Policy & Regulation
China Regulator Accepts Supplemental Biologics License Application for Tislelizumab in Second- or Third-line Non-Small Cell Lung Cancer
5 March 2021 - - A supplemental Biologics License Application for anti-PD1 antibody tislelizumab was accepted by the Center for Drug Evaluation of the China National Medical Products Administration for treatment in the second- or third-line setting of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy, China-based biotechnology company BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) said.

RATIONALE 303 Trial of Tislelizumab Compared to Docetaxel in Patients with Locally Advanced or Metastatic NSCLC Who Progressed on Prior Platinum-Based Chemotherapy

The sBLA is supported by clinical results from the Phase 3 RATIONALE 303 trial, a randomized, open-label, multicenter global Phase 3 clinical trial (NCT03358875) designed to evaluate the efficacy and safety of tislelizumab compared to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on a prior platinum-based chemotherapy.

The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression; key secondary endpoints include objective response rate, duration of response, progression-free survival, and safety.

A total of 805 patients in 10 countries across Asia, Europe, the Americas, and Oceania were randomized 2: 1 to either the tislelizumab arm or the docetaxel arm.

As announced in November 2020, RATIONALE 303 met the primary endpoint of OS at the planned interim analysis, as recommended by the independent Data Monitoring Committee.

The safety profile of tislelizumab was consistent with the known risks with no new safety signals identified.

BeiGene expects to present results from the RATIONALE 303 trial at an upcoming medical conference in the first half of 2021.

In China, the lung cancer incidence rate is increasing.i There were approximately 815,563 new cases of lung cancer in China in 2020, and it is the leading cause of cancer-related death in both men and women, with approximately 714,699 deaths in China in 2020.ii Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 80 to 85 % of all cases.

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene's immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.

Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin's lymphoma who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Switzerland-based Novartis (NYSE: NVS) entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.
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