(Boursier.com) — Ipsen announced the results of analyzes from the Phase III CheckMate -9ER study over a two-year follow-up period (25.4 months minimum; median 32.9 months), which demonstrated sustained benefits in terms of survival and response rate (abstract #350), as well as an improvement in health-related quality of life (HRQoL) (abstract #323) for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) compared to sunitinib in the treatment in first line of advanced renal cell carcinoma (RCC).
These latest results will be the subject of two poster presentations at the American Society of Clinical Oncology Symposium on Genitourinary Cancers (ASCO GU), February 17-19, 2022.
Dr. Cristina Suárez, MD PhD, medical oncologist at Hospital de Vall d’Hebron in Barcelona (Spain), and one of the principal investigators of the Phase III CheckMate -9ER trial, said: “I am delighted the breadth of efficacy benefits demonstrated for Cabometyx in combination with Opdivo in the CheckMate -9ER trial.These new data illustrate the potential benefits we can offer patients with this advanced disease, including the possibility significantly reduce the risk of death and, for some patients, achieve a complete response, while preserving their quality of life.Over the past few years, we have seen a dramatic change in the treatment landscape for renal cell carcinoma , both first and second line. This is an exciting time for treating physicians in this field.”
Over a median follow-up period of 32.9 months (minimum 25.4 months), Cabometyx in combination with Opdivo continued to demonstrate clinical superiority for efficacy endpoints, in terms of overall survival (OS) , progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR), including increased complete response rates compared to sunitinib1. For median OS, a secondary endpoint, the combination of the two drugs demonstrated a clinically significant and sustained improvement (37.7 months versus 34.3 months), with a 30% reduction in the risk of death (hazard ratio [HR] : 0.70, Confidence interval [IC] 95%: 0.55 to 0.90) compared to sunitinib1. Benefits in terms of PFS, the primary endpoint of the study, were also supported: median PFS continued to double compared to sunitinib (16.6 months versus 8.3 months respectively; HR: 0.56 95% CI: 0.46 to 0.68). Additionally, Cabometyx in combination with Opdivo continued to demonstrate superior ORR and DCR benefits over extended follow-up compared to sunitinib (ORR of 55.7% vs. 28.4% and DCR of 88. 2% against 69.3%). Furthermore, among patients treated with Cabometyx in combination with Opdivo, 12.4% of them observed a complete response compared to 5.2% for sunitinib. In another exploratory analysis assessing the level of target lesion response by organ, a higher percentage of patients experienced tumor shrinkage benefits on Cabometyx in combination with Opdivo compared to sunitinib, for all organs evaluated (kidney, liver, lung, lymph node and bone).
The safety profile established in the CheckMate -9ER study was consistent with that previously observed for Cabometyx and Opdivo. 97.2% of patients treated with Cabometyx in combination with Opdivo experienced treatment-related adverse events (all grades), compared with 93.1% of patients treated with sunitinib1. Overall, 10.6% stopped Opdivo only, 9.1% stopped Cabometyx only, and 7.5% stopped Cabometyx and Opdivo (simultaneously or successively).
In a separate analysis, over a median follow-up period of 32.9 months, patients continued to see clinically meaningful HRQoL benefits on Cabometyx in combination with Opdivo compared to sunitinib2. These results were measured using the Functional Assessment of Cancer Therapy (FACT) Kidney Symptom Index 19 (FKSI-19) questionnaire, which assessed quality of life in the specific case of patients with kidney cancer, as well as than EQ-5D-3L instruments, which assessed quality of life more generally. HRQoL scores on these instruments increased or were maintained over time in patients treated with Cabometyx in combination with Opdivo, while decreasing scores were observed with sunitinib. Additionally, patients who received the combination treatment were 48% less likely to be noticeably bothered by treatment side effects than patients in the sunitinib group. This new data follows the publication of HRQoL data collected over the median follow-up period of life 23.5 months in The Lancet Oncology, January 12, 2022.