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AstraZeneca Phase 3 ELEVATE-TN Trial Of Calquence In CLL Meets Primary Endpoint

British drug major AstraZeneca Plc (AZN.L,AZN) announced Thursday that the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukaemia or CLL.

In the positive trial, Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival or PFS when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.

The study also met a key secondary endpoint showing Calquence monotherapy achieved improvement in PFS.

The company noted that Calquence alone or in combination significantly increased the time patients lived without disease progression.

This is the second Calquence pivotal trial in CLL, the most common type of leukaemia in adults, to meet its primary endpoint early. Earlier, the company reported positive results of the ASCEND trial in May.

José Baselga, Executive Vice President, Oncology R&D said, "The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year."

At present, Calquence is approved to treat adults with relapsed or refractory mantle cell lymphoma or MCL in the US, Brazil, the UAE, and Qatar. It is being developed for the treatment of CLL and other blood cancers.

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