On September 20, 2022, Junshi Biosciences announced that toripalimab injection (拓益), an anti-PD-1 monoclonal antibody independently developed by the company, had obtained approval from the National Medical Products Administration (NMPA) for a new indication: first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) mutation and negative anaplastic lymphoma kinase (ALK) status. This is the sixth indication of toripalimab approved in China, which will bring more treatment options for Chinese patients with advanced non-small cell lung cancer.
Basis for the Approval of the New Indication
The approval of this new indication is mainly based on the data results of the CHOICE-01 study (NCT03856411). CHOICE-01 is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial, with Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences serving as the principal investigator.
From April 2, 2019 to August 5, 2020, the CHOICE-01 study enrolled a total of 465 NSCLC patients at 63 centers across China. Among them, 245 non-squamous NSCLC patients were randomized 2:1 to receive toripalimab/placebo in combination with pemetrexed plus cisplatin/carboplatin. After disease progression, eligible subjects in the control group could receive crossover treatment with toripalimab monotherapy.
About Lung Cancer
Lung cancer is currently the second most commonly diagnosed cancer and the leading cause of cancer death worldwide, and it ranks first in both incidence and mortality in China. According to data released by the World Health Organization, lung cancer cases in China accounted for 17.9% (816,000) of new cancer cases and 23.8% (715,000) of cancer deaths in 2020.
NSCLC is the major subtype of lung cancer, accounting for approximately 85% of all cases, and non-squamous NSCLC makes up about 70% of NSCLC patients. Existing domestic and international studies have demonstrated that anti-PD-(L)1 monoclonal antibody monotherapy or combination with chemotherapy has become the new standard first-line treatment for advanced driver gene-negative NSCLC.
Toripalimab injection (拓益) is the first domestically developed PD-1-targeted monoclonal antibody approved for marketing in China. It has been supported by the National Science and Technology Major Project and won the China Patent Gold Award, the highest honor in China’s patent field.
Approval History of Toripalimab
To date, toripalimab has been evaluated in more than 30 company-sponsored clinical trials covering over 15 indications globally (including China, the United States, Southeast Asia, Europe and other regions). Ongoing or completed key registration clinical studies have assessed the safety and efficacy of toripalimab across multiple tumor types, including lung cancer, nasopharyngeal carcinoma, esophageal cancer, gastric cancer, bladder cancer, breast cancer, liver cancer, renal cancer and skin cancer.
Up to now, toripalimab has been approved for 6 indications in China:
Treatment of unresectable or metastatic melanoma with failure of prior systemic therapy (December 2018);
Treatment of recurrent/metastatic nasopharyngeal carcinoma with failure of at least two lines of prior systemic therapy (February 2021);
Treatment of locally advanced or metastatic urothelial carcinoma with progression within 12 months of neoadjuvant or adjuvant chemotherapy following platinum-containing chemotherapy failure (April 2021);
First-line treatment in combination with cisplatin and gemcitabine for locally recurrent or metastatic nasopharyngeal carcinoma (November 2021);
First-line treatment in combination with paclitaxel and cisplatin for unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (May 2022);
First-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable locally advanced or metastatic non-squamous NSCLC with negative EGFR mutation and negative ALK status (September 2022).
In December 2020, toripalimab was first included in the national medical insurance coverage through national medical insurance negotiation. Currently, 3 of its indications have been incorporated into the 2021 National Reimbursement Drug List. It is the only anti-PD-1 monoclonal antibody indicated for melanoma and nasopharyngeal carcinoma in the National Reimbursement Drug List.
