ESMO 2020 Cabometyx (cabozantinib) in Combination With Opdivo (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial

Nachrichtenquelle: Business Wire (engl.)
19.09.2020, 18:30  |  186   |   |   

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial, in which Cabometyx (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo (nivolumab) demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), in previously untreated advanced renal cell carcinoma (RCC).1

Cabometyx in combination with Opdivo reduced the risk of death by 40% versus sunitinib (HR: 0.60 [98.89% Confidence Interval [CI]: 0.40–0.89]; p= 0.0010; median OS not reached in either arm). In patients receiving Cabometyx in combination with Opdivo, median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months versus 8.3 months respectively (Hazard Ratio [HR]: 0.51 [95% CI 0.41–0.64], p < 0.0001).

In addition, Cabometyx in combination with Opdivo demonstrated a superior objective response rate, with twice as many patients responding compared to sunitinib (56% vs. 27%; p<0.0001), and 8% versus 5% achieved a complete response. Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months. Additionally, patients treated with the combination had a much lower rate of treatment discontinuation versus sunitinib (44.4% vs. 71.3%), and a significantly lower rate of treatment discontinuation due to disease progression versus sunitinib (27.8% vs. 48.1%). All these key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 subgroups.

“While we’ve seen considerable progress in the treatment of metastatic renal cell carcinoma, we must continue to research new options to help more patients achieve positive outcomes,” said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “The CheckMate -9ER data demonstrate meaningful efficacy benefits with nivolumab plus cabozantinib, which significantly improved overall survival and doubled progression-free survival and objective response rate with consistent effects observed across pre-specified subgroups. These results, along with a favorable tolerability profile and superior health-related quality of life, highlight this regimen’s potential importance among combinations of immunotherapies and tyrosine kinase inhibitors.”

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