INESSS Issues Positive Recommendation for the Reimbursement of Subcutaneous Nivolumab Across Solid Tumor Indications

The Institut national d'excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of subcutaneous nivolumab (Opdivo) across all Health Canada–authorized solid tumor indications where intravenous nivolumab (Opdivo) is currently reimbursed.1

This recommendation follows Health Canada’s approval of the subcutaneous formulation of nivolumab on May 28, 2025 for use as monotherapy or maintenance monotherapy following completion of nivolumab plus ipilimumab (Yervoy) therapy, and in combination with chemotherapy or TKIs, tailored to the specific disease setting.2 This decision is underpinned by findings from the phase 3 CheckMate-67T trial (NCT04810078), which demonstrated pharmacokinetic noninferiority and comparable efficacy outcomes between subcutaneous and intravenous formulations.

"The availability of a subcutaneous option like [subcutaneous nivolumab] across several tumor types introduces added flexibility in how we deliver immunotherapy," Normand Blais, MD, the director of the Hemostasis-Thrombosis Laboratory, a member of the department of Hematology, Transfusion Medicine, medical officer of the Interdisciplinary Thoracic Oncology Team at Centre hospitalier de l'Université de Montréal, as well as a full professor of medicine at Université de Montréal, in Canada, stated in a news release.1 "It presents an opportunity to adapt care pathways in ways that take into account both system-level demands and patient needs, an important balance as we continue to evolve cancer care."

For Which Tumor Types is Subcutaneous Nivolumab Currently Approved?

• Renal cell carcinoma
• Melanoma
• Non–small cell lung cancer
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer
• Esophageal carcinoma
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

What Was the Design of the CheckMate-67T Trial?

The open-label, multicenter, randomized, noninferiority trial enrolled adults aged at least 18 years with histologically confirmed advanced or metastatic clear cell RCC, with or without sarcomatoid features, who experienced intolerance or progression following prior therapy within 6 months of random assignment.3 Patients were checkpoint inhibitor–naive and allowed up to 2 prior lines of therapy. Eligibility also required a Karnofsky performance status at least 70.

Participants were randomly assigned to receive either subcutaneous nivolumab at a flat dose of 1200 mg coformulated with 20,000 units of hyaluronidase every 4 weeks, or IV nivolumab at 3 mg/kg every 2 weeks per dosing guidelines in place at study initiation. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 2 years of therapy, or death.

The primary objective of the study was to assess the noninferiority of subcutaneous vs IV nivolumab via population pharmacokinetics analysis. Objective response rate (ORR) was a key secondary end point.

What Were the Key Findings From CheckMate-67T?

Findings demonstrated that patients in the subcutaneous nivolumab arm (n = 248), achieved noninferior pharmacokinetic exposure compared with those reciving intravenous (IV) administration (n = 247).2 Specifically, the lower boundary of the 90% confidence interval (CI) for geometric mean ratios (GMRs) was not less than 0.8 for both average serum concentration over 28 days (Cavg28) and minimum concentration (Cmin) at steady state.3

The geometric mean ratios were 2.10 (90% CI, 2.00-2.20) and 1.77 (90% CI, 1.63-1.93), respectively.2 In the subcutaneous nivolumab arm (n = 248), the geometric mean Cavgd28 was 77.373 μg/ml (90% CI, 74.555-80.297) compared with 36.875 μg/ml (90% CI, 35.565-38.235) in the IV arm (n = 247). The geometric mean Cmin was 122.227 μg/ml (90% CI, 114.552-130.416) in the subcutaneous arm versus 68.901 μg/ml (90% CI, 64.676-73.402) in the IV arm.3

The ORR was 24% (95% CI, 19%-30%) in the subcutaneous nivolumab group compared with 18% (95% CI, 14%-24%) in the IV nivolumab group.

"This positive recommendation from INESSS is an important step toward expanding access to innovative treatment options for patients in Quebec," Elaine Phillips, general manager, Bristol Myers Squibb Canada, expressed in a news release.1 "The subcutaneous formulation of [nivolumab] reflects our ongoing commitment to delivering scientific innovation that respond to real-world needs. We look forward to continued work with healthcare partners across Canada to enable timely access to [subcutaneous nivolumab] —supporting sustainable care that meets both patient needs and the health care system."

References

1. New subcutaneous formulation of OPDIVO® receives positive INESSS recommendation for multiple tumour types. News Release. September 23, 2025. Accessed September 23, 2025. https://www.biospace.com/press-releases/new-subcutaneous-formulation-of-opdivo-receives-positive-inesss-recommendation-for-multiple-tumour-types
2. New subcutaneous formulation of opdivo approved in Canada for use across all authorized solid tumour indications. News release. Bristol Myers Squibb Canada. May 27, 2025. Accessed September 23, 2025. https://www.biospace.com/press-releases/new-subcutaneous-formulation-of-opdivo-approved-in-canada-for-use-across-all-authorized-solid-tumour-indications
3. Albiges L, Bourlon MT, Chacón M, et al. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. Published online September 15, 2024. doi:10.1016/j.annonc.2024.09.002