The updated efficacy analyses showed that tislelizumab in combination with chemotherapy continued to demonstrate a clinically significant progression-free survival benefit for individuals with recurrent or metastatic nasopharyngeal cancer.
BeiGene has announced updated data from the phase 3 RATIONALE-309 trial of tislelizumab, a humanized anti-PD-1 monoclonal antibody, in combination with chemotherapy as a first-line treatment for individuals with recurrent or metastatic nasopharyngeal cancer (RM-NPC).
The updated efficacy analyses showed that the tislelizumab combination continued to demonstrate a clinically significant progression-free survival (PFS) benefit over chemotherapy alone for patients with RM-NPC.
The updated findings were presented at the American Society Clinical Oncology (ASCO) Plenary Series at a session on April 19, 2022.
“These updated findings further support tislelizumab in combination with chemotherapy as a potential standard-of-care first-line therapy for patients with RM-NPC,” Mark Lanasa, chief medical officer of Solid Tumors at BeiGene, said in a statement. “This study’s acceptance for presentation as part of the high-profile virtual ASCO Plenary Series underscores the potential for tislelizumab plus chemotherapy to be a practice-changing option for patients with this disease.”
The safety profile of the tislelizumab combination was generally manageable and consistent with known risks of each treatment agent.
An updated analysis of the primary endpoint, which was PFS, and the secondary endpoints, which were disease progression or death after next-line therapy (PFS2) and overall survival (OS), was performed based on the latest cutoff date, September 30, 2021. The median follow-up was 15.5 months.
Individuals who received a 200 mg dose of tislelizumab and chemotherapy achieved a median PFS of 9.6 months compared to 7.4 months for individuals administered the placebo and chemotherapy.
The trial also allowed individuals from the placebo arm to receive tislelizumab as a monotherapy after disease progression. PFS2 was recorded to determine the optimal treatment sequence.
For individuals treated with tislelizumab and chemotherapy, the median PFS2 was not reached yet. Individuals who were treated with the placebo and chemotherapy had a PFS2 of 13.9.
Investigators also noticed a positive OS trend, but a median OS has not yet been achieved for the tislelizumab arm. The placebo arm had a median OS of 23 months.
The biomarker analyses that were presented included exploratory endpoints including PD-L1 and gene expression profiling (GEP). An improvement in PFS for tislelizumab in combination with chemotherapy was observed, regardless of PD-L1 status.
The gene expression profiling analysis identified a subgroup of individuals who had “hot” immune profiles that were characterized by the highest expression of immune cells. The immune cells included T cells, natural killer cells, dendritic cells, and antigen presentation machinery.
The greatest PFS benefit of tislelizumab as a combination therapy was observed in individuals who had “hot” tumor microenvironment profiles.
In August 2021, the China National Medical Products Administration accepted a new drug application for tislelizumab in combination with chemotherapy as a first-line treatment for individuals with RM-NPC.
BeiGene continues to support regulatory filings by Novartis for first-line treatment in the United States and Europe.
BeiGene presents updated results from phase 3 RATIONALE-309 trial of PD-1 inhibitor tislelizumab in first-line RM-NPC in virtual ASCO Plenary Series. Business Wire. News release. April 19, 2022. Accessed April 20, 2021. https://www.businesswire.com/news/home/20220419005450/en