Beigene’s eighth-to-market strategy crystallises

There has been no shortage of latecomers to the PD-(L)1 party, and yesterday investors got a glimpse of how one of these might shape up against the market leaders. Beigene, a China-based but US-listed biotech, revealed the results of its contender tislelizumab from a Chinese phase II study it says could lead to approval. The indication – classical Hodgkin’s lymphoma – is intriguing because it is one of the few haematological malignancies thought to be amenable to checkpoint blockade, thanks to the prevalence in patients of the 9p24.1 genetic alteration. And as Opdivo and Keytruda are already approved here a cross-trial comparison with Beigene’s data can be made – though the settings are subtly different. Beigene seems undeterred by the prospect of being behind Opdivo, Keytruda, Tecentriq, Imfinzi and Bavencio, and potentially Sanofi/Regeneron’s cemiplimab and Novartis’s PDR001 too, and its strategy will see tislelizumab positioned initially in China, where Opdivo recently became the first anti-PD-1 to be approved, albeit for lung cancer. How the plan shapes up in the US, where investors are notoriously sceptical about study data generated in China, is a separate question.

Selected trials in classical Hodgkin's lymphoma
Product Company Study Setting ORR CR
Opdivo Bristol-Myers Squibb/Ono Checkmate-205 & 039 Post autologous SCT + Adcetris 66% 6%
    Checkmate-205 & 039 Post autologous SCT 69% 14%
Keytruda Merck & Co Keynote-087 Fourth line 69% 22%
Tislelizumab  Beigene/Celgene Phase II trial in 70 Chinese pts Failed or ineligible for autologous SCT 73% 50%
Source: US product labels & company filings.

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