October 6, 2017
By Alex Keown, BioSpace.com Breaking News Staff
REDWOOD CITY, Calif. – Acerta Pharmaceuticals is being forced to retract claims of a therapeutic benefit of acalabrutinib in a mouse model of pancreatic cancer that was published in three medical journals two years ago due to falsified data.
According to Retraction Watch, an Acerta investigation was conducted into claims put forth in a 2015 abstract published in the New England Journal of Medicine that indicated acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, was showing promise in treating pancreatic cancer in the mouse model. Those claims appeared to be based on falsified data, Retraction Watch said. Citing Ed Tucker, Acerta’s senior VP in charge of Medical Safety, Quality and Compliance, the company “identified an issue” with the data following communication from an external researcher who worked on the preclinical data.
“Through an internal review, we determined that the pre-clinical data cited as support for a statement within the abstract was falsified,” Tucker said, as cited by Retraction Watch.
Tucker pointed to a former employee as the source of the falsified data, although he did not identify the researcher involved with the incident. The U.S. Food and Drug Administration was notified of the false data, but had not requested the company undertake any additional actions regarding acalabrutinib, Tucker told Retraction Watch.
Tucker noted in his interview that acalabrutinib has been tested in multiple clinical trials and the data from those studies “provide a consistent, robust scientific rationale for all acalabrutinib clinical trials.” According to the company, acalabrutinib has been involved in more than 25 clinical trials involving more than 2,000 patients. The drug is being tested against multiple indications in cancer.
That might be good news for Acerta and its majority-owner AstraZeneca. Acalabrutinib is being presented to the FDA for review for patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy. In August, the FDA granted priority review for Acerta’s New Drug Application. Acalabrutinib has also been awarded the FDA’s Breakthrough Therapy Designation for the treatment of MCL.
It was the promising clinical data for Acerta’s acalabrutinib that got AstraZeneca ’s attention in 2015. In Phase I and Phase II studies, acalabrutinib showed a 95 percent response rate in patients with relapsed CLL. The promising data prompted AstraZeneca to act. In December 2015, U.K.-based AstraZeneca acquired a 55 percent stake in Acerta for $3 billion. The deal brought acalabrutinib under the AstraZeneca umbrella. If acalabrutinib is approved in both the United States and the European Union, AstraZeneca will have the option to acquire the remaining 45 percent of Acerta for approximately $3 billion.
In 2016, acalabrutinib was granted orphan status for the treatment of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL) and lymphoplasmacytic lymphoma (Waldenström’s macroglobulinaemia, MG).
If acalabrutinib is approved by the FDA, it could become a key revenue driver for AstraZeneca. Some analysts have predicted the drug could generate up to $5 billion annually if it’s approved for multiple indications.
