Watch out AbbVie and J&J, AstraZeneca just took another big swing at one of your star cancer drug franchises
AstraZeneca reported Tuesday that its BTK contender Calquence (acalabrutinib) aced a Phase III trial as a second-line therapy for chronic lymphocytic leukemia patients, allowing researchers to call it early as they position this drug for greener pastures.
We won’t get the data until later in the year, but the UK pharma giant $AZN says they nailed statistically significant results on progression-free survival compared to a control group getting a combo of rituximab plus physician’s choice of idelalisib or bendamustine. And José Baselga, the company’s oncology research chief, says this is the first time a monotherapy has proven superior to a standard of care in this segment of the population.
Later this year we’ll get the Phase III data for frontline CLL as AstraZeneca patiently builds its case for a rival franchise operation. The company won its first OK for Calquence in late 2017 for mantle cell lymphoma, which marked their first entry for this drug. And if AstraZeneca CEO Pascal Soriot gets his way, they’ll soon be going head-to-head on CLL with J&J $JNJ and AbbVie’s $ABBV Imbruvica, the pioneering BTK on the market.
Imbruvica earned $3.6 billion for J&J and Abbie last year, up 40% over the year before.
The Phase III win is the latest score for AstraZeneca since it bought this drug in the $7 billion Acerta Pharma acquisition back in 2015.
Expanding the market for Calquence has been part of Soriot’s oncology game plan for some time. Just as he built Lynparza and Tagrisso into major new revenue streams for the company, the R&D group has been steadily plugging away at new cancer indications for its other big players.
As is typically true for all cancer drug franchises, AstraZeneca and the AbbVie/J&J operation aren’t working in a vacuum. BeiGene $BGNE, the China-based biotech which is angling to prove that it can make better cancer drugs than the ones already on the market, has its own BTK drug — zanubrutinib — which it is lining up in early-stage studies for CLL and more. Much more. Here’s BeiGene’s breakdown of the studies:
Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with Gazyva (obinutuzumab); global Phase 2 trial in patients with R/R marginal zone lymphoma (MZL), a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.