BeiGene releases positive top-line Phase III results on tislelizumab in NPC

Sino-American biotech firm BeiGene (Nasdaq: BGNE) on Friday announced that the Phase III 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, said BeiGene, whose shares closed up 4.6% at HK$205.80.

“We are excited to see a clinically meaningful improvement in progression-free survival in our Phase III trial for tislelizumab plus chemotherapy in patients with NPC. This is our fifth positive Phase III readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody,” said Dr Yong Ben, chief medical officer, Immuno-Oncology, at BeiGene, adding: “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.”