AstraZeneca stocks up on Calquence ammunition for big BTK rivalry with J&J, AbbVie
Catching up with J&J and AbbVie on the BTK inhibitor front, AstraZeneca says Calquence has hit a home run in a Phase III trial for first-line chronic lymphocytic leukemia.
At an interim analysis, researchers say the drug, when combined with Roche’s Gazyva (obinutuzumab), has already demonstrated a progression-free survival benefit over the chemo-based regimen featuring chlorambucil and obinutuzumab. The primary endpoint win was both statistically significant and clinically meaningful, the company says, without disclosing any numbers.
A third group, which received Calquence monotherapy, also did better in PFS than the standard-of-care — a secondary endpoint. There was, however, no word on other outcome measures such as objective response rate, time to next treatment and overall survival.
José Baselga, who has laid out his ambition for the oncology R&D group that he now leads in a series of recent interviews, said the results will cement regulatory submissions later this year.
The dossier will also include results from a previous Phase III on patients with relapsed or refractory chronic lymphocytic leukemia.
Imbruvica — the blockbuster developed by J&J and AbbVie — in combination with Gazyva became the first non-chemotherapy, anti-CD20 regimen to be sanctioned for treatment-naïve CLL this January, marking the 10th approval since its 2013 launch. The FDA has also OK’d its use in this setting on its own.
In 2018 Imbruvica racked up $2.6 billion in sales, dwarfing Calquence — approved for mantle cell lymphoma late 2017 — which generated $62 million. And China’s BeiGene is coming up from behind with its own ‘breakthrough’ candidate.