Pharma Focus Asia

Junshi Biosciences Gains Approval for sNDA of Toripalimab as First-Line Therapy for Small Cell Lung Cancer

Wednesday, June 19, 2024

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading biopharmaceutical company focused on developing innovative therapies, announced that the National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab (JS001). This approval is for its use in combination with etoposide and platinum as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

Lung cancer is the most common and deadliest form of cancer in China. Small cell lung cancer (SCLC) is a highly aggressive form, comprising 15%-20% of lung cancer cases, characterized by rapid growth, early metastasis, and poor prognosis. SCLC is categorized into limited-stage (LS-SCLC) and extensive-stage (ES-SCLC). While LS-SCLC can achieve high response rates and a five-year survival rate of about 25% with standard chemotherapy and radiotherapy, most patients present with ES-SCLC, which has a median survival of less than one year and a two-year survival rate below 10%, posing a significant clinical challenge.

The approval of this sNDA is based on results from the EXTENTORCH study (NCT04012606), a Phase 3 clinical trial that was randomized, double-blind, placebo-controlled, and multi-center. This study compared the efficacy and safety of toripalimab with a placebo, both in combination with etoposide and platinum, for first-line treatment of ES-SCLC. The study was led by Professor Ying CHENG from Jilin Cancer Hospital and involved 51 clinical centers across China.

In May 2023, the EXTENTORCH study met its primary endpoints, making toripalimab the first PD-1 inhibitor globally to achieve both overall survival (OS) and progression-free survival (PFS) primary endpoints in a Phase 3 study for first-line treatment of ES-SCLC.

At the European Society for Medical Oncology (ESMO) Congress in October 2023, EXTENTORCH data were presented, showing that toripalimab combined with chemotherapy significantly extended PFS and OS compared to chemotherapy alone, with a favorable safety profile. Specifically, the median PFS for the toripalimab group was 5.8 months, reducing the risk of disease progression or death by 33.3% (P=0.0002). The one-year PFS rate in the toripalimab group was almost four times higher (18.1% vs. 4.9%). The median OS for the toripalimab group was 14.6 months, reducing the risk of death by 20.2% (P=0.0327), with a one-year OS rate of 63.1%.

"SCLC is highly invasive, metastasizes early, and has a poor prognosis. Standard treatment for ES-SCLC has long been platinum-based chemotherapy, but patients often develop resistance," said Professor Ying CHENG. "The EXTENTORCH study's dual primary endpoints of PFS and OS were met with higher statistical standards, showing that toripalimab combined with chemotherapy significantly improves outcomes compared to chemotherapy alone. This approval provides a new, effective, safe, and affordable treatment option for SCLC patients in China."

"Lung cancer, with the highest incidence and mortality rates, remains a major challenge," said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences. "Junshi Biosciences has consistently invested in lung cancer research, with three approved indications covering major subtypes and stages of lung cancer. More products and indications are in development to provide better treatment options for lung cancer patients."

Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with PD-L1 and PD-L2, enhancing the immune system's ability to target and kill tumor cells.

Junshi Biosciences has conducted over forty clinical studies globally, including in China, the US, Southeast Asia, and Europe, for toripalimab, covering more than fifteen indications. Pivotal trials have evaluated its safety and efficacy across various cancers, including lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin cancers.

In the US, the FDA approved toripalimab in combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent locally advanced NPC, and as a single agent for recurrent, unresectable, or metastatic NPC after platinum-containing chemotherapy in October 2023. The FDA granted toripalimab 2 Breakthrough Therapy designations for NPC treatment, 1 Fast Track designation for mucosal melanoma, and 5 Orphan Drug designations for esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC.

In Europe, the EMA and MHRA accepted marketing authorization applications (MAA) for toripalimab combined with cisplatin and gemcitabine for first-line treatment of locally recurrent or metastatic NPC, and combined with paclitaxel and cisplatin for first-line treatment of unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

In Australia, the Therapeutic Goods Administration (TGA) accepted the new chemical entity (NCE) application in November 2023 and granted Orphan Drug designation for NPC treatment.

In Singapore, the Health Sciences Authority (HSA) accepted the NDA in January 2024 and granted priority review designation for the application.



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