Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) Demonstrates Durable Long-Term Survival in First-Line Advanced Melanoma: 6.5-Year CheckMate-067 Data Show 49% Overall Survival Rate

May 23, 2021 /`Bio Valley`BIOON/ -- Bristol-Myers Squibb (BMS) recently announced 6.5-year data from the CheckMate-067 trial. This is a randomized, double-blind Phase 3Clinical Trial, in previously untreated advancedMelanomaconducted in patients to evaluate the efficacy and safety of the anti-PD-1 therapy Opdivo (generic name: nivolumab) in combination with the anti-CTLA-4 therapy Yervoy (generic name: ipilimumab), Opdivo monotherapy, and Yervoy monotherapy as first-line treatment.

6.5-year follow-up results demonstrate: Opdivo + Yervoy dual immunotherapy provides long-term survival benefits,49% of patients remained alive, with a median overall survival (OS) of 72.1 months., thisRepresents Phase IIIMelanomaLongest median OS in the trial。

Melanoma (Image source: healthjade.com)

Opdivo + Yervoy (OY combination) is the first and only dual immunotherapy to receive regulatory approval.. Opdivo + Yervoy is a unique combination of two immune checkpoint inhibitors with a potential synergistic mechanism of action, targeting two distinct checkpoints (PD-1 and CTLA-4) that work in a complementary manner to help the body destroyTumorcells. To date, the Opdivo + Yervoy combination therapy has been approved7 Therapeutic Indications for 6 Cancer Types（Melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma).

To date, the Opdivo + Yervoy combination therapy in6 Phase III TrialsClinical Trialshowed a significant improvement in overall survival (OS): Non-small cell lung cancer (CheckMate-227, CheckMate-9LA), metastaticMelanoma(CheckMate-067), advanced renal cell carcinoma (CheckMate-214), malignant pleural mesothelioma (CheckMate-743), esophageal squamous cell carcinoma (CheckMate-648).

The newly released CheckMate-067 trial data show that, with a minimum follow-up of 6.5 years, the median overall survival (OS) was 72.1 months (95% CI: 38.2 to not reached [NR]) in the Opdivo + Yervoy combination therapy group, 36.9 months (95% CI: 28.2 to 58.7) in the Opdivo monotherapy group, and 19.9 months (95% CI: 16.8 to 24.6) in the Yervoy monotherapy group; the 6.5-year OS rates were 49%, 42%, and 23%, respectively. Additionally, the 6.5-year progression-free survival (PFS) rates were 34% for the Opdivo + Yervoy combination group, 29% for the Opdivo monotherapy group, and 7% for the Yervoy monotherapy group; the median PFS were 11.5 months, 6.9 months, and 2.9 months, respectively.

Among patients who were still alive and on follow-up, 77% (112/145) of patients in the Opdivo + Yervoy combination therapy group, 69% (84/122) in the Opdivo monotherapy group, and 43% (27/63) in the Yervoy monotherapy group had discontinued treatment and had not received any subsequent systemic therapy.

In all relevant subgroups, durable and sustained clinical benefits were observed with both Opdivo + Yervoy combination therapy and Opdivo monotherapy, including in subgroups of patients with BRAF-mutant tumors, BRAF-wild-type tumors, and baseline liver metastases. Specifically, the 6.5-year overall survival (OS) rates were: (1) in patients with BRAF-mutant tumors, 57% for the Opdivo + Yervoy combination group, 43% for the Opdivo monotherapy group, and 25% for the Yervoy monotherapy group; (2) BRAF wild-typeTumorAmong patients, the Opdivo + Yervoy combination therapy group was 46%, the Opdivo monotherapy group was 42%, and the Yervoy monotherapy group was 22%; (3) among patients with baseline liver metastases, the Opdivo + Yervoy combination therapy group was 38%, the Opdivo monotherapy group was 31%, and the Yervoy monotherapy group was 22%.

The median duration of response (DoR) had not been reached for patients in the Opdivo + Yervoy combination therapy group and the Opdivo monotherapy group, and was 19.2 months for the Yervoy monotherapy group.

CheckMate-067 6.5-Year Data

With a minimum follow-up of 6.5 years, the safety profile of the Opdivo plus Yervoy combination regimen was consistent with prior study results, with no new safety signals observed and no additional treatment-related deaths since the 5-year analysis. Grade 3/4 treatment-related adverse events (TRAEs) were reported in 59% of patients in the Opdivo plus Yervoy combination group, 24% in the Opdivo monotherapy group, and 28% in the Yervoy monotherapy group.

Immunology, Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer CenterTumorDepartment Chair Dr. Jedd D. Wolchok stated: “Opdivo-based therapy, particularly the combination of Opdivo and Yervoy, has demonstrated sustained overall survival and progression-free survival benefits, which have changed our perspective on long-term efficacy outcomes in patients with advanced melanoma. These new results from the CheckMate-067 trial confirm that the combination of Opdivo and Yervoy for the treatment of advancedMelanoma"sustained and durable benefits for patients."

Gina Fusaro, Head of Melanoma Research and Development at Bristol-Myers Squibb, said: "These results build upon our decade-long legacy in melanoma treatment, whenDiagnosisThe average life expectancy for patients with metastatic melanoma is approximately 6 months, with less than 10% of patients surviving beyond 5 years. Based on the longest follow-up of immunotherapy to date, Opdivo and Yervoy have consistently demonstrated that, for patients diagnosed with advancedMelanomapatients have durable, long-term survival benefits." (Bioon.com)

Original Source: Six-and-a-Half-Year Outcomes for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Continue to Demonstrate Durable Long-Term Survival Benefits in Patients with Advanced Melanoma