Blood cancer drug Calquence so far is one of the smaller sales contributors to AstraZeneca's cancer portfolio, but that could soon change if data in leukemia helps it square up to its main rival, AbbVie and Johnson & Johnson's Imbruvica.
AstraZeneca already announced the ELEVATE-TN trial found Calquence, combined with Gazyva, extended the amount of time previously untreated chronic lymphocytic leukemia patients lived without having a disease relapse when compared to Gazyva and chemotherapy. A lingering question was by how much, and how that compared to a similar trial run with Imbruvica.
A second data point of interest to oncologists will be a separate trial arm testing Calquence alone against the Gazyva/chemo combo, in which AstraZeneca said Calquence also showed a positive benefit. A less-toxic regimen may be welcomed by many elderly CLL patients, who can be on treatment for years, as well as the community-based oncologists who must manage their care, Susan Galbraith, AstraZeneca's head of oncology research and early development, said on the company's third-quarter earnings call today.
Detailed data are due by the end of the year, with the American Society of Hematology meeting in December a likely forum for a full readout.
To Calquence has secured approval for a condition called mantle cell leukemia, which affects a relatively small patient population compared with CLL. AstraZeneca launched the drug in late 2017, and it earned $108 million in sales over the first nine months of this year.
But Imbruvica — which, like Calquence, binds with an immunological target enzyme called Bruton's tyrosine kinase — shows how AstraZeneca's sales could grow based on positive data. Imbruvica was worth $6.2 billion in revenue to its co-owners in 2018, rivaling AstraZeneca's entire oncology portfolio.
Galbraith said Calquence "hits the target harder" and therefore should have greater efficacy and fewer side effects than Imbruvica, although further data will prove whether that claim can be backed up. Among the Calquence studies underway is a head-to-head trial against Imbruvica in CLL.
The ELEVATE-TN data should give some idea of how that head-to-head will turn out. A similar trial called iLLUMINATE showed that Imbruvica and Gazyva reduced the risk of disease progression by 77% when compared to Gazyva plus placebo. That trial did not have results from an Imbruvica monotherapy arm, as ELEVATE-TN will.
Another indicator is the ASCEND trial, which compared Calquence against a Rituxan-based combination, in which Calquence reduced the risk of disease progression by 69%.
Imbruvica hasn't been compared as a monotherapy against a Rituxan combination. But in combination with Rituxan and chemotherapy in the HELIOS trial, Imbruvica reduced the risk of disease progression 80% when compared to the Rituxan combo alone.
AstraZeneca has submitted the ELEVATE-TN and ASCEND data to the Food and Drug Administration, which has given Calquence Breakthrough Therapy designation. The company expects an FDA decision in the first half of 2020.
A jump in Calquence sales could support AstraZeneca's push to transform into an cancer-focused big pharma group. Led by lung cancer drug Tagrisso, oncology sales nearly doubled to just over $6 billion from 2017 to 2018, and this year are on track to exceed $8 billion.
Calquence came to Astra through the 2015 acquisition of Acerta Pharma. That transaction was rated this week by SVB Leerink analyst Geoffrey C. Porges as one of the five best acquisitions of the last decade based on the company valuation created.
Astra announced as part of its third-quarter earnings call that it had settled patent-infringement litigation with AbbVie and J&J.