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BeOne Medicines Ltd. 8-K Report, Corporate Update (Jan 25, 2022)

Filed January 25, 2022For Securities:ONCBEIGF

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.

Frequently Asked Questions

The acceptance of the supplemental new drug application by the China National Medical Products Administration (NMPA) is a critical regulatory milestone. It moves BeiGene closer to potentially gaining approval and expanding the commercial availability of BRUKINSA® for Waldenström’s macroglobulinemia patients in China, a significant market.

The trial showed positive interim results, meeting its primary endpoint of overall survival (OS) in patients with PD-L1 expression when tislelizumab was combined with chemotherapy for first-line treatment of gastric or G/GEJ adenocarcinoma. While more data is needed for the full patient population, this suggests a potential benefit in a major cancer indication.

No, the company reported that the safety profile of tislelizumab when used in combination with chemotherapy was consistent with previously observed data, and no new safety signals were identified. This indicates a manageable safety profile in this combination therapy.

The company stated that additional follow-up is required to confirm the overall survival (OS) benefits in the entire intention-to-treat (ITT) population. This suggests ongoing data collection and analysis are expected.