Shanghai Junshi Biosciences , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab (product code: JS001) in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

Lung cancer is currently the most prevalent malignant tumor with the highest mortality rate in China. Small cell lung cancer (SCLC) is the most aggressive subtype of lung cancer, accounting for approximately 15%-20% of all lung cancer cases with characteristics including rapid progression, early metastasis and poor prognosis. SCLC is divided into limited-stage small cell lung cancer (LS-SCLC) and ES-SCLC. For patients with LS-SCLC, an objective response rate of approximately 90% and a five-year survival rate of approximately 25% could be achieved through standard chemotherapy and radiotherapy. However, most patients have already been diagnosed with ES-SCLC when seeking medical treatment, with a median survival time of less than one year and a two-year survival rate of less than 10%, and thus ES-SCLC remains a major unmet clinical problem.

The approval of the supplemental new drug application is mainly based on data from the EXTENTORCH study (NCT04012606), a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study, aiming to compare the efficacy and safety of toripalimab or placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. Led by principal investigator Professor Ying CHENG from Jilin Cancer Hospital, the study was conducted across 51 clinical centers nationwide.

In May 2023, the primary endpoints of EXTENTORCH met their pre-defined efficacy boundary, and toripalimab thus became the first PD-1 inhibitor in the world to meet the primary endpoints of both overall survival (OS) and progression-free survival (PFS) in a Phase 3 study for the first-line treatment of ES-SCLC.

At the European Society for Medical Oncology (ESMO) Congress held in October 2023, the EXTENTORCH data was released in the form of an oral presentation for the first time. The study results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy could significantly prolong the PFS and OS of patients and demonstrated a favorable safety profile. This suggests that toripalimab may be an optimal immunotherapy for ES-SCLC. In particular, the median PFS of the toripalimab group reached 5.8 months, and the risk of disease progression or death was reduced by 33.3% (P=0.0002). The one-year PFS was nearly four times higher in the toripalimab group compared with the chemotherapy group (18.1% vs. 4.9%). The median OS of the toripalimab group reached 14.6 months, the risk of death was reduced by 20.2% (P=0.0327), and the one-year OS reached 63.1%.

“SCLC is highly invasive, mestastasizes early, and has a poor prognosis. For a long time, the standard treatment of ES-SCLC has been platinum-based chemotherapy. Although patients are responsive to the initial stage of treatment, they are prone to drug resistance. Immunotherapy, however, has opened a new chapter,” said Professor Ying CHENG from Jilin Cancer Hospital. “The double primary endpoint design of PFS and OS in EXTENTORCH followed a higher statistical standard and achieved positive results for both endpoints. This means that compared to mono-chemotherapy, toripalimab combined with chemotherapy can significantly improve patients’ PFS and OS. The approval of toripalimab’s new indication for the first-line treatment of ES-SCLC will provide a new, effective, safe and affordable treatment option for SCLC patients in China!”

“With the highest number of new cases and deaths, lung cancer has always been the archenemy of tumor treatment,” said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences. “Junshi Biosciences has continuously invested in the research and development of new drugs for lung cancer. To date, three indications have been successfully approved, covering the main subtypes of non-small cell lung cancer and SCLC, as well as patients at all stages from early to advanced. More products and indications are currently in development, and we look forward to bringing better treatment options to lung cancer patients!”