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On October 26th, Roche submitted its second application for the listing of Tecentriq in China, which is expected to be officially approved in the near future for patients with non-excisive hepatocellular carcinoma (HCC) who have not received systemic treatment throughout the body.
HCC is a cancer with limited treatment options and is one of the leading causes of cancer death worldwide, accounting for about 90% of liver cancer.
750,000 new cases of hepatocellular carcinoma worldwide each year, most of them from Asia and almost half from China.
according to the 2015 China Cancer Annual Report, there are about 370,000 new cases of hepatocellular carcinoma in China each year, resulting in 326,000 deaths.
, roche Tecentriq and Beval pearl monoantimmune, if approved, would be the first joint immunology program for first-line treatment of HCC.
Roche submitted a listing application to the NMPA based on IMbrave 150 Research China Queue Data, which assessed the efficacy and safety of Tecentriq-Beval pearl mono-vs Solafini first-line treatment of HCC patients, using a global multicenter, open label design, and 501 non-removable HCC patients who had not previously received systematic treatment were grouped by 2:1.
133 of the 194 Chinese patients included in the study (137 from the IMbrave150 Global Study and 57 from the China Extended Study) were randomly treated with Tecentriq and Beva bead monoantigen, and 61 were treated with soraphinib.
results showed that Tecentriq-Avastin significantly extended the total survival of Chinese patients (immature vs. 11.4 months) as a first-line therapy, reducing the risk of death by 56% (HR s 0.44), while significantly extending patient PFS (5.7 vs 3.2 months) and reducing the risk of disease deterioration by 40% (HR s 0.60).
this data is consistent with the global data from the IMbrave 150 study.
safety, Tecentriq-Beval bead monoantin is generally well-resistant, toxic and consistent with known data.
first approved in China in February 2020 for the treatment of small cell lung cancer (SCLC).
first-line liver cancer adaptation, if approved, will become Tecentriq's second approved in China.
addition, Roche's 3rd Registration Listing Application for Tecentriq in China has been included in the priority review for testing positive for ≥50% tumor cell PD-L1 (TC≥50%) or tumor-immersed PD-L1 positive immune cells (5) IC) first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) with a genetic mutation-negative and mesolytic lymphoma kinase (ALK) covering ≥10% of the tumor area (IC≥10%).