Pfizer's Inlyta (Axitinib) Receives China's First and Only Approval for First-Line Targeted-Immunotherapy Combination in Advanced Renal Cell Carcinoma

China Finance and Economics News, April 25th: Pfizer announced today that its oral targeted drug Inlyta (axitinib tablets) has been approved by the National Medical Products Administration (NMPA) for first-line treatment in combination with toripalimab for patients with unresectable or metastatic renal cell carcinoma (RCC) at intermediate to high risk. This is also the first and only approved first-line targeted-immunotherapy combination treatment regimen in the field of RCC treatment in China.

Inlyta (Axitinib) is an orally administered, potent, and highly selective tyrosine kinase inhibitor that acts on vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, inhibiting tumor growth, angiogenesis, and tumor progression. The approval of this first-line indication is based on the pivotal Phase III clinical RENOTORCH study, the first in China to evaluate a combination of targeted therapy and immunotherapy for advanced renal cell carcinoma. The study was jointly led by Professor Jun Guo from Peking University Cancer Hospital and Professor Yiran Huang from Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. It not only fills a gap in renal cancer treatment research in China but also provides high-level evidence for the application of targeted-immunotherapy combinations in the Chinese population.

Based on the assessment results from the Independent Review Committee (IRC), after a median follow-up of 14.6 months, compared to the control group, treatment with Axitinib in combination with Toripalimab extended the median progression-free survival (mPFS) from 9.8 months to 18.0 months (HR=0.65, P=0.0028), reducing the risk of disease progression or death by 35%. The median overall survival (mOS) for the combination therapy group has not yet been reached, but the overall survival curve indicates that OS was significantly prolonged in the combination therapy group, with a 39% reduction in the risk of death (HR=0.61).

Jean-Christophe Pointeau, President of Pfizer China and Chairman of the RDPAC Executive Committee, stated that Inlyta is an important product for Pfizer in the field of renal cancer treatment and is already classified as a Class B drug in the National Reimbursement Drug List. The recent approval of the new indication for first-line targeted immunotherapy combination fills a current clinical gap in renal cancer treatment in China, offering patients more treatment options and survival benefits. "In line with the mission of 'bringing breakthrough innovations that change patients' lives,' Pfizer will continue to advance the research, development, and clinical application of innovative solutions for genitourinary tumors, addressing the treatment needs of patients at different stages of the disease while continuously improving accessibility and affordability, supporting the increase of the 5-year survival rate for renal cancer, and collaborating with all parties to overcome cancer!"

Renal cell carcinoma (RCC) is one of the most common malignant tumors in the urinary system. According to data released by the National Cancer Center on the disease burden of malignant tumors in China, there were approximately 73,700 new cases and about 24,000 deaths in China in 2022. Among global patients with kidney cancer, the number of confirmed cases and related deaths in China ranks first, posing a heavy burden. Renal cell carcinoma (RCC) accounts for approximately 90% of all renal malignancies. Due to the insidious symptoms of kidney cancer in its early stages, around 30% of patients are already at the locally advanced or metastatic stage at the time of initial diagnosis. Even among patients with localized disease who undergo nephrectomy, 20-50% still develop distant tumor metastasis within five years.

In the past two decades, targeted therapy has been the main systemic drug treatment for kidney cancer. However, compared with low-risk patients, the effect of anti-angiogenic targeted therapy on intermediate- and high-risk metastatic renal cell carcinoma (RCC) patients has been limited, especially for high-risk patients, whose median overall survival (OS) is only 5.4 months, making the need for new treatment options more urgent. In recent years, with the clinical application of targeted + immunotherapy combination treatments, the prognosis of patients with advanced kidney cancer has improved.

One of the principal investigators of the RENOTORCH study, Professor Guo Jun from Peking University Cancer Hospital, stated that the combination of axitinib with various immunotherapy drugs has become the international first-line standard treatment for advanced renal cell carcinoma. The recent approval of axitinib in combination with toripalimab marks a significant step forward in China’s exploration of targeted-immunotherapy combinations for advanced renal cell carcinoma. "The RENOTORCH study represents the first pioneering investigation in China to adopt a targeted-immunotherapy combination as a first-line treatment for patients with advanced renal cell carcinoma. It not only fills the data gap for the Chinese population but also provides scientific evidence and confidence for clinicians to introduce the combination of axitinib and toripalimab in treating these patients. According to the research data, this combination therapy significantly delays disease progression, substantially prolongs patient survival, and achieves broader clinical accessibility through medical insurance coverage, reducing the treatment burden while offering more hope to patients."

To date, the first-line treatment regimen of axitinib combined with toripalimab for patients with advanced renal cell carcinoma has been highly recommended by multiple authoritative guidelines both in China and internationally, including the "CSCO Renal Cancer Diagnosis and Treatment Guidelines 2024" and the 2024 edition of the "ESMO Renal Cell Carcinoma Guidelines."