China NMPA Approves Tislelizumab in Non-Small Cell Lung Cancer and Hepatocellular Carcinoma - Seite 2

The approval of tislelizumab for the first-line treatment of patients with advanced non-squamous NSCLC was supported by clinical results from a Phase 3 trial (NCT03663205) of tislelizumab in combination with pemetrexed and platinum chemotherapy (either carboplatin or cisplatin) in patients with stage IIIB or stage IV non-squamous NSCLC, compared to pemetrexed and platinum alone. A total of 334 patients in China were enrolled in the trial, randomized 2:1 to either the tislelizumab and chemotherapy arm or the chemotherapy arm. As announced in April 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC), in the pre-planned interim analysis. The safety profile of tislelizumab in combination with chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified. The results of the interim analysis of the trial were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September 2020.

NMPA Approval in Second- or Third-Line HCC

The NMPA conditional approval of tislelizumab in patients with HCC who have received at least one systemic therapy is based on clinical results from a single-arm, open-label, multicenter, global pivotal Phase 2 trial (NCT03419897) conducted in 249 patients from eight countries and regions in Asia and Europe, including 138 patients (55.4%) who received one line of prior systemic therapy and 111 patients (44.6%) who received at least two lines of prior therapies. Of all the patients enrolled in the trial, the median age was 62 years and 63.9% of patients had history of viral hepatitis, with hepatitis B accounting for the majority (51.4%) followed by hepatitis C (14.5%).

“Hepatocellular carcinoma is a difficult-to-treat primary liver cancer, most commonly found in those living with chronic liver diseases, such as hepatitis B and C. Based on the encouraging efficacy and safety results in patients with advanced liver cancer from this trial, tislelizumab has the potential to bring long-term survival benefits to patients with second- or third-line HCC in China,” commented Zhenggang Ren, M.D., Ph.D., Professor at Zhongshan Hospital, Fudan University, and the trial’s leading investigator in China.