Policy & Regulation
Updated CheckMate -025 Results Show 26% of Patients Treated with Opdivo are Alive at Five Years in Patients with Previously Treated Advanced or Metastatic Renal Cell Carcinoma
19 February 2020 - - US-based Bristol-Myers Squibb Company (NYSE: BMY) has released five-year follow-up results from the Phase 3 CheckMate -025 study, which continue to demonstrate that treatment with Opdivo (nivolumab) delivers superior overall survival and objective response rates in patients with previously treated advanced or metastatic renal cell carcinoma compared to those treated with everolimus, the company said.

The data will be presented on Saturday, February 15 at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco.

With an extended minimum follow-up of 64 months, patients treated with Opdivo continue to demonstrate OS benefit with 26% of patients alive compared to 18% of patients treated with everolimus.

Additionally, the percentage of patients experiencing an objective response was 23% for Opdivo versus 4% for everolimus and the median duration of response for Opdivo was also maintained longer than for everolimus (18.2 months vs. 14 months, respectively).

The overall safety profile was consistent with that observed in previously reported analyses from CheckMate -025 in patients with RCC. No new safety signals or drug-related deaths occurred with extended follow-up.

CheckMate -025 is an open-label, randomized Phase 3 study of Opdivo versus everolimus in patients with previously treated advanced renal cell carcinoma after prior anti-angiogenic therapy.

Patients (n=803) received either Opdivo (n=406) 3 mg/kg intravenously every two weeks or everolimus (n=397) 10 mg orally once daily until disease progression or unacceptable toxicity.

The primary endpoint of the study was overall survival. Secondary endpoints included objective response rate, progression-free survival, quality of life and safety.

With a minimum of five years of follow-up, the incidence and type of treatment-related adverse events were consistent with the primary analysis.

Treatment-related grade 3/4 AEs were experienced by 21% of patients in the Opdivo group and 37% in the everolimus group.

Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year.

RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe.

Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.
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