240P - Efficacy and safety of first-line combination therapy with ipilimumab + nivolumab for metastatic renal cell carcinoma in a single institution in Japan

Background

The efficacy of first-line combination immuno-oncology therapy (IO) with ipilimumab plus nivolumab in metastatic renal cell carcinoma was demonstrated in the international phase III randomized CheckMate-214 trial. We also realized that the prognosis of Inter/Poor risk metastatic renal cancer could be extended in real clinical practice.

Methods

At Juntendo Univ. Hosp., Ipilimumab plus Nivolumab was used as first-line combination therapy for total 30 patients, including 27 patients with real-world Inter/Poor risk metastatic renal cell carcinoma from Jan/2019 to Aug/2023 and 3 patients enrolled in the international phase III study CheckMate-214. Efficacy in overall survival and safety, mainly immune-related adverse events(irAE), were retrospectively analyzed.

Results

Median age was 63 years (27-79), 37% (11/30) had prior nephrectomy. The most common metastatic lesions were lung (60%), bone (47%), and lymph node (37%). Three cases of hemodialysis were also included. The IMDC risk classification was Favor: Inter: Poor =2: 18: 10 cases. Total 80% (24/30) of cases were able to complete 4 cycles of ipilimumab. The average duration of IO treatment was 15.8 months (2-63). And the average duration of response was 27.3 months (2-92). During the mean follow-up period of 26.5 months (2-94), 6 cases died from cancer and 2 deaths from other causes. Among the cancer death cases, 4 of 6 cases were non-clear cell RCC. Deferred cytoreductive nephrectomy (DCN) could be performed in 2 cases in which metastatic lesions were controlled by IO-combo therapy. DCN was also performed in one patient withdrawn due to irAE, and surgical complete response (CR) was obtained. A total of 23% (7/30) had irAEs that forced IO administration to be discontinued. For irAEs of endocrine disorders, such as adrenal insufficiency and diabetes type 1, IO treatment could be continued with appropriate hormone replacement.

Conclusions

IO-Combo treatment for metastatic RCC was performed effectively and safely in Japanese patients. Surgical CR may be achieved with DCN after IO combination therapy even in poor-risk patients, but there is a possibility that Ipilimumab plus Nivolumab treatment has weak efficacy for non-clear cell RCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.