- The Food and Drug Administration on Tuesday conditionally approved AstraZeneca plc's blood cancer drug Calquence as a treatment for a type of lymphoma, giving the British drugmaker a potential competitor to AbbVie Inc.'s fast-growing Imbruvica franchise.
- Results from an open-label study of Calquence, first released Oct. 31, show treatment with the BTK inhibitor led to complete responses in 40% of patients with previously treated mantle cell lymphoma, an aggressive B-cell cancer of the body's lymph system.
- AstraZeneca gained access to Calquence when it bought a majority stake in private drugmaker Acerta Pharma for $4 billion in late 2015.
AstraZeneca sees big things ahead for Calquence (acalabrutinib), looking beyond mantle cell lymphoma (MCL) and into other B-cell malignancies.
"The accelerated approval of Calquence is a landmark moment for our company," AstraZeneca CEO Pascal Soriot said in a Oct. 31 statement. "It provides an exciting new treatment option for patients with mantle cell lymphoma and marks the first approval of a medicine that will be the cornerstone of our presence in haematology."
Mantle cell lymphoma, a type of non-Hodgkin lymphoma (NHL), accounts for roughly 3% to 10% of all NHL cases in the U.S., according to the FDA. Initial treatments may beat back the disease, but AstraZeneca notes there is a high rate of relapse.
Approval of Calquence came several months ahead of schedule. The FDA accepted AstraZeneca's application for approval in August under priority review, setting up a target action date in the first quarter of next year.
Results from an open-label, single arm study of the drug in 124 adult patients showed an 80% overall response rate (ORR), split evenly between partial and complete responses.
Those response rates put Calquence slightly ahead of the mark set by Imbruvica (ibrutinib) in MCL, where it led to a 66% ORR and 17.1% complete response (CR) rate.
"It is possible that acalabrutinib's higher CRs could lead to greater durability of response, although this is dependent on the relative length of follow-up in each data set," wrote Cowen & Co. analyst Steve Scala in a Oct. 31 note discussing Calquence's competitiveness to Imbruvica.
Imbruvica, however, has quickly become a blockbuster franchise, notching global sales of $1.87 billion through the first nine months of the year on the back of several indications in various blood cancers.
Pulling sales away from Imbruvica will be a challenge and, as EvercoreISI's Josh Schimmer notes, MCL sales only account for 10% of AbbVie's revenue from the drug.
"We don't anticipate a meaningful shift away from Imbruvica use given its strong history in the indication (approved since Nov 2013)," Schummer explained in a Oct. 31 note.
AstraZeneca priced Calquence at an average monthly cost of $14,259 for a 100 mg dose give twice daily — slightly lower than Imbruvica's current wholesale acquisition cost.
A Phase 2 study known as ACE-LY 308 is currently underway to test Calquence's benefit in first-line treatment of MCL when combined with bendamustine and rituximab.