Junshi Biosciences, a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, is pleased to announce that the interim analysis of the RENOTORCH study (NCT04394975) has been completed with positive results.
This multi-center, randomized, open-label, active-controlled phase 3 clinical study evaluated toripalimab in combination with axitinib for the first-line treatment of patients with intermediate to high risk, unresectable or distant metastatic renal cell carcinoma (RCC).
The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of Progression Free Survival (PFS) has met the pre-defined efficacy boundary. Junshi Biosciences is now in the process of communicating with regulatory authorities regarding supplemental new drug application.
Renal cell carcinoma (RCC) is the third most common malignancy in the urinary system, and it accounts for 80%-90% of all cases. In 2022, it is estimated that 77,000 new cases of RCC and 46,000 deaths due to this disease will occur in China.
Distressing news for those diagnosed is that one-third of the patients had distant metastasis at the initial diagnosis, while 20%-50% of the patients with localized tumors developed metastasis after nephrectomy.
According to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), the median overall survival (“OS”) of patients with low, medium and high risk metastatic RCC receiving anti-vascular targeted treatment was 35.3, 16.6 and 5.4 months respectively, indicating the urgent need for new treatment options for those with medium and high risk advanced RCC.
In recent years, the combination of PD-(L)1 inhibitors and anti-vascular targeted drugs has gained much success as a first-line treatment of advanced RCC in many countries, replacing anti-vascular targeted drug monotherapy as the new standard. This combination not only leads to a remarkable improvement in patients’ progression-free survival, objective response rate and overall survival, but also has yet to be approved in China.
The RENOTORCH phase 3 clinical trial is making history as the first immunotherapy study for advanced renal cell carcinoma (RCC) ever conducted in China. The interim analysis of the study showed that the combination of toripalimab and axitinib is more effective than sunitinib monotherapy in reducing the risk of disease progression or death in patients with intermediate to high-risk unresectable or metastatic RCC.
Additionally, the combination therapy also improved secondary endpoints such as overall response rate (ORR). The safety profile of toripalimab was in line with known risks and no new safety signals were observed. Further details of the study results will be presented at an upcoming international academic conference.
The RENOTORCH study has been a great success thanks to the collective efforts of investigators, patients, R&D teams and many others. This milestone marks a major step forward for Junshi Biosciences as an innovative Chinese pharmaceutical company, providing a much-needed solution to the unmet medical needs of the nation.
The positive results of the study will help bridge the gap in renal cancer PD-(L)1 immunotherapy in China and provide new and effective combination immunotherapy options for domestic patients. We are dedicated to taking all the necessary steps to commercialize and bring this achievement to the public.
About RENOTORCH
The RENOTORCH study, launched in August 2020 and jointly led by Professor Jun GUO of the Peking University Cancer Hospital and Professor Yiran HUANG of Renji Hospital of Shanghai Jiao Tong University School of Medicine, is a groundbreaking multi-center, randomized phase 3 trial that hopes to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib monotherapy as a first-line treatment for intermediate to high-risk unresectable or metastatic RCC patients.
Of the 47 domestic centers participating, a total of 421 patients have been enrolled and randomized in a 1:1 ratio to receive either the toripalimab-axitinib or sunitinib combination therapy until disease progression or intolerable toxicity. The primary endpoint of the study is PFS as assessed by an Independent Radiographic Review Committee, while secondary endpoints include PFS as assessed by investigators, ORR, DOR, DCR, OS, and safety profile.
About Toripalimab
Toripalimab is a revolutionary anti-PD-1 monoclonal antibody that has the power to unleash the body’s own powerful immune system to combat cancer. By blocking PD-1 interactions with PD-L1 and PD-L2, it allows the immune system to recognize and attack cancerous cells, ultimately leading to their destruction. This cutting-edge technology has the potential to revolutionize the way cancer treatment is approached.
Junshi Biosciences has conducted a wide range of clinical studies worldwide to assess the safety and efficacy of toripalimab, a powerful immunotherapy drug. With more than forty company-sponsored clinical trials in fifteen different indications, Junshi has been at the forefront of cancer research.
