Breaking Down the Implications of Calquence Combination Therapy in MCL

The treatment combination of Calquence (acalabrutinib) plus bendamustine and Rituxan (rituximab) was recently granted full approval by the Food and Drug Administration (FDA) in previously untreated mantle cell lymphoma (MCL) on Jan. 17, making this the first and only Bruton tyrosine kinase (BTK) inhibitor approved in the front line setting of this disease, according to a news release from AstraZeneca. This regulatory approval stands to impact treatment and provides an additional therapeutic option for this patient population, according to Dr. Tycel Phillips.

The regulatory approval of the Calquence combination is supported by data from the ECHO trial, according to the FDA website, which compared Calquence plus bendamustine and Rituxan with placebo plus bendamustine and Rituxan. Notably, the progression-free survival (PFS) seen with the combination was statistically significantly longer versus those treated with placebo.

In an exclusive interview with CURE®, Phillips discussed the implications of this FDA approval for both patients and physicians alike, as well as highlighted how the ECHO trial compares with previous trials of its kind in patients with MCL. Phillips is an Associate Professor in the Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation, at City of Hope in Duarte, California.

Transcript:

[This FDA approval] provides another [treatment] option for this patient population. There is quite a bit of familiarity with bendamustine and Rituxan, and obviously, with BTK inhibitors in the relapsed/refractory space. Given this, and the experience patients and physicians have with both of these drugs, it allows for this combination to be implemented a little bit easier than, say, if these were two very novel medications and there was unfamiliarity with the physician and the patient themselves. However, given the knowledge of these two drugs in the physician aspect, and in the community space, it allows a bit easier of an uptake in this setting.

The key takeaway, since this indication was approved, is that it did meet the primary end point, [meaning] there was a PFS benefit with Calquence plus bendamustine and Rituxan over bendamustine and Rituxan. There was no overall survival [OS] benefit, although there was a trend toward OS, but it did not meet statistical significance in this patient population

A key point, unlike what we saw with the SHINE [trial] is that there was no unexpected deaths, unexplained toxicities or increase in toxicities in the experimental arm, so safety was not a concern. [Notably], this is what likely doomed the SHINE study.

Transcript has been edited for clarity and conciseness.

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