Quebec is the first province to list OPDUALAG™ on its public drug plan for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma

MONTREAL, QUEBEC – September 26, 2024 – Bristol Myers Squibb Canada (BMS) is pleased to announce that OPDUALAG™ (nivolumab and relatlimab) is now included on the Liste des Médicaments- Établissements for the first-line treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma[1], and have an ECOG performance status of 0 or 1.[2]

“Since the approval of the first immune checkpoint inhibitor more than ten years ago, we’ve seen immunotherapy alone, and in combination, revolutionize the treatment of patients with advanced melanoma,” said Dr. Wilson Miller, Director, Clinical Research Unit, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec. “Today's news is important as it provides eligible patients in Quebec with an additional combination checkpoint inhibitor – an option to better tailor therapy, address patient-specific needs and potentially offer improved outcomes.”

Metastatic melanoma is the deadliest form of skin cancer.[3] The incidence of melanoma has been increasing for the last 30 years.[4] OPDUALAG™ is the first therapeutic option containing a lymphocyte activation gene-3 (LAG-3)-blocking antibody to demonstrate statistically significant benefit in a Phase 3 clinical trial. In the RELATIVITY-047 phase 3 clinical trial OPDUALAG™ met its sole primary endpoint of progression free survival (PFS), with a more than doubling of its median when compared to nivolumab monotherapy, a current established standard of care.

“As a melanoma survivor, I personally understand the importance of access to treatments such as OPDUALAG™,” said Kathleen Barnard, Founder, Save Your Skin Foundation. “Today, I am pleased to know that patients like me, in Quebec, will now have access to this first-in-class treatment that truly should be accessible to patients across the country.”

“This announcement is critical for patients with unresectable or metastatic melanoma living in Quebec,” said Falyn Katz, CEO, Melanoma Canada. “Melanoma and skin cancer can impact all Canadians and that is why we urge all provincial and territorial drug plans to provide access to new treatment options for all Canadians who could benefit from them.”

Quebec is the first province in Canada to list OPDUALAG™ on its public drug plan. The listing is further to the recommendation for public reimbursement of OPDUALAG™ from the Institut national d’excellence en santé et en services sociaux (INESSS), supported by the results of the phase 3 RELATIVITY-047 trial.[5] Earlier this year, Canada’s Drug Agency (formerly CADTH) also recommended public reimbursement for OPDUALAG™.[6]

“We have made great progress over the past decade with a robust development program in oncology, built upon a legacy of leadership in innovative approaches, including bringing the first immune checkpoint inhibitor to patients. Today, we’re thankful for the decision by the Quebec government to include OPDUALAG™ to their public formulary,” said Elaine Phillips, General Manager, BMS Canada. “We are committed to helping appropriate patients initiate and maintain access to our medications during the treatment journey and will continue to collaborate with decision makers to ensure equitable access to OPDUALAG™ for all eligible Canadians.”

For more information about OPDUALAG™, including prescribing and safety information, please consult the Canadian Product Monograph here.

About Melanoma

Melanoma is one of the fastest growing cancers worldwide. In Canada, diagnosed cases of melanoma have more than tripled in the last 30 years and continue to rise. In fact, over 1,300 Canadians die from this disease each year.[7]

Melanoma begins as a malignant tumor in the melanocytes, which are the cells that produce melanin or pigment. As a malignant cancer, melanoma can metastasize to other parts of the body. There are several subtypes of melanoma, including cutaneous, acral, mucosal, ocular melanoma, and even amelanotic melanoma.[8]

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 close to 300 people across the country. For more information, please visit 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.

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For media requests please contact:

Daphne Weatherby
Corporate Affairs
Bristol Myers Squibb Canada

daphne.weatherby@bms.com

_{[1] Ibid.   ‌}

_{[2] List of medications | Régie de l’assurance maladie du Québec (RAMQ). Gouv.qc.ca. Published 2024. www.ramq.gouv.qc.ca/sites/default/files/documents/non_indexes/liste_med_etab_2024-09-26_fr.pdf}

_{[3] Skin cancer - Canada.ca. Canada.ca. Published 2016. www.canada.ca/en/public-health/services/sun-safety/skin-cancer.html}

_{[4] Skin cancer - Canada.ca. Canada.ca. Published 2016. www.canada.ca/en/public-health/services/sun-safety/skin-cancer.html}

_{[5] Opdualag (mélanome). INESSS. Published 2024. www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/extract-notice-to-the-minister/opdualag-melanome-6789.html}

_{[6] Canada’s Drug Agency Reimbursement Recommendation. Published February 2024. www.cda-amc.ca/sites/default/files/DRR/2024/PC0329REC-Opdaulag.pdf}

_{[7] Melanoma - Melanoma Canada. Melanoma Canada. Published July 24, 2024. www.melanomacanada.ca/understanding-skin-cancer/melanoma}   

_{[8] Melanoma | Save Your Skin. Save Your Skin. Published 2014. www.saveyourskin.ca/melanoma}