Bristol Myers Squibb Announces CheckMate-8HW Phase III Results: Opdivo Plus Yervoy Reduces Risk of Disease Progression or Death by 79% in First-Line MSI-H/dMMR Metastatic Colorectal Cancer

TheIIIThe initial data from the phase randomized controlled study showed that, compared with first-line chemotherapy,OpdivoUnitedYiwoCan improve progression-free survival in this patient population, with results showing significant statistical and clinical significance.

Opdivo in combination with Yervoy is the first to be compared with chemotherapy inMSI-H/dMMRPhenotypemCRCDual immunotherapy combination shows significant efficacy benefits in first-line treatment

The latest data of the study in 2024American Society of Clinical Oncology （ASCO) Gastrointestinal Oncology Symposium, and was highlighted as part of the official conference news coverage.

ShanghaiJanuary 22, 2024PR Newswire -- Bristol-Myers Squibb recently announced the results of the Phase III study CheckMate -8HW, which evaluatedOpdivo(Nivolumab) in combination withYiwo(Ipilimumab), compared with investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI regimen, with or without bevacizumab or cetuximab), for the first-line treatment of metastatic colorectal cancer (mCRC) with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) phenotype. According to blinded independent central review (BICR) assessment,OpdivoUnitedYiwoThe dual immunotherapy combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint—progression-free survival (PFS): for patients with mCRC confirmed by central laboratory testing to have MSI-H/dMMR phenotype, it reduced the risk of disease progression or death by 79% compared to chemotherapy (Hazard Ratio [HR]: 0.21; 95% Confidence Interval [CI]: 0.14-0.32; p<0.0001).

These latest data (Abstract #LBA768) were orally presented at 9:15 AM Pacific Time on Saturday, January 20, during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium and were highlighted as part of the official press program of the conference.

OpdivoUnitedYiwoThe PFS improvement in the group began to appear at about three months and continued throughout.OpdivoUnitedYiwoThe median PFS in the group has not yet been reached (95% CI: 38.4-NE), compared to 5.9 months (95% CI: 4.4-7.8) in the chemotherapy group. Consistent PFS benefits were observed across all pre-specified subgroups, including patients with KRAS or NRAS mutations, as well as those with baseline liver, lung, or peritoneal metastases.

OpdivoUnitedYiwoThe safety profile of the combination therapy was consistent with previously reported data, remained manageable under the established study protocol, and no new safety signals were identified.OpdivoUnitedYiwoIn the group, 23% of patients experienced grade 3/4 treatment-related adverse events (TRAEs), compared to 48% in the chemotherapy group.OpdivoUnitedYiwoThe proportion of patients who discontinued treatment due to any-grade TRAE was 17% in the group and 32% in the chemotherapy group.

"Patients with MSI-H/dMMR phenotype metastatic colorectal cancer typically derive limited benefit from chemotherapy."Director of Medical Oncology, Sorbonne University and Saint-Antoine Hospital, Paris, France, M.D.Thierry AndreRepresentation"In this trial, compared with chemotherapy, the combination of nivolumab and ipilimumab showed an impressive and sustained improvement in PFS starting from three months. These results demonstrate the significant efficacy of this combination, which is expected to change the clinical treatment practice for this patient population."

OpdivoUnitedYiwoIt is the first dual immunotherapy to demonstrate significant efficacy benefits compared to chemotherapy in the first-line treatment of MSI-H/dMMR phenotype mCRC.

"Through the entire CheckMate series of clinical development programs, Bristol-Myers Squibb has brought revolutionary breakthroughs to the field of cancer treatment, changing the survival expectations of cancer patients. And today, based on the data from the CheckMate -8HW study, we have further demonstratedOpdivoUnitedYiwoReduced the risk of disease progression or death by up to 79% unprecedentedly."Vice President of Bristol-Myers Squibb, Global Head of Gastrointestinal and Genitourinary Oncology Development Programs, M.D.Dana WalkerExpressed as,"These results build onOpdivoUnitedYiwoBuilding on the CheckMate -142 study, which demonstrated benefits for MSI-H/dMMR phenotype mCRC; this further underscores our commitment to exploring the potential of dual immunotherapy to help more patients in clinical need.

The CheckMate -8HW study is still ongoing to evaluate the second dual primary endpoint, which involves all treatment lines receivingOpdivoUnitedYiwoComparison of Treated PatientsOpdivoPFS in patients treated with single-agent therapy; secondary endpoints, including overall survival (OS), will also be assessed.

Bristol-Myers Squibb sincerely thanks the patients and researchers who participated in the CheckMate -8HW trial.

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