double blind trial. BMC Cancer.
  • The Lustgarten Foundation for pancreatic cancer research. 2012. Understanding pancreatic cancer.
  • Cardenes HR, Chiorean EG, DeWitt J, et al. 2006. Locally Advanced Pancreatic cancer: Current Therapeutic approach. The Oncologist 11: 612-623.
  • Ducreux M, Cuhna AS, Caramella C, et al. 2015. Cancer of the pancreas: ESMO clinical practice guidelines for diagnosis, treatment and follow up. Ann Oncol 26: v56–v68.
  • Strumberg D, Schultheis B, Scheulen ME, Hilger RA, Krauss J, Marschner N, Lordick F, Bach F, Reuter D, Edler L, Mross K. 2012.Phase II study of nimotuzumab, a humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody, in patients with locally advanced or metastatic pancreatic cancer.  Invest New Drugs. 30:1138-43.
  • Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, et al. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol.
  • https://www.cancer.org/latest-news/be-a-healthier-cancer-survivor.html
  • https://www.oncolink.org/support/sexuality-fertility/sexuality/women-s-guide-to-sexuality-during-after-cancer-treatment