Health Canada Approves Dual Immunotherapy OPDIVO® Plus YERVOY® for Colorectal and Liver Cancers Français
unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), and
unresectable or advanced hepatocellular carcinoma (HCC) 1.
This dual immunotherapy regimen offers a new first-line treatment approach for two challenging gastrointestinal cancers, supported by two pivotal Phase 3 trials: CheckMate-8HW in CRC which demonstrated improvement in progression-free survival, and CheckMate-9DW in HCC which showed improvements in survival—each compared to existing standard therapies 1.
"Although we've seen progress, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer is clinically complex, particularly in the first-line setting where there remains an ongoing need for additional treatments," said Vancouver-based medical oncologist, Dr. Sharlene Gill. "The approval of OPDIVO ® plus YERVOY ®, supported by CheckMate-8HW, the largest phase 3 immunotherapy trial to date in this population, offers a well-studied and very clinically meaningful option for patients and clinicians treating this distinct molecular subtype of colorectal cancer."
Calgary-based medical oncologist, Dr. Hatim Karachiwala added,"For patients with unresectable or advanced hepatocellular carcinoma improving outcomes continues to be a critical priority. Data from CheckMate-9DW provides useful insights into how the OPDIVO ® plus YERVOY ® dual immunotherapy strategy might be considered as part of the initial treatment approach."
BMS introduced immunotherapy in Canada in 2012 with the approval of YERVOY ®, ushering in a new era of cancer treatment providing an important option for patients with advanced cancers. The 2016 approval of the first dual immunotherapy regimen—YERVOY ® plus OPDIVO ® —further expanded this foundation. These latest indications further expand the reach of the combination to include MSI-H/dMMR colorectal and liver cancer patients.
Immunotherapy Advances Welcomed by Patient Groups
"In a country where colorectal cancer remains one of the most commonly diagnosed cancers and a leading cause of cancer death for both men and women 2, this news represents a much-needed advancement," said Barry Dr. Stein, President and CEO, Colorectal Cancer Canada. "This dual immunotherapy approach provides eligible patients and their care teams with a new, clinically validated strategy to take action early in the treatment journey."
Filomena Servidio-Italiano, President and CEO, Colorectal Cancer Resource & Action Network (CCRAN), added, "These approvals mark important progress for both the colorectal and liver cancer communities. For those facing aggressive disease, time matters. Expanding access to first-line immunotherapy—particularly with combination strategies that enhance the immune system engagement—responds to an important unmet need."
"Making up approximately 75% all primary liver cancer cases 3, hepatocellular carcinoma has a significant impact on patients across the country," said Jennifer Nebesky, President and CEO, Liver Canada. "In 2024, liver cancer was projected to be diagnosed in 4,700 Canadians, with 3,700 deaths 4 —figures that speak to the need for continued progress in improving care. The approval of OPDIVO ® plus YERVOY ® as a first-line treatment provides renewed hope and a new path forward for patients and clinicians alike."
In the CheckMake-8HW trial, OPDIVO ® plus YERVOY ® reduced the risk of disease progression or death by 79% compared to chemotherapy in the first-line treatment of MSI-H/dMMR metastatic colorectal cancer. In advanced hepatocellular carcinoma, the CheckMate-9DW trial showed the combination delivered a statistically significant overall survival benefit compared to tyrosine kinase inhibitors. These results highlight the potential of dual immunotherapy to drive meaningful change in early treatment across both cancers.
"These approvals underscore our continued focus on advancing immunotherapy where it can make a meaningful difference," said Elaine Phillips, General Manager, Bristol Myers Squibb Canada. "By introducing OPDIVO ® plus YERVOY ® as a first-line treatment option for these two distinct and challenging gastrointestinal cancers, we are expanding access to a dual immunotherapy approach in areas with significant unmet need. This milestone reflects our commitment to delivering innovative science with real-world impact."
Clinical Trials Overview
OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), was evaluated in two pivotal Phase 3 trials—CheckMate-8HW and CheckMate-9DW—supporting its first-line use in MSI-H/dMMR colorectal and liver cancers.
CheckMate-8HW is a global, randomized, open-label Phase 3 trial that enrolled 839 patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). The trial included an evaluation of OPDIVO ® plus YERVOY ® (n=202) versus standard-of-care chemotherapy (with or without bevacizumab or cetuximab) (n=101). The OPDIVO ® plus YERVOY ® versus investigator's choice chemotherapy with/without bevacizumab or cetuximab arm of the trial showed that the combination regimen reduced the risk of cancer progression or death by 79% compared to chemotherapy in centrally confirmed MSI-H/dMMR mCRC first-line patients (HR 0.21; 95% CI: 0.14-0.32; P<0.0001). After a median follow-up of 31.5 months, median progression-free survival (PFS) was not reached with OPDIVO ® plus YERVOY ® (95% CI: 38.4-NE) compared to 5.9 months with chemotherapy (95% CI: 4.4-7.8). Kaplan-Meier curves showed early and sustained separation starting at three months, with PFS rates of 79% vs. 21% at 12 months and 72% vs. 14% at 24 months, respectively.
CheckMate-9DW is a global, randomized, open-label Phase 3 trial that enrolled 668 patients with unresectable or advanced hepatocellular carcinoma (HCC) who had not received prior systemic therapy. Patients were randomized to receive OPDIVO ® plus YERVOY ® (n=335) or investigator's choice of lenvatinib or sorafenib monotherapy (n = 333). The dual immunotherapy regimen consisted of OPDIVO ® 1 mg/kg plus YERVOY ® 3 mg/kg every three weeks for up to four doses, followed by OPDIVO ® monotherapy 480 mg every four weeks. The trial demonstrated a statistically significant improvement in overall survival (OS): median OS was 23.7 months with OPDIVO ® plus YERVOY ® versus 20.6 months with lenvatinib/sorafenib (HR 0.79; 95% CI: 0.65–0.96; p = 0.0180). The overall response rate (ORR) was 36.1% vs. 13.2% (p < 0.0001), with complete responses in 6.9% of patients receiving dual immunotherapy. Median duration of response was 30.4 months vs.12.9 months.
In both trials, the safety profile of OPDIVO ® plus YERVOY ® was consistent with the known class effects of PD-1 and CTLA-4 inhibitors. Immune-mediated adverse events were generally manageable with established treatment algorithms.
For more information, including prescribing and safety information related to the new indications, please consult the Canadian product monograph for OPDIVO ® here.
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 https://www.bms.com/ca/en.
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SOURCE Bristol-Myers Squibb Canada
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