Four-Year Data Show Opdivo + Yervoy Combination Achieves Over 50% Survival Rate in First-Line Treatment of Advanced Renal Cell Carcinoma

Sep 18, 2020 13:44 CST Updated 13:44

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September 18, 2020 News /Bio ValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently at the 2020 European MedicalTumorThe latest results (4-year data) from the Phase III CheckMate-214 study evaluating first-line treatment with Opdivo (nivolumab) in combination with low-dose Yervoy (ipilimumab) for advanced or metastatic renal cell carcinoma (RCC) were presented at the European Society for Medical Oncology (ESMO) Virtual Congress. The data showed that, among patients receiving the Opdivo-Yervoy combination therapy across the overall study population,More than half remained alive after 4 years.

These updated results represent the longest follow-up duration for any first-line immune checkpoint inhibitor combination therapy in renal cell carcinoma (RCC). The data continue to demonstrate that the Opdivo plus Yervoy immunotherapy combination (OY combination) provides long-term survival benefits and durable responses as a first-line treatment, compared with the targeted anticancer drug Sutent (sunitinib). These sustained benefits were observed in both the primary patient population (patients with intermediate- and poor-risk [IP] prognostic factors) and the intent-to-treat (ITT) population (all randomized patients).

CheckMate-214 is a randomized, open-label study conducted in previously untreated (treatment-naïve) patients with advanced or metastatic renal cell carcinoma (RCC), evaluating the efficacy and safety of the combination therapy of Opdivo (3 mg/kg) plus low-dose Yervoy (1 mg/kg) (O3Y1) versus the standard first-line therapy Sutent (sunitinib) as first-line treatment. Four-year data demonstrate that, compared with Sutent, the OY combination continues to show superior overall survival (OS), objective response rate (ORR), duration of response (DOR), and complete response rate (CR).

—Results from a 48-month follow-up analysis in the IP patient population (n=847) showed:Compared with the Sutent group, patients in the OY group demonstrated significant improvements in the following endpoints: (1) For OS, the median OS was 48.1 months in the OY group versus 26.6 months in the Sutent group (HR=0.65, 95% CI: 0.54–0.78); the 4-year survival rate was 50.0% in the OY group compared to 35.8% in the Sutent group. (2) For ORR, the OY group showed a numerically higher rate (65% vs. 50%). (3) For CR, the rate was 10% in the OY group versus 1% in the Sutent group, consistent with the 42-month analysis. (4) For DOR, the median DOR was not reached in the OY group, whereas it was 19.7 months in the Sutent group.

—The results of the 48-month follow-up analysis conducted in the ITT patient population (n=1096) showed:Compared with the Sutent group, patients in the OY group demonstrated significant improvements in the following endpoints: (1) Overall Survival (OS): The median OS was not reached in the OY group, compared to 38.4 months in the Sutent group (HR=0.69; 95% CI: 0.59-0.81); the 4-year survival rate was 53.4% in the OY group versus 43.3% in the Sutent group. (2) Objective Response Rate (ORR): The OY group showed a numerically higher ORR (65% vs. 52%). (3) Complete Response (CR): The CR rate was 11% in the OY group compared to 3% in the Sutent group. (4) Duration of Response (DOR): The median DOR was not reached in the OY group, whereas it was 23.7 months in the Sutent group.

In the study, the safety profile of the Opdivo + Yervoy immunotherapy combination was consistent with previous findings, with no new safety signals or drug-related deaths observed during long-term follow-up.

Bristol-Myers SquibbTumorDr. Nick Botwood, Vice President of Development, stated, “The 4-year results from the CheckMate-214 study continue to demonstrate the complementarity of dual immunotherapy and reinforce the depth and durability of response in patients treated with the combination of Opdivo and Yervoy. Overall, these data provide further evidence of the value of unique and complementary dual checkpoint inhibition in the treatment of advanced cancer.”

Opdivo + Yervoy Combination: The First Immunotherapy for First-Line Treatment of Intermediate- and High-Risk RCCTumorStudy of Combination Therapy

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing more than 140,000 deaths worldwide each year. The incidence of RCC in men is approximately twice that in women, with the highest rates observed in North America and Europe. Globally, the 5-year survival rate for patients diagnosed with metastatic or advanced renal cancer is only 12.1%.

Opdivo and Yervoy are both cancer immunotherapies that leverage the body’s own immune system to combat tumors by targeting distinct regulatory components within the immune system; specifically, Opdivo targets and blocks the PD-1/PD-L1 pathway, while Yervoy targets and blocks CTLA-4.

In the United States and the European Union, the Opdivo + Yervoy immunotherapy combination was approved in April 2018 and January 2019, respectively, becoming the first immuno-oncology combination therapy (I-O/I-O combination) for first-line treatment of patients with intermediate- or high-risk renal cell carcinoma (RCC).

Opdivo + Yervoy is the only dual immunotherapy approved by the U.S. FDA, featuring a potential synergistic mechanism of action that targets two distinct immune checkpoints (PD-1 and CTLA-4) and works in a complementary manner. In terms of U.S. regulatory approval, the Opdivo + Yervoy combination therapy has been approved.Six therapeutic indications across five cancer types (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer).(Bioon.com)

Original Source: Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma