CAMBRIDGE, Mass. & BEIJING– BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the Phase 3 RATIONALE 309 trial of its anti-PD-1 antibody tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC) met its primary endpoint of progression-free survival (PFS) at the interim analysis, as recommended by an independent data monitoring committee. In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat (ITT) population when compared to chemotherapy alone, as assessed by an independent review committee (IRC). The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.
“We are excited to see a clinically meaningful improvement in progression-free survival in our Phase 3 trial for tislelizumab plus chemotherapy in patients with NPC. This is our fifth positive Phase 3 readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. “We are grateful for the patients and clinicians who participated in this trial and hopeful that they may have a new treatment option in the future.”
BeiGene plans to discuss these data with health authorities and present data at an upcoming medical conference.
