Long-term data boosts the efficacy of Bristol-Myers Squibb’s checkpoint inhibitor, Opdivo, as a treatment for renal cell carcinoma.
Long-term data boosts the efficacy of Bristol-Myers Squibb’s checkpoint inhibitor, Opdivo, as a treatment for renal cell carcinoma (RCC). Over the weekend, the company released follow-up results from two studies that support the survival benefits of patients treated with the medication.
At the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco, BMS presented long-term data from the CheckMate-214 and CheckMate-025 studies in advanced or metastatic renal cell carcinoma that showed the “durable, long-term survival benefits for Opdivo (nivolumab) with or without Yervoy (ipilimumab) across first and second-line treatment settings.”
In the CheckMate-025 study, BMS released five-year follow-up results that showed treatment with Opdivo continues to deliver “superior overall survival (OS) and objective response rates (ORR)” in patients with previously treated advanced or metastatic renal cell carcinoma compared to those treated with Novartis’ Afnitor (everolimus). The five-year data showed that patients treated with Opdivo continue to demonstrate OS benefit with 26% of patients alive compared to 18% of patients treated with everolimus, the company said during its presentation. Additionally, the percentage of patients experiencing an objective response was 23% for Opdivo versus 4% for everolimus.
When it came to the median duration of response (mDOR), the CheckMate-025 data showed that patients treated with Opdivo maintained their response longer than those on the Novartis medication, 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, BMS said.
Brian Lamon, development lead of genitourinary cancers at BMS, said the updated results from CheckMate-025 support the reason Opdivo as a standalone treatment “became a standard of care for previously treated RCC patients worldwide and offer additional evidence that treatment with Opdivo has the potential to help patients live longer.” He added that the study represents exciting progress in the company’s mission to improve survival outcomes for all patients.
Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.
In the CheckMate-214 follow-up, BMS said four-year data showed that those patients treated with a combination of Opdivo and Yervoy continued to yield superior overall survival (OS), objective response rates (ORR), duration of response and complete response rates compared to Pfizer’s Sutent (sunitinib) in patients with previously untreated advanced or metastatic RCC. The long-term data from CheckMate-214 showed that more than 50% of patients treated with Opdivo plus Yervoy were alive at 42 months compared to 39% of patients treated with sunitinib. The OS rate was 52% for patients treated with Opdivo and Yervoy compared to 39% for patients treated with sunitinib alone. The four-year data reinforces the depth and durability of response previously observed with the combination in the first-line patient population, BMS said.
The company said the complete response rates for the combination treatment were maintained and ongoing in more than 80% of the patients. Also, BMS said the four-year results from CheckMate-214 represent the longest follow-up “with any immuno-oncology-based therapy in this setting.”
The safety profile for the combination therapy remained consistent with previous studies.
Lamon said the findings from CheckMate-214 demonstrate the “complementary nature of dual immuno-therapy and reinforce the depth and durability of response the combination of Opdivo plus Yervoy can deliver for patients.”
