Summary
BeiGene, Ltd. (ONC) reported significant progress on two key fronts in late January 2022. The company announced that its supplemental new drug application for BRUKINSA® (zanubrutinib) for Waldenström’s macroglobulinemia (WM) has been accepted by China's NMPA. This acceptance represents a crucial step towards expanding the market access for this important BTK inhibitor in a major global market. Furthermore, BeiGene disclosed positive interim findings from its global Phase 3 RATIONALE 305 trial for tislelizumab. The trial, testing tislelizumab in combination with chemotherapy as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, met its primary endpoint of overall survival (OS) in a specific subgroup of patients with PD-L1 expression. While additional follow-up is required for the broader patient population, these results are highly encouraging, demonstrating the potential of tislelizumab in a significant oncology indication.
Key Highlights
- 1China's NMPA accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).
- 2This sNDA acceptance is a key step for market expansion of BRUKINSA® in China.
- 3Positive interim findings from the global Phase 3 RATIONALE 305 trial of tislelizumab were announced.
- 4The RATIONALE 305 trial tested tislelizumab in combination with chemotherapy for first-line treatment of gastric or G/GEJ adenocarcinoma.
- 5The trial met its primary endpoint of overall survival (OS) in patients with PD-L1 expression at the interim analysis.
- 6Additional follow-up is needed to confirm OS benefits in the intention-to-treat (ITT) population.
- 7The safety profile of tislelizumab in combination with chemotherapy was consistent with previous observations, with no new safety signals.