The study data showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy in the first-line treatment of patients with advanced NSCLC without EGFR/ALK mutations could significantly improve the PFS and the OS of patients with a manageable safety profile regardless of PD-L1 expression status.
Shanghai Junshi Biosciences (01877: HK, 688180: SH), a well-known innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for Toripalimab in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.
"We are very pleased that Toripalimab’s first indication for the treatment of lung cancer has been approved, which means we will be able to help more patients fight against malignant tumors with the highest incidence and mortality rates in China,” said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences.
Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimab’s performance in clinical trials. “In China, the number of lung cancer patients is massive and so is the demand for treatment. The CHOICE-01 study provided us with reliable and substantiating data, confirming that the addition of toripalimab to standard first-line chemotherapy can bring longer progression-free survival (PFS) and overall survival (OS) to patients with advanced NSCLC, regardless of PD-L1 expression and with a manageable safety profile. For patients with advanced non-squamous NSCLC, published data reveal that the 2-year OS rate is around 50%, and according to the CHOICE-01 study results, toripalimab in combination with chemotherapy is the only PD-(L)1 inhibitor combination in this field that can achieve a 2-year OS rate of more than 60%, not to mention a 50% decrease in risk of death, indicating that toripalimab plus standard chemotherapy can significantly increase survival benefits for patients.”
Between April 2, 2019, and August 5, 2020, the CHOICE-01 study enrolled 465 NSCLC patients in 63 centers in China, among which 245 non-squamous NSCLC patients were randomly allocated in the ratio of 2:1 to receive Toripalimab/placebo in combination with pemetrexed and cisplatin/carboplatin. After disease progression, eligible control subjects could receive crossover treatment with Toripalimab monotherapy. Previously, the latest research results of the CHOICE-01 study were announced at the 2022 American Society of Clinical Oncology (ASCO) Plenary Series March Program and the ASCO annual meeting. The study data showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy in the first-line treatment of patients with advanced NSCLC without EGFR/ALK mutations could significantly improve the PFS and the OS of patients with a manageable safety profile regardless of PD-L1 expression status.