Good news on Calquence, bad news on tralokinumab says AstraZeneca

AstraZeneca issued a slew of announcements on Wednesday morning, with the first confirming that the US Food and Drug Administration has granted accelerated approval to Calquence (acalabrutinib).

The FTSE 100 drugmaker and its haematology research and development ‘centre of excellence’, Acerta Pharma, said Calquence is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Calquence is approved under the FDA's accelerated approval pathway, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint.

Continued approval for the indication could be contingent upon verification and description of clinical benefit in confirmatory trials, AstraZeneca’s board said.

“The accelerated approval of Calquence is a landmark moment for our company,” said AstraZeneca chief executive Pascal Soriot.

“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.

“Furthermore, today's approval demonstrates our commitment to scientific leadership in oncology and reinforces our progress towards returning to growth.”

Michael L Wang, MD, professor at the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, and principal investigator of the ACE-LY-004 MCL clinical trial, said the acalabrutinib approval represented an “important development” for patients currently battling mantle cell lymphoma, which he described as an “aggressive” type of blood cancer that is typically diagnosed at an advanced stage, and associated with a high relapse rate.

“In addition to the overall response rate, the high complete response rate of 40% seen in this trial illustrates the potential of acalabrutinib to help patients achieve a deep response,” Dr Wang added.

In its second announcement, AstraZeneca - along with its global biologics research and development arm MedImmune - announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 human monoclonal antibody, in severe, uncontrolled asthma.

It said that in STRATOS 2, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AAER), the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker, Fractional exhaled Nitric Oxide (FeNO), compared to placebo.

In TROPOS, tralokinumab did not achieve a statistically-significant reduction in oral corticosteroid (OCS) use, the primary endpoint, when added to the standard of care, in patients dependent on OCS.

“The results are disappointing as we had hoped that tralokinumab would benefit patients with severe asthma, which is a complex disease with limited treatment options today,” said executive vice-president of global medicines development and chief medical officer, Sean Bohen.

Finally, AstraZeneca confirmed that it has completed the commercialisation agreement announced on 14 September with Aspen Global Incorporated, part of the Aspen Group, under which Aspen Global has acquired the residual rights to established anaesthetic medicines comprising of Diprivan, EMLA, Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest.

“AstraZeneca initially entered an agreement with AGI in June 2016, under which AGI gained the exclusive commercialisation rights to the medicines in markets outside the US,” AstraZeneca’s board explained in its statement.

“Under the terms of the new agreement, AGI has now acquired the remaining rights to the intellectual property and manufacturing know-how related to the anaesthetic medicines.”