Biologic treatment option now available to Canadian women living with advanced ovarian cancer

MISSISSAUGA, ON, Oct. 5, 2015 /CNW/ - Today, Roche Canada announced that Health Canada has approved Avastin® (bevacizumab), in combination with chemotherapy, to treat patients with recurrent ovarian cancer. Until recently, only chemotherapy¹ and surgery² were available for Canadians diagnosed with advanced disease.

Avastin is now approved, in combination with specific chemotherapy, to treat women following their first recurrence platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer or for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens.

"The approval of Avastin is an important advancement in the treatment of recurrent ovarian cancer as it offers women with advanced disease a novel therapy that can have meaningful improvements in their care and delay their cancer from progressing," says Dr. Michael Fung-Kee-Fung, Gynecologist, Oncologist, Professor of Obstetrics and Gynaecology, University of Ottawa and Head of Surgical Oncology, The Ottawa Hospital. "Most women with advanced ovarian cancer will experience progression of their disease after their initial treatment with surgery and chemotherapy, so the need for additional options is important."

There is no effective screening test that can detect ovarian cancer early,³ and as a result, the majority of patients are diagnosed at a late stage, when treatment becomes more difficult⁴ and survival is typically less than five years.⁵

"Ovarian cancer is a devastating disease," says Elisabeth Baugh, Chief Executive Officer, Ovarian Cancer Canada. "Symptoms can easily be overlooked and underdiagnosed. This too often results in late-stage diagnosis with limited options and poor prognoses. It's encouraging to see continued research in this area and a new option available for Canadian women living with this disease."

About Ovarian Cancer

It is estimated that 2,800 Canadians will be diagnosed with ovarian cancer this year and 1,750 will die from the disease.⁶

The majority of women with ovarian cancer receive a platinum-based chemotherapy regimen as front-line treatment after surgery. Women are said to have "platinum-sensitive" ovarian cancer if the disease recurs more than six months after completing platinum-based chemotherapy. Women are considered to have "platinum-resistant" ovarian cancer if the disease recurs less than six months after completing platinum-based chemotherapy.⁷

About the Health Canada approval of Avastin

Platinum-sensitive approval

The approval for recurrent platinum-sensitive ovarian cancer is based on the outcomes of the pivotal, Phase III, randomized, multi-center, double-blind, placebo-controlled OCEANS study, which assessed the efficacy and safety of Avastin with chemotherapy (gemcitabine and carboplatin) in 484 women with platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer.⁸ Sub-group analysis of the Phase III OCEANS study indicated that the combination of Avastin with carboplatin and gemcitabine chemotherapy was effective in all sub-groups of women with platinum-sensitive recurrent ovarian cancer.⁹ In platinum-sensitive recurrent ovarian cancer, the combination of Avastin and chemotherapy followed by the continued use of Avastin alone showed a four-month improvement in median progression free survival from 8.4 months to 12.4 months, compared to chemotherapy alone (p<0.0001).¹⁰

The most frequent (≥20%) adverse events observed in the Avastin arm were anemia, neutropenia, thrombocytopenia, abdominal pain, constipation, diarrhea, nausea, vomiting, fatigue, arthralgia, back pain, dizziness, headache, insomnia, cough, dyspnea, epistaxis, alopecia, rash, and hypertension. The most frequent (≥20%) adverse events observed in the chemotherapy arm were anemia, neutropenia, thrombocytopenia, abdominal pain, constipation, diarrhea, nausea, vomiting, fatigue, decreased appetite, headache, peripheral neuropathy, dyspnea, alopecia, and rash.¹¹

Platinum-resistant approval

The approval for recurrent platinum-resistant ovarian cancer is based on the outcomes of the Phase III, randomized, multi-center, open-label AURELIA study, which assessed the use of Avastin in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. In platinum-resistant recurrent ovarian cancer, Avastin combined with chemotherapy (paclitaxel, topotecan or pegylated liposomal doxorubicin) doubled the median progression free survival from 3.4 months to 6.8 months, compared to chemotherapy alone (p<0.0001).¹² 

The most frequent (≥20%) all-grade adverse events occurring in the Avastin plus paclitaxel arm were neutropenia, fatigue, peripheral sensory neuropathy, alopecia, and hypertension. The most frequent events occurring in the paclitaxel-only arm were neutropenia, fatigue, and peripheral sensory neuropathy.

The most frequent (≥20%) events occurring in the Avastin plus PLD arm were mucosal inflammation, fatigue, proteinuria, palmar-plantar erythrodysaesthesia syndrome, and hypertension. The most frequent events occurring in the PLD-only arm were fatigue.

The most frequent (≥20%) events occurring in the Avastin plus topotecan group were neutropenia, anemia, and fatigue. The most frequent events occurring in the topotecan-only arm were neutropenia, anemia, and leukopenia.¹³

About Avastin

Avastin (bevacizumab) is a recombinant humanized monoclonal antibody that selectively binds to and neutralizes the biologic activity of human vascular endothelial growth factor (VEGF).

An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasize) 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.¹⁴

Avastin is also approved in both the United States and the European Union (EU) for recurrent platinum-resistant ovarian cancer and in the EU for recurrent platinum-sensitive ovarian cancer. It is also approved in Canada for metastatic colorectal cancer, locally advanced, metastatic or recurrent non-small cell lung cancer and malignant glioma (WHO grade IV) – glioblastoma (notice of compliance with conditions).¹⁵

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, infectious diseases, inflammation, metabolism 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 personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life, and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 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.

Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

All trade-marks used or mentioned are legally protected

References
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¹Ovarian Cancer Canada. "Chemotherapy." http://www.ovariancanada.org/about-ovarian-cancer/treatment/chemotherapy. Accessed August 18, 2015.
² Ovarian Cancer Canada. "Surgery." http://www.ovariancanada.org/about-ovarian-cancer/treatment/surgery. Accessed August 18, 2015.
³ Badgwell D, Bast RC. Early detection of ovarian cancer. Dis Markers. 2007;23(5-6):397-410.
⁴ Roett MA, Exans P. Ovarian cancer: An overview. American Academy of Family Physicians (2009). 80(6):609-16.
⁵ American Cancer Society. "Cancer Facts and Figures 2015." http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf. Accessed August 12, 2015.
⁶ Canadian Cancer Society. "Ovarian Cancer Statistics." http://www.cancer.ca/en/cancer-information/cancer-type/ovarian/statistics/?region=on. Accessed August 12, 2015.
⁷Olivia W. Foley, BS, J. Alejandro Rauh-Hain, MD, and Marcela G. Del Carmen, MD, MPH. Oncology April 15, 2013. "Recurrent Epithelial Ovarian Cancer: An Update on Treatment." http://www.cancernetwork.com/oncology-journal/recurrent-epithelial-ovarian-cancer-update-treatment. Accessed on September 2, 2015.
⁸Avastin Product Monograph. Last updated September 28, 2015
⁹Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039-45.
¹⁰Avastin Product Monograph. Last updated September 28, 2015
¹¹Avastin Product Monograph. Last updated September 28, 2015.
¹²Avastin Product Monograph. Last updated September 28, 2015.
¹³Avastin Product Monograph. Last updated September 28, 2015.
¹⁴Avastin Product Monograph. Last updated September 28, 2015
¹⁵Avastin Product Monograph. Last updated September 28, 2015.

SOURCE Roche Canada

Kate Hanna, Roche Canada, 905-285-7729, [email protected]; Erin Collett, Edelman, 416-849-8911, [email protected]