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Roche (RHHBY)'s Avastin: First Biologic Backed In EU For Resistant Ovarian Cancer


6/27/2014 9:03:05 AM

CHMP Recommends EU Approval Of Roche’s Avastin For Platinum-Resistant Recurrent Ovarian Cancer

* Avastin is the first biologic medicine to receive a CHMP positive opinion for the most difficult to treat form of ovarian cancer
* The positive opinion is based on a pivotal phase III study showing that the addition of Avastin to chemotherapy reduced the risk of disease worsening or death by 62 percent


Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the use of Avastin® (bevacizumab) in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy. Ovarian cancer has the highest mortality rate of all gynaecological cancers.1 Of the 230,000 women diagnosed worldwide each year many will have advanced disease that will return after initial treatment.1-3

“Women with platinum-resistant ovarian cancer have limited medicines available for their difficult disease,” said Sandra Horning M.D., Chief Medical Officer and Head, Global Product Development. “EU approval of Avastin for platinum-resistant ovarian cancer would be an important step in helping these women live longer without their disease progressing, and we look forward to receiving the final decision from the European Commission in the coming months.”

When treating recurrent ovarian cancer, the time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-resistant’ disease if their disease worsens between one and six months following completion of their platinum-based chemotherapy, and ‘platinum-sensitive’ disease if it worsens more than six months after. A quarter of those who relapse after initial treatment - nearly 60,000 women a year globally - will have platinum-resistant cancer, the most difficult to treat form of the disease. Median overall survival of patients with platinum-resistant ovarian cancer is approximately 12 months,4 and novel strategies are needed.

Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein linked to tumour growth and spread.5 Studies have shown a correlation between a high concentration of VEGF and ascites development (excess fluid in the abdominal cavity), disease worsening, and a poorer prognosis in women with ovarian cancer.5 Avastin is designed to specifically target VEGF and is currently the only targeted therapy approved by the European Medicines Agency (EMA) for ovarian cancer. Avastin is EU approved as a front-line (first line following surgery) treatment of advanced ovarian cancer, and as a treatment for recurrent, platinum-sensitive ovarian cancer.

The new EU filing was based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) or Avastin added to chemotherapy.4 Results showed that at a median follow-up of 13 months for women who had received chemotherapy alone and 13.9 months for those who had received the combination, the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median PFS from 3.4 months to 6.7 months (HR=0.38, p<0.0001).4,6 AURELIA is the fourth phase III study of Avastin in ovarian cancer (following GOG 0218, ICON7 and OCEANS) to show that adding Avastin to chemotherapy significantly increased the time women with ovarian cancer lived without their disease getting worse.4,7-9 AURELIA additional study results

* Women with recurrent, platinum-resistant ovarian cancer who received Avastin in combination with chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) had a median overall survival of 16.6 months compared to 13.3 months for women treated with chemotherapy alone (HR=0.87, p=0.27).4
* In addition, women who received Avastin in combination with chemotherapy had a significantly higher rate of tumour shrinkage (objective response rate, ORR) compared to women who received chemotherapy alone (28.2 percent versus 12.5 percent, p=0.0007).4
* The results of prespecified Quality of Life (QoL) analyses indicated that the benefits of Avastin in AURELIA extended beyond the prolongation of PFS to include greater improvements in ovarian cancer associated abdominal/gastrointestinal symptoms.6,10
* No new safety findings were observed in the AURELIA study and adverse events were consistent with those seen in previous trials of Avastin across tumour types for approved indications.4

About the AURELIA study4

AURELIA is a multicentre, randomised, open-label, two-arm phase III study in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. Women in AURELIA had received no more than two anticancer regimens prior to enrolment in the trial. The trial was designed to evaluate Avastin (10mg/kg every two weeks or 15mg/kg every three weeks) in combination with standard chemotherapy (either weekly paclitaxel or topotecan or pegylated liposomal doxorubicin) compared to standard chemotherapy alone.

The trial was set up in cooperation with the Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and was conducted by the international network of the Gynecologic Cancer Intergroup (GCIG) and the pan-European Network of Gynaecological Oncological Trial Groups (ENGOT). The primary endpoint of the study was progression-free survival. The secondary endpoints of the study included overall survival, objective response rate, Quality of Life, safety and tolerability.

About ovarian cancer

Ovarian cancer causes more deaths than any other gynaecologic cancer. It is the seventh most commonly diagnosed cancer in women, with an estimated 230,000 cases diagnosed around the world every year and there are approximately 140,000 deaths from the disease making it the deadliest cancer of all gynaecological cancers.1 Surgery to remove as much of the tumour as possible is a mainstay of treatment but unfortunately, the majority of patients are diagnosed with late stage disease (when the cancer has grown or spread) and they require further treatment.2, 3, 11 About Avastin – over 10 years of transforming cancer care

With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the US and over 60 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over 1.5 million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types. About Avastin – mechanism of action

An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) – a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF. Precise VEGF inhibition by Avastin allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com

All trademarks used or mentioned in this release are protected by law.

References 1. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Last accessed June 2014 at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx 2. Heintz A et al. Int J Gynaecol Obstet 2006; 95 (Suppl 1):S161–192 3. Hennessy B et al. Lancet 2009; 9698:1371-1382 4. Roche data on file 5. Teoh G et al. Antiangiogenic Therapies in Epithelial Ovarian Cancer. The Role of Vascular Endothelial Growth Factors in Ovarian Cancer. Last accessed June 2014 at http://www.medscape.com/viewarticle/738259_3 6. Errico A. Nat Rev Clin Oncol 2014; 11, 242 7. Burger RA et al. N Engl J Med 2011; 365:2473-2483 8. Perren TJ et al. N Engl J Med 2011; 365:2484-2496 9. Aghajanian C et al. J Clin Oncol 2012; 30(17):2039-2045 10. Stockler MR et al J Clin Oncol 2014; 32:1309–1316 11. Gubbels J et al. J Ovarian Res 2010;3:8

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