AstraZeneca's Calquence preps for Imbruvica showdown with phase 3 CLL win

AstraZeneca is touting promising clinical data for BTK inhibitor Calquence as it challenges Johnson & Johnson/Abbvie's Imbruvica in chronic leukemia. (AstraZeneca)

Chasing big fish in the BTK inhibitor market, AstraZeneca’s Calquence was looking for a major sales hook. It may have found just that with new late-stage data in a common form of leukemia.

AstraZeneca called an early halt to the phase 3 Ascend trial after interim data showed solo Calquence beat a combination of Rituxan and chemo at fending off disease progression in chronic lymphocytic leukemia (CLL) patients who've failed on prior therapy. The new data could position Calquence for a run at a new FDA indication—and a chance to square off against AbbVie and Johnson & Johnson's powerhouse BTK inhibitor, Imbruvica, in CLL.

It's the first time a BTK inhibitor shone as a monotherapy in relapsed patients when pitted against a standard-of-care cocktail, AstraZeneca's executive vice president of oncology R&D, José Baselga, said in a release.

And the Ascend trial is one of two in CLL the British drugmaker expects to read out this year, alongside Elevate-TN, which is testing Calquence in previously untreated CLL. The med is also in two other phase 3 CLL trials, AZ said.

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Calquence could certainly use the boost from a CLL indication or two. After its initial FDA approval in late 2017, Calquence raked in middling sales in 2018, its first full year on the market. AstraZeneca's hoping its favorable side effects over Imbruvica in mantle cell lymphoma (MCL) and its promise in CLL will help turn the tide.

In the first quarter of this year, Calquence brought in just $29 million worldwide. By contrast, Imbruvica, which is approved for three separate indications in CLL, cleared $784 million in the same time frame.

RELATED: Johnson & Johnson, AbbVie shore up Imbruvica's CLL lead with Gazyva combo win

But AstraZeneca's not fazed by Imbruvica’s significant head start. Calquence has shown some promising early uptake, Dave Fredrickson, EVP and global head of AZ’s oncology business unit, said in December. At the time, the drug was pulling in 50% of new prescriptions for patients with relapsed and refractory MCL.

“We’re starting to get to a place—we’re not quite there yet—where we’re the first choice in front of” Imbruvica for that population,” he told FiercePharma. “Given that we’ve been on the market for now just over a year, we’re pretty excited to see that happening.”

If Calquence does find its sales foothold, it could face new BTK inhibitors looking for their own places in the market. BeiGene is pushing its candidate, zanubrutinib, through the pipeline with phase 2 and phase 3 trials in Waldenstrom’s macroglobulinemia and CLL. And Loxo Oncology, now owned by Eli Lilly, has its LOXO-305 in phase 1/2 testing.

RELATED: AstraZeneca kicks off second blood cancer launch, this time for orphan drug Lumoxiti

With Calquence facing a steep uphill climb, AstraZeneca is further leaning into the hemo-oncology market with the late 2018 launch of orphan drug Lumoxiti for use in hairy cell leukemia patients who have received two prior treatments.

Despite a slim 200- to 400-patient pool in the U.S in that indication, AstraZeneca touted its “deep engagement” with physicians and payers as major factors in the drug’s quick commercial rollout. The company has targeted between 10 and 15 U.S. specialty clinics in its patient push and has projected sales of the drug in the range of $500 million.