On September 20, 2022 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported 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.
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"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. "We are particularly grateful to our patients, researchers, and R&D teams that participated in the clinical trials, whose efforts and contributions allowed our study to progress during the COVID-19 pandemic. We will continue to advocate for the use of toripalimab in the treatment of lung cancer as well as other cancers, and we hope to provide many more patients with better treatment options and greater survival benefits as soon as possible!"
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. We are excited for toripalimab’s continuous contribution to the battle against lung cancer!"
Between April 2, 2019 to August 5, 2020, the CHOICE-01 study enrolled a total of 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) (Free ASCO Whitepaper) ("ASCO") Plenary Series March Program and the ASCO (Free ASCO Whitepaper) 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 can significantly improve the PFS and the OS of patients with a manageable safety profile regardless of PD-L1 expression status.
As of October 31, 2021, in 245 non-squamous NSCLC patients, the median PFS of toripalimab in combination with chemotherapy was 9.7 months, which was 4.2 months longer than placebo in combination with chemotherapy (HR = 0.48 [95% CI: 0.35-0.66], p < 0.0001); the median OS of toripalimab in combination with the chemotherapy group has yet to be reached, while OS benefits had already been observed, reducing the risk of death by 52% (HR=0.48 [95%CI: 0.32-0.71]).
About NSCLC
Lung cancer is currently the second most prevalent malignant tumor with the highest mortality rate in the world[1], and the most prevalent with the highest mortality rate in China[2]. According to data released by the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000 and accounted for 17.9% of all new cancer cases in China[2]. In the same year, the number of lung cancer deaths in China amounted to 715,000 and accounted for 23.8% of all cancer deaths in China[2]. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases[3]. Non-squamous NSCLC patients account for approximately 70% of all NSCLC patients[4]. Existing domestic and overseas studies have shown that the use of anti-PD-(L)1 monoclonal antibodies as monotherapy or in combination with chemotherapy has already become new standard for the first-line treatment of advanced driver gene-negative NSCLC.
(Press release, Shanghai Junshi Bioscience, SEP 20, 2022, View Source [SID1234663442])