The Chinese Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted for review Beigene’s application seeking approval for tislelizumab, in combination with standard chemotherapy, as a first-line treatment for people with advanced non-squamous non-small cell lung cancer (NSCLC).
This is Beigene’s second supplemental new drug application (sNDA) in China for its experimental candidate tislelizumab. The first, accepted for review in April, asked that this first-line combination therapy be approved for people with advanced squamous NSCLC.
“We are pleased to submit our second sNDA in first-line advanced NSCLC and the fourth potential indication for tislelizumab in China,” Xiaobin Wu, PhD, BeiGene’s president and general manager in China, said in a press release.
“Together with the previously accepted filing in patients with squamous histology, we look forward to continuing our dialogue with the CDE and to hope to bring this innovative treatment to hundreds of thousands of Chinese patients and families impacted by this devastating disease every year,” Wu said.
Tislelizumab, an immune checkpoint inhibitor, is an antibody designed to boost anti-cancer immune responses by preventing a mechanism often used by cancer cells to evade immune attacks. It targets the PD-1 receptor at the surface of immune T-cells, blocking its binding to the PD-L1 protein on cancer cells.
Notably, and distinct from other PD-1-targeted antibodies, tislelizumab has an engineered region that minimizes its interaction with other immune cells. This is thought to reduce potential side effects.
In China, the therapy is approved for people with classical Hodgkin’s lymphoma who received at least two prior therapies. It also is approved for patients with advanced urothelial carcinoma — the most common type of bladder cancer — with high levels of PD-L1 and whose disease has progressed during or shortly after platinum-based chemotherapy. Tislelizumab is not approved for any indication outside of China.
The newly-accepted sNDA was supported by positive interim data from an ongoing Phase 3 trial (NCT03663205) known as BGB-A317-304. That study is evaluating the safety and effectiveness of tislelizumab, in combination with standard chemotherapy, versus chemotherapy alone in 334 people with previously untreated advanced non-squamous NSCLC.
The participants had tumors with no mutations in the EGFR or ALK genes. Each was randomly assigned to receive either a combination of tislelizumab, at 200 mg every three weeks, with chemotherapy, or chemotherapy alone, for up to three years. Alimta (pemetrexed) and platinum chemo cisplatin or carboplatin were given as the chemo treatment, at the investigators’ discretion.
The trial’s main goal is to assess whether the tislelizumab combination therapy is superior to chemotherapy alone at extending the time patients live without signs of disease progression.
Secondary goals include the proportion of patients responding to treatment, duration of responses, overall survival, health-related quality of life, and safety measures.
A preplanned interim analysis showed that the trial met its primary goal, with participants given the tislelizumab combination living significantly longer without disease worsening than those on chemotherapy alone.
The safety profile of the combination treatment was consistent with that known for each individual therapy, with no new safety concerns reported.
“The positive outcome at interim analysis for tislelizumab in this study and in other clinical trials, including for first-line squamous NSCLC, demonstrate that it is a promising option for people living with this advanced cancer,” Shun Lu, MD, the trial’s lead investigator and a professor at Shanghai Chest Hospital, Jiao Tong University, said in a Beigene press release announcing the interim data.
Beigene plans to present the trial’s full results at an upcoming meeting.
“We have three additional Phase 3 trials for tislelizumab in lung cancer and we are looking forward to continuing to expand the label for tislelizumab in lung cancer and other indications,” Wu said.
Two of these trials are still recruiting patients at several clinical sites in China. One study is seeking participants with NSCLC (NCT04379635) who have not received prior therapy; more information can be found here. The other trial is assessing the therapy in people with extensive-stage small cell lung cancer (NCT04005716) who had not received previous treatment. More information on its contacts and locations can be found here.
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