Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Superior Efficacy Over Sutent in First-Line RCC Treatment with 48% Five-Year Survival Rate

September 16, 2021 /BioonBIOON/ -- Bristol-Myers Squibb (BMS) recently at the 2020 European MedicalTumorpresented at the European Society for Medical Oncology (ESMO) Virtual CongressOpdivo (nivolumab) in Combination with Low-Dose Yervoy (ipilimumab) as First-Line Treatment for Advanced or Metastatic Renal Cell Carcinoma (RCC)Latest Results of the Phase III CheckMate-214 Study (5-Year Data）。Results show that the Opdivo plus Yervoy immunotherapy combination (OY combination) continues to demonstrate durable long-term survival benefits: in the overall study population, patients treated with the OY combination,Nearly half (48%) were still alive after 5 years.。

These updated results represent any Phase III trial of first-line immuno-combination therapy for RCC.Clinical Trialthe longest follow-up duration. After a median follow-up of 67.7 months, the data continue to demonstrate,In both the primary endpoint population (patients with intermediate- and high-risk [IP] prognostic factors) and the overall study population (all randomized patients, i.e., the intent-to-treat [ITT] population), the OY combination maintained superior overall survival (OS) and response benefits compared to the targeted anticancer drug Sutent (sutent, generic name: sunitinib).。

To date,In 5 typesTumorof the 6 Phase III trialsClinical TrialIn China, the Opdivo + Yervoy combination therapy has demonstrated significant improvement in overall survival (OS): advanced renal cell carcinoma, non-small cell lung cancer, metastaticMelanoma, malignant pleural mesothelioma, esophageal squamous cell carcinoma.

Dr. Nick Botwood, Vice President of Oncology Development at Bristol-Myers Squibb, stated: “Four years ago, we presented the initial results of the CheckMate-214 trial at ESMO, which helped change the standard of care for advanced renal cell carcinoma. Now, with the longest follow-up of any Phase 3 trial of an immunotherapy combination in this disease, we are seeing the true long-term survival benefit of Opdivo and Yervoy. These 5-year RCC study results complement our data from several other`Tumor`The evidence observed in this type, namely that an Opdivo + Yervoy-based combination therapy can play a unique role in transforming survival outcomes for cancer patients.”

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

——In the IP patient population (n=847)Results of the 67.7-month follow-up analysis showed that, compared with the Sutent group, patients in the OY group demonstrated significant improvements in the following endpoints: (1) OS: the median OS was 47.0 months in the OY group versus 26.6 months in the Sutent group (HR=0.68, 95% CI: 0.58–0.81); the 5-year survival rate was 43% in the OY group compared with 31% in the Sutent group. (2) ORR: the OY group showed a numerically higher rate (42% vs 27%). (3) CR: the rate was 11% in the OY group versus 2% in the Sutent group. (4) DOR: the median DOR was not reached in the OY group, compared with 19.7 months in the Sutent treatment group.

——In the ITT population (n=1096)Results from the 67.7-month follow-up analysis showed that, compared with the Sutent group, patients in the OY group demonstrated significant improvements in the following endpoints: (1) For OS, the median OS was 55.7 months in the OY group vs. 38.4 months in the Sutent group (HR = 0.72; 95% CI: 0.62–0.85); the 5-year survival rate was 48% in the OY group and 37% in the Sutent group. (2) For ORR, the rate was numerically higher in the OY group (39% vs. 22%). (3) For CR, the rate was 12% in the OY group vs. 3% in the Sutent group; a higher proportion of patients in the OY group achieved CR with no subsequent disease progression (9.6% vs. 2.4%). (4) For DOR, the median DOR had not been reached in the OY group, compared with 24.8 months in the Sutent treatment group.

—— Safety: In the study, the safety profile of the Opdivo + Yervoy combination immunotherapy was manageable with established treatment algorithms, and no new safety signals emerged during long-term follow-up.

CheckMate-214 Presented During ESMOClinical Trial5-year data also includesConditional Survival Analysis, this analysis estimates the probability that patients remain event-free (i.e., alive, progression-free, or in remission) over a period of time after reaching a treatment milestone.

Key results include: (1)Among patients who survived 3 years after initiating OY combination therapy, the probability of surviving the subsequent 2 years was 81%, compared to 72% among those receiving Sutent. (2)Among patients who remained progression-free after 3 years of Opdivo plus Yervoy combination therapy, the probability of remaining progression-free over the subsequent 2 years was 89%, compared with 57% for those receiving Sutent. (3)Among patients who achieved a response to OY combination therapy and maintained it for 3 years, there is an 89% probability of remaining in response over the next 2 years, compared to a 63% probability among patients receiving Sutent treatment.

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, with over 431,000 new cases and more than 179,000 deaths worldwide annually. The incidence of RCC in men is approximately twice that in women, with the highest rates observed in North America and Europe. Based on historical data, the 5-year survival rate for patients diagnosed with metastatic or advanced kidney cancer is only 13%.

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

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 destroy tumor cells. Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells recognizeTumor。Additionally, certain T cells stimulated by Yervoy also become memory T cells, which may lead to a long-term immune response.

As of now,The Opdivo + Yervoy combination therapy has been approved for 7 therapeutic indications across 6 types of cancer (Melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma), which varies across different countries and regions. Furthermore, the Opdivo + Yervoy combination therapy has already been evaluated in 6 Phase III trials across 5 cancer typesClinical Trialshowed 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). (Bioon.com)

Original Source:Five-Year Data from CheckMate -214 Show Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Longest Median Overall Survival Currently Reported in Phase 3 Trial of Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma