Opdivo-Cabometyx Shows Continued Survival Benefits Over 2 Years of Follow-Up

Bristol Myers Squibb and Exelixis Inc have announced 2-year follow-up results from analyses of the phase 3 CheckMate -9ER trial, showing sustained survival and response rate benefits, as well as health-related quality of life (HRQoL) improvements with the combination ofnivolumab (Opdivo) and cabozantinib (Cabometyx) versus sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).

These updated results will be featured in 2 poster presentations at the American Society of Clinical Oncology 2022 Genitourinary Cancers Symposium from February 17 to February 19, 2022.

“The new data from CheckMate -9ER evaluating nivolumab and cabozantinib are significant for patients with first-line advanced renal cell carcinoma, as they provide further evidence of efficacy benefits, as well as favorable patient-reported quality of life outcomes with this combination,” Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, said in a statement. “As clinicians, we are constantly looking for therapies that can help more patients control their disease without reporting a detriment in their quality of life.”.

As part of the first poster, the presenter will discuss the final overall survival (OR) analysis and organ-specific target lesion assessments with a 2-year follow-up.

With the median follow-up time of the CheckMate -9ER trial, nivolumab in combination with cabozantinib showed superior complete response (CR), duration of response (DoR), objective response rates (ORR), OR, and progression-free survival (PFS), compared with sunitinib.

CR rates were more than double with 12.4% having a CR compared to 5.2% of those treated with sunitinib.

DoR responses were more durable with the combination at a mean of 23.1 months compared with 15.1 months with sunitinib.

ORR benefits were sustained, with nearly twice as many patients responding to Opdivo in combination with Cabometyx versus sunitinib, at 55.7% and 28.4%, respectfully.

For the final OS analysis, the combination treatment showed meaningful improvements with a mean of 37.7 months compared with 34.3 months with sunitinib. Additionally, it showed a 30% reduction in the risk of death compared with sunitinib.

The PFS benefits were maintained and doubled for the combination, at a mean of 16.6 months compared with 8.3 months with sunitinib.

Additionally, there were no new safety concerns that emerged with the 2-year follow up. About 97.2% of individuals treated with nivolumab and cabozantinib experienced a treatment-related adverse event (AE) of any grade compared with 93.1% of those treated with cabozantinib.

About 65% of those treated with the combination had a grade 3 or higher AE compared with 54.1% with sunitinib.

Furthermore, in an exploratory analysis of depth of response in target lesions by organ site, a higher percentage of individuals experienced any tumor shrinkage benefits with the combination compared with sunitinib across bone (85.2% versus 65%), kidney (89% versus 71.6%), liver (72.7% versus 53.8%), lymph node (88.4% versus 72.6%), and lung (90.5% versus 76%) target lesions.In the second poster, a separate analysis with a 32.9-month follow-up from the CheckMate -9ER trial will be presented.

Individuals continued to report clinically meaningful HRQoL benefits from the combination compared with sunitinib.

HRQoL scores improved or were maintained over time among individuals treated with the combination, while reduction scores were observed with sunitinib. Additionally, individuals who received the combination were 48% less likely to be notably bothered by treatment AEs than individuals in the sunitinib arm.

These outcomes were measured using EQ-5D-3L instruments and the Functional Assessment of Cancer Therapy Kidney Symptom Index-19, a quality-of-life tool specific to kidney cancer.

Reference

Opdivo (nivolumab) in combination with Carbometyx (cabozantinib) demonstrates continued survival benefits with over two years of follow-up in the CheckMate -9ER trial in first-line advanced renal cell carcinoma. Bristol Myers Squibb. News release. February 14, 2022. Accessed February 15, 2022. https://news.bms.com/news/details/2022/Opdivo-nivolumab-in-Combination-with-CABOMETYX-cabozantinib-Demonstrates-Continued-Survival-Benefits-with-Over-Two-Years-of-Follow-Up-in-the-CheckMate--9ER-Trial-in-First-Line-Advanced-Renal-Cell-Carcinoma/default.aspx