These trials have been conducted in China, the United States, Southeast Asia, and European countries, and have focused on a variety of tumor types, including lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin cancers. Through this cutting-edge research, Junshi Biosciences is revolutionizing the fight against cancer.
In China, the revolutionary anti-PD-1 monoclonal antibody, toripalimab, was granted marketing approval as TUOYI® – the first of its kind to be approved domestically. With six approved indications, toripalimab is making waves in the healthcare industry for its potential to provide effective treatment for various conditions.
Unresectable or metastatic melanoma can be a daunting diagnosis to receive, especially after traditional treatments have failed to provide relief. Fortunately, there are still a variety of options available to those in this situation, helping to restore hope and providing the opportunity to fight back against the disease.
Patients with advanced nasopharyngeal carcinoma (NPC) who have experienced treatment failure with two or more prior systemic therapies now have new hope. A promising new treatment option is now available for those with recurrent or metastatic NPC.
Patients suffering from urothelial carcinoma that has not responded to traditional platinum-containing chemotherapy, or has progressed within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy, now have a new hope in the form of locally advanced or metastatic treatment options.
Cisplatin and gemcitabine have proven to be an effective first-line treatment for patients with locally recurrent or metastatic NPC. Now, a promising new combination therapy of these two drugs with a third agent is demonstrating remarkable success in treating this form of cancer.
Paclitaxel and cisplatin have been combined to create a powerful first-line treatment for patients with unresectable, locally advanced or recurrent ESCC, or distant metastatic ESCC. Let’s join forces to fight this cancer and see the positive results!
Pemetrexed and platinum are now being used as the first-line treatment for EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This combination treatment has been shown to be an effective and promising option for patients in need of quality care.
Toripalimab, the only anti-PD-1 monoclonal antibody, has been included in the National Reimbursement Drug List (NRDL) (2022 Edition) for the treatment of melanoma, along with the first three indications. This marks a significant milestone in the effort to improve access to life-saving treatments for this serious condition.
The United States Food and Drug Administration (FDA) is currently evaluating a Biologics License Application (BLA) for toripalimab in combination with gemcitabine/cisplatin for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
In recognition of the potential of this treatment, the FDA has granted Breakthrough Therapy designations for the first-line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC.
Moreover, the FDA has also awarded Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for treatments of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC). With these designations, the prospects of toripalimab becoming a viable treatment option for a variety of cancer types is closer than ever.
In December 2022 and February 2023, the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) accepted marketing authorization applications (MAA) for toripalimab in combination with cisplatin and gemcitabine for the treatment of locally recurrent or metastatic NPC, and toripalimab combined with paclitaxel and cisplatin for the treatment of unresectable locally advanced/recurrent or metastatic ESCC. This is the first time that these treatments are available as first-line therapies.
About Junshi Biosciences
Junshi Biosciences (HKEX: 1877; SSE: 688180), a pioneering biopharmaceutical company founded in December 2012, is committed to the discovery, development, and commercialization of groundbreaking therapeutics. With a robust R&D pipeline of over 50 drug candidates in five therapeutic focus areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases, Junshi Biosciences has already made a mark in the industry.
Notably, it was the first Chinese company to obtain marketing approval for an anti-PD-1 monoclonal antibody in China. Additionally, its anti-BTLA monoclonal antibody to treat various cancers was the first in the world to be approved for clinical trials by both the FDA and NMPA, and is now in Phase Ib/II trials in both China and the US. To top it off, its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.
In the face of the pandemic, Junshi Biosciences responded with a strong and immediate call to action, enlisting Chinese and international scientific research institutions and enterprises to develop a powerful arsenal of drug candidates to combat COVID-19. Junshi Biosciences stepped up to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D.
In 2021, JS016 (etesevimab) and VV116 (deuremidevir hydrobromide) were granted Emergency Use Authorizations (EUA) in over 15 countries and regions, and approved for marketing in China and Uzbekistan respectively. These programs are a testament to Junshi Biosciences’ commitment to innovation for disease control and prevention of the global pandemic.