In the phase 3 RENOTORCH trial, frontline toripalimab plus axitinib appears to improve the overall response rate of patients with unresectable or metastatic renal cell carcinoma.
The frontline use of toripalimab (Tuoyi) in combination with axitinib (Inlyta) to treat patients with advanced renal cell carcinoma (RCC) has proven efficacious and met the primary end point of progression-free survival (PFS) in the phase 3 RENOTORCH trial (NCT04394975), according to a press release from Shanghai Junshi Biosciences.
These results came from a prespecified interim analysis, which found that the toripalimab regimen yielded a significant reduction in the risk of disease progression or death compared with sunitinib (Sutent) monotherapy. The Independent Data Monitoring Committee (IDMC) thus determined that the primary end point of PFS had met its predefined efficacy boundary.
Toripalimab also produced an improved overall response rate (ORR), a secondary end point. The safety profile of the agent was consistent with its known risks; no new safety signals were identified. Investigators will release detailed findings from the study at a future international medical conference.
“Thanks to the collective efforts of the investigators, patients, [research and development] teams and many others, the RENOTORCH study has been a great success,” Jianjun Zou, MD, president of global research and development at Junshi Biosciences, said in the press release. “We believe that RENOTORCH’s positive results will help bridge the gap in renal cancer PD-L1 immunotherapy in China, and we will take all the necessary steps to commercialize this achievement and provide new and effective combination immunotherapy options for domestic patients.”
Toripalimab is an anti-PD-1 monoclonal antibody designed to impede the interactions between PD-1 and its ligands, PD-L1 and PD-L2, which promotes the immune system’s ability to eliminate tumor cells. The agent is also designed to enhance receptor internalization.
The multicenter, randomized, open-label phase 3 RENOTORCH study enrolled 421 patients across 47 Chinese medical centers. This study population consisted of patients with intermediate- to high-risk unresectable or metastatic RCC.
The trial randomly assigned patients 1:1 to receive 240 mg of toripalimab intravenously every 3 weeks in combination with 5 mg of axitinib orally twice a day or 50 mg of sunitinib orally once a day until disease progression or unacceptable toxicity.
The primary end point was PFS as assessed by an Independent Radiographic Review Committee (IRC). Secondary end points included investigator-assessed PFS, IRC- or investigator-assessed ORR, duration of response, disease control rate, overall survival, and toxicity.
To be eligible for inclusion, patients must have received no prior systemic therapy after previous metastasis for RCC. An ECOG performance status of 0 or 1, along with adequate bone marrow, renal, hepatic, endocrine, and coagulation function, were among the other inclusion criteria.
Exclusion criteria included any prior treatment with agents targeting PD-1, PD-L1, or CTLA-4, as well as any prior systemic anti-cancer therapy following metastasis. Patients were also excluded if they experienced progression or recurrence either during adjuvant or neoadjuvant therapy for RCC within 12 months after the last dose of treatment. Another exclusion criterion was any additional malignancy that had progressed or necessitated treatment in the 5 years prior to randomization, with the exceptions of basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ for which the patient has received potentially curative therapy.
Junshi Biosciences announces primary endpoint met in RENOTORCH study of toripalimab for 1st-line treatment of advanced renal cell carcinoma. News Release. Shanghai Junshi Biosciences Co., Ltd. April 27, 2023. Accessed April 27, 2023. https://bit.ly/3oRVtEP