Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
First new systemic therapy in more than 15 years for cancer related to asbestos exposure
Approved , BMS
MONTREAL, QUEBEC – June 2, 2021 – Today, Bristol Myers Squibb Canada (BMS) announced Health Canada’s approval of OPDIVO® (nivolumab) 360 mg every three weeks or 3mg/kg every two weeks plus YERVOY® (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.[i] This is the first and only dual immunotherapy treatment for the condition. Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells.[ii]
“Malignant pleural mesothelioma is a devastating cancer commonly related to exposure to asbestos. When faced with a diagnosis, patients currently have very few treatment possibilities,” said Dr. Quincy Chu, medical oncologist, Cross Cancer Institute, Edmonton. “This approval is particularly important because it is the first dual immunotherapy developed to treat this disease. That means we now have an entirely new therapeutic option, helping us better support Canadian patients diagnosed with mesothelioma.”
Mesothelioma is a rare and aggressive form of cancer that is mainly caused by asbestos exposure.[iii] Mesothelioma most often affects the pleural lining (the lining surrounding the lungs).[iv] Currently in Canada, the overall 5-year survival rate for mesothelioma is 7%.[v] Malignant Pleural Mesothelioma (MPM) accounts for approximately 80%–85% of cases.[vi]
“Today's approval represents an important step in addressing the challenging needs of people diagnosed with this devastating, life threatening cancer most commonly found in the lining surrounding the lungs, said Eudice Goldberg, Chair, Board of Directors, Canadian Mesothelioma Foundation. “With a poor long-term survival rate, any new treatments are welcomed by the mesothelioma community."
The Health Canada approval was based on a pre-specified interim analysis from the Phase 3 CheckMate-743 trial in which OPDIVO®+YERVOY® demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy.[vii] The primary endpoint of the trial was OS in all randomized patients.i Additional efficacy outcome measures included progression-free survival (PFS), and objective response rate (ORR).i
“We are pleased and proud to have OPDIVO® + YERVOY® now approved for the treatment of patients diagnosed with the most common form of mesothelioma,” said Al Reba, General Manager, BMS Canada. “At BMS, our commitment to patients is an everyday, all-the-time promise. We continue to pursue innovative therapies that can help improve both patients’ survival and quality of life.”
CheckMate-743 (NCT02899299) is an open-label, multi-center, randomized Phase 3 trial evaluating OPDIVO® plus YERVOY® compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with histologically confirmed unresectable malignant pleural mesothelioma and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy.[viii]
Health Canada and Project Orbis Collaboration Aims to Provide Earlier Availability to Cancer Treatments[ix]
Project Orbis is an initiative of the United States Food and Drug Administration (FDA) Oncology Center of Excellence. This submission was part of the FDA’s Project Orbis initiative, enabling concurrent review by the health authorities in the United States, Australia, Brazil, Switzerland and Canada.
About Bristol Myers Squibb Canada Co.
Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb Canada Co. employs more than 400 people across the country. For more information, please visit https://www.bms.com/ca/en.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
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[i] Canadian Product Monograph. Revised May 28, 2021.
[ii] Canadian Cancer Society. Immunotherapy. https://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/chemotherapy-and-other-drug-therapies/immunotherapy/?region=on. Accessed Nov 4, 2020.
[iii] https://survivornet.ca/learn/health-concerns-for-cancer-patients/asbestos-mesothelioma-lung-cancer/mesothelioma/ Accessed Nov 4, 2020.
[v] Canadian Cancer Society Survival statistics for mesothelioma. http://www.cancer.ca/en/cancer-information/cancer-type/mesothelioma/prognosis-and-survival/survival-statistics/?region=on Accessed Nov 4, 2020.
[vi] Shavelle R et al. Lung Cancer Int. 2017; http://dx.doi.org/10.1155/2017/2782590
[vii] Clinical trial (n=302) (Hazard Ratio [HR]: 0.74 [95% Confidence Interval [CI]: 0.61 to 0.89]; P=0.002), with a median OS (mOS) of 18.1 months (95% CI: 16.8 to 21.5) versus 14.1 months (95% CI: 12.5 to 16.2), respectively.1 These results were observed after 22.1 months of minimum follow-up.3 At two years, 41% of patients treated with Opdivo + Yervoy were alive and 27% with chemotherapy.
[viii] https://clinicaltrials.gov/ct2/show/NCT02899299?term=CheckMate-743&cond=Mesothelioma&draw=2&rank=1 Accessed Nov 4, 2020.
[ix] U.S. Food and Drug Administration. Project Orbis. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Accessed Nov 4, 2020.