Among the news that oncologists arriving in San Francisco to participate in the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) from 16 to 18 February 2023 they will find there is one that concerns patients with advanced renal cell carcinoma. Three-year data from a phase III survival study of cabozantinib plus nivolumab will be presented. These are data from the longest follow-up for this patient population.
Renal cell carcinoma
Renal cell carcinoma is the most common type of kidney cancer, accounting for about 90% of cases. It is twice as common in men, and male patients account for more than two-thirds of deaths. If diagnosed early, the five-year survival rate is high, but in patients with late-stage advanced or metastatic cancer, the survival rate is much lower, about 12%, and there is currently no cure. In Italy, in 2022, around 12,600 new diagnoses were estimated (men = 7,800; women = 4,800). In about 25-30% it occurs in the loco-regionally advanced and/or metastatic phase and, in about 25-30% of cases, the disease recurs after surgery with curative intent.
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Lo studio CheckMate-9ER
Follow-up data to be presented tomorrow in San Francisco is from CheckMate-9ER is an open-label, randomized, multicenter, Phase III study evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1 ≥ 1%) were randomized to receive cabozantinib plus nivolumab (n = 323) versus sunitinib ( n = 328). The primary efficacy analysis compared the dual combination versus sunitinib in all randomized patients. The study is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and is co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.
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Three-year follow-up data
Updated results from the CheckMate-9ER study showed that nivolumab in combination with cabozantinib durably prolongs survival and maintains response benefits compared to sunitinib for more than three years, regardless of patient risk classification. These results confirm the importance of this immunotherapy and tyrosine kinase inhibitor regimen for patients and open new perspectives on their survival expectations. In fact, in the CheckMate-9ER study, the overall survival benefits were maintained over a three-year follow-up.
Survival lengthens
Median overall survival was significantly longer in patients treated with cabozantinib in combination with nivolumab than sunitinib, 49.5 months compared with 35.5 months, demonstrating a 30% reduction in the risk of death. Furthermore, median survival improved by 11.8 months from the previous cut-off date to 32.9 months of median follow-up. “Updated data from the CheckMate-9ER study, after more extensive follow-up, show that the combination of cabozantinib and nivolumab is capable of achieving a median overall survival (OS) of 49.5 months. It is a fact that represents a success in the treatment of this neoplasm by outlining a path that aspires to its chronicization that does not leave the scientific community indifferent “, he commented Roberto Iacovelli, Associate Professor of Medical Oncology at the Agostino Gemelli IRCCS University Hospital Foundation in Rome. “In Italy, in 2022 alone, kidney cancer was diagnosed in over 12,000 new patients; among these, 25-30% are candidates to start medical treatment immediately due to the presence of metastases at the time of diagnosis and another 25-30% due to their appearance during follow-up after removal of the primary tumor with curative intent. Both of these types of patients can now benefit from the combination of cabozantinib and nivolumab and therefore aspire to long survival as well as preservation of quality of life and the favorable toxicity profile already known for this combination”.
Disease-free survival also improved
Patients treated with cabozantinib in combination with nivolumab also had benefits in terms of progression-free survival (PFS) and objective response rate (ORR; reduction in tumor size with treatments) compared to those treated with sunitinib.. Notably, progression-free survival with cabozantinib in combination with nivolumab nearly doubled to 16.6 months compared with 8.4 months with sunitinib. Objective response rate (ORR) doubled with cabozantinib in combination with nivolumab compared to sunitinib. Responses were also more durable with the combination, with a median duration of response (DoR) of 23.1 months compared with 15.2 months with sunitinib.
The other studies at Asco Genitourinary
Six additional abstracts confirming the benefits of cabozantinib in advanced renal cell carcinoma (aRCC) and non-clear cell renal cell carcinoma (nccRCC) will be presented during Asco GU. Among them, the CaboCombo, a prospective, international, non-interventional study of cabozantinib plus nivolumab in the first-line treatment of patients with aRCC. The study will collect real-world evidence from the first-line use of cabozantinib plus nivolumab. Cohort 10 of COSMIC-021 study evaluating cabozantinib in combination with atezolizumab in nccRCC, and further investigates the potential of cabozantinib in combination with immune checkpoint inhibitors. Finally, a biomarker analysis from the CheckMate-9ER study shows that, at the median 44-month follow-up, median PFS and OS improved with cabozantinib plus nivolumab compared with sunitinib, regardless of PD-L1 status. “Our goal is to enable people living with cancer to live longer and better lives, and these findings reinforce the value that cabozantinib can offer patients with advanced renal cell carcinoma when used in combination with immunotherapy. in the frontline setting,” he says Steven Hildemann, MD PhD, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Global Patient Safety. “We sincerely thank the patients who participated in the study, their families and the scientific community.”