These data will be presented in two posters at the virtual
In a new analysis from the CheckMate -9ER trial (Abstract #308) with a median follow-up of two years (23.5 months), Cabometyx in combination with Opdivo continued to show superior progression-free survival (PFS), objective response rate (ORR) and overall survival (OS) versus sunitinib, with a low rate of treatment-related adverse events (TRAEs) leading to discontinuation.1 No new safety signals were identified with extended follow-up. Across the full study population, the combination doubled median PFS (17.0 months vs. 8.3 months, respectively; HR 0.52; 95% CI: 0.43 to 0.64), the trial's primary endpoint, compared to sunitinib. The ORR indicated that nearly twice as many patients responded to Cabometyx in combination with Opdivo vs. sunitinib (54.8% vs. 28.4) and the combination maintained improvements in OS, demonstrating a 34% reduction in the risk of death compared to sunitinib (HR: 0.66; 95% CI: 0.50 to 0.87). In an exploratory analysis, the combination was associated with a disease control rate (including complete response, partial response and stable disease) of 88.2% vs. 69.9% with sunitinib and a complete response rate of 9.3% compared to 4.3% with sunitinib. Among patients treated with Cabometyx in combination with Opdivo, 6.6% discontinued both agents due to TRAEs, 9.7% discontinued Opdivo only and 7.2% discontinued Cabometyx only.1
In an exploratory subgroup analysis of 75 patients with sarcomatoid features, the combination of Cabometyx with Opdivo showed benefit in this population typically associated with a poor prognosis, reducing the risk of death by 64% vs. sunitinib (HR 0.36; 95% CI: 0.17 to 0.79) and demonstrating both superior PFS (10.3 months vs. 4.2 months) and ORR (55.9% vs. 22.0%).1
'There is a continued need for new therapies that show benefit across subgroups of patients with advanced renal cell carcinoma,' said
In a second analysis from the CheckMate -9ER trial (Abstract #285) conducted with 18.1 months of median follow-up, patients treated with the combination of Cabometyx and Opdivo reported statistically significant health-related quality of life (HRQoL) benefits.2 Treatment with Cabometyx in combination with Opdivo was associated with a lower treatment burden, decreased the risk of confirmed deterioration in HRQoL and a reduction of disease-related symptoms compared to sunitinib. These exploratory outcomes were measured using Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), a quality of life tool specific to kidney cancer, and EQ-5D-3L instruments.2
'As the advances in treatments for kidney cancer transform outcomes for patients, the goals of therapy have expanded from increasing survival to improving quality of life,' said Dr.
Cabometyx in combination with Opdivo is under review with health authorities globally following the combination's approval for the first-line treatment of advanced RCC by the
'We're pleased to share these positive results at ASCO GU, building on the growing body of data for the use of Cabometyx in first- and second-line settings. These data further support the importance of research investigating outcomes which really matter to patients,' said Prof. Dr.
A further notable presentation at ASCO GU evaluated the use of Cabometyx versus other TKIs after CPI treatment in the real-world management of patients with metastatic renal cell carcinoma (mRCC) (Abstract #293).3
A retrospective observational cohort study evaluating outcomes associated with Cabometyx or other TKIs (axitinib, lenvatinib, pazopanib, sorafenib, sunitinib) in patients with mRCC following CPI treatment3
Findings from the study suggest that Cabometyx is an effective and well tolerated option, associated with a significantly higher response rate and a lower discontinuation rate versus other TKIs included in the study, after treatment with CPIs.3
About renal cell carcinoma
There are over 400,000 new cases of kidney cancer diagnosed worldwide each year.5 Of these, renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of cases.6,7 It is twice as common in men, and male patients account for over two thirds of deaths.5 If detected in the early stages, the five-year survival rate is high, but for patients with advanced or latestage metastatic RCC the survival rate is much lower, around 12%, with no identified cure for this disease.
About the CheckMate -9ER trial
CheckMate -9ER is an open-label, randomized, multi-national Phase III trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1 1%) were randomized to Cabometyx plus Opdivo (n = 323) versus sunitinib (n = 328). The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients. The trial is sponsored by
About Cabometyx (cabozantinib)
Cabometyx is currently approved in 54 countries, including in the
The detailed recommendations for the use of Cabometyx are described in the Summary of Product Characteristics (SmPC) and in the
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience, and Rare Diseases. Ipsen also has a well-established
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