Editor's Note: Kidney cancer is one of the three major tumors of the urinary system. According to statistics, in 2022, there were approximately 77,000 new cases and 46,000 deaths from kidney cancer in China. The prognosis for advanced metastatic kidney cancer is poor, with a five-year overall survival rate of less than 20% with targeted therapy alone. As research progresses both domestically and internationally, the treatment of advanced kidney cancer is continuously improving. At this year’s Annual Progress Seminar of Chinese Clinical Oncology (BOC) and Best of ASCO 2024 China (BOC/BOA 2024) held in Guangzhou, Oncology Frontier invited Professor Pei Dong from Sun Yat-sen University Cancer Center to share insights on the unmet needs for advanced kidney cancer in China, the latest treatment advancements both domestically and internationally, and the future changes in clinical practice.

Current Status and Unmet Needs in Advanced Kidney Cancer in China

Oncology Frontier: Could you describe the current status of diagnosis and treatment for advanced kidney cancer in China and the unmet needs of patients based on clinical practice?

Professor Pei Dong: With the publication of the RENOTORCH study results, we have officially entered the era of combined targeted and immune therapy for advanced kidney cancer in China. The study results showed that axitinib combined with toripalimab significantly improved PFS (18.0 months vs. 9.8 months; P=0.0028) and OS (NE vs. 26.8 months) in patients with advanced intermediate- to high-risk kidney cancer and significantly reduced the risk of progression by 35%. This confirms that combining a domestic immune checkpoint inhibitor with targeted therapy can achieve good efficacy. This treatment regimen has been approved by the National Medical Products Administration (NMPA) for first-line treatment of intermediate- to high-risk unresectable or metastatic renal cell carcinoma. However, despite this approval, PD-1 monoclonal antibody toripalimab for kidney cancer treatment is not currently covered by insurance. This means that patients cannot benefit from insurance when this regimen is needed in clinical practice, which is one of the unmet clinical needs.

Recent Breakthroughs by Professor Pei Dong’s Team

Oncology Frontier: To further improve clinical practice, kidney cancer experts in China have conducted numerous studies. What recent breakthroughs have you and your team achieved?

Professor Pei Dong: Our team presented three clinical studies at this year’s ASCO annual meeting, which were displayed as posters. Although these clinical trials are small-sample studies, we hope to address specific issues encountered in clinical practice through these studies. The first study involved anlotinib combined with sintilimab as first-line treatment for advanced non-clear cell renal cell carcinoma (nccRCC) patients. The results showed an ORR of 52.9% (95% CI: 0.35-0.70) and a median PFS of 15.1 months (95% CI: 13.2-16.9), indicating good efficacy for this rare type of kidney cancer.

Secondly, while international guidelines typically recommend combined targeted and immune therapy or immune checkpoint inhibitor-based strategies for first-line treatment of kidney cancer, many patients in China still receive targeted monotherapy as first-line treatment. For these patients, the optimal subsequent treatment strategy—whether to switch to combined immunotherapy or continue with targeted therapy combined with other treatments—is unclear due to a lack of robust evidence. To address this, our team used camrelizumab plus apatinib to treat patients with advanced renal cell carcinoma who had progressed on first-line tyrosine kinase inhibitor therapy. The results showed an ORR of 34.3% (95% CI: 19.1-52.2) and a median PFS of 10.0 months (95% CI: 6.1-14.9). The study is ongoing, with the aim of providing longer-term benefits for patients.

The third study analyzed individualized treatment for patients with oligoprogressive disease. Kidney cancer patients may develop resistance due to disease progression, but oligoprogressive patients exhibit progression in only a few lesions without widespread disease progression. This study used first-line treatment combined with stereotactic body radiotherapy (SBRT) for local lesions. The results showed an overall local control rate of 97.1%, with an additional 4-5 months of remission time for patients, significantly extending the duration of first-line systemic therapy and improving patients’ quality of life.

Efficacy and Safety of Avelumab Plus Axitinib in Advanced Kidney Cancer

Oncology Frontier: Previous studies have shown that avelumab combined with axitinib can improve PFS in advanced kidney cancer. This year’s ASCO conference also presented the final OS results. Could you share the efficacy and safety of this regimen?

Professor Pei Dong: The JAVELIN Renal 101 study using avelumab combined with axitinib has been closely followed by kidney cancer researchers. This year’s ASCO conference presented over 68 months of long-term follow-up data. Unfortunately, the overall OS did not significantly surpass that of the control group, showing positive results only in high-risk kidney cancer patients, with no significant differences in other treatment groups. This suggests that the efficacy of PD-L1 inhibitors compared to PD-1 inhibitors in advanced kidney cancer requires further attention. The study also presented long-term follow-up safety data, confirming that this combination regimen did not show new safety issues during long-term follow-up, demonstrating good tolerability.

Implications of These Advances for Advanced Kidney Cancer Patients and Future Clinical Practice

Oncology Frontier: What do these advancements mean for advanced kidney cancer patients, and how will they impact future clinical practice?

Professor Pei Dong: We have always advocated for individualized and multidisciplinary whole-process management in the treatment of advanced kidney cancer. For Chinese kidney cancer patients, we particularly advocate stratified treatment: low-risk patients typically start with targeted monotherapy, while intermediate- to high-risk patients, especially high-risk patients, should prioritize combined targeted and immune therapy. Based on this, second-line treatment strategies should become more diverse. For patients who progress after first-line targeted therapy, we might recommend second-line combined targeted and immune therapy. For oligoprogressive or oligometastatic patients, we recommend combining local treatments, such as surgical resection or radiotherapy or ablation of local lesions, to improve overall efficacy.

Professor Pei Dong

• Chief Professor for Kidney Cancer
• Associate Chief Physician, Master’s Supervisor
• Joint Ph.D. program with Central South University and Harvard University
• Chief Professor at Sun Yat-sen University Cancer Center
• Deputy Leader of the Rare Kidney Cancer Collaboration Group of the Urological and Male Reproductive System Tumors Committee of the Chinese Anti-Cancer Association
• Secretary and Editorial Board Member of the CSCO Kidney Cancer Diagnosis and Treatment Guidelines (2022-2023)
• Standing Committee Member of the Youth Committee of the Chinese Society of Clinical Oncology (CSCO)
• Standing Committee Member of the Integrative Medicine Kidney Cancer Committee of the Chinese Anti-Cancer Association
• Deputy Director of the Immunotherapy Branch of the Guangdong Provincial Health Association
• Member of the CSCO Kidney Cancer Committee
• Member of the Urological and Male Reproductive System Committee of the Guangdong Anti-Cancer Association
• Member of the Urological Oncology Group of the Guangdong Medical Association Urology Branch
• Member of the Urological Oncology Branch of the Guangdong Urology and Reproductive Association
• Editorial Board Member of the Chinese editions of JCO and CA
• Recipient of the Yangcheng Good Physician and the Golden Camellia Award – China Good Physician
• Outstanding Physician in the Chinese Urology MDT
• Expert in comprehensive treatment of urological tumors, whole-process management of kidney cancer, minimally invasive nephron-sparing treatment of complex kidney tumors, surgery and postoperative adjuvant treatment of high-risk kidney cancer, individualized multidisciplinary comprehensive treatment of advanced metastatic kidney cancer, and surgical treatment of complex retroperitoneal masses