Beigene gets a Brukinsa boost, but is Calquence the one to beat?

Beigene has long argued that Brukinsa is the best BTK inhibitor, and the final analysis of the phase 3 Alpine trial might help support this claim. The study, in relapsed or refractory chronic lymphocytic leukaemia, found Brukinsa to yield longer progression-free survival than Johnson & Johnson/Abbvie’s Imbruvica, though the exact numbers remain under wraps for now. The trial had already shown superiority on overall response rate, the primary endpoint. CLL is a huge setting for the BTK inhibitors, though poor tolerability is Imbruvica’s Achilles’ heel. Beigene describes Brukinsa as having maximised receptor occupancy and minimal off-target binding, lessening toxicities, a claim backed up by data presented at EHA last year. Still, this is the same argument that Astrazeneca is making for its BTK inhibitor Calquence, which is already approved and taking share from Imbruvica on this basis. Calquence’s CLL trial Elevate-RR only showed non-inferiority to Imbruvica, however, albeit with better toxicity. This makes Calquence the one that Brukinsa has to beat, though Beigene investors were sufficiently cheered to send the company’s stock up 21% yesterday. At the very least, a green light at Brukinsa’s January 2023 Pdufa in CLL now looks assured.