Astex welcomes positive results for Kisqali breast cancer treatment
Astex is celebrating a double dose of positive results in what is its 20th anniversary year.
The Cambridge Science Park-based biotech company has welcomed data showing Kisqali, the breast cancer drug it developed with Novartis, is helping to extend lives
The drug was recommended by NICE (National Institute for Health and Care Excellence) in November 2017 as a cost-effective treatment option for post-menopausal women within England and Wales with advanced breast cancer.
It earned marketing approval in the US and EU in 2018 in combination with an endocrine-based therapy for pre- and perimenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.
Now new data from theMONALEESA-7 trial has showed that after a median of 42 months follow-up, survival rate for women was 70.2 per cent for women who received Kisqali combination therapy compared to 46.0 per cent for women who received endocrine therapy alone.
Dr Harren Jhoti, president and CEO of Astex UK, said: “It’s fantastic to see such a significant advance in cancer treatment.
“Ultimately as life science entrepreneurs, our goal is to improve lives through the discovery of new therapies.
“Kisqali was the first new cancer drug discovered and developed from our collaboration with Novartis to reach marketing approval and was a milestone for the company in 2017. These new data are a real milestone for patients.”
The data was announced at 2019 American Society of Clinical Oncology (ASCO) annual meeting and heralded as a significant breakthrough for patients.
Kisqali was discovered and developed by the Novartis Institutes for Biomedical Research (NIBR) under a research collaboration entered into with Astex in 2005.
It is a CDK4/6 inhibitor that slows the progression of cancer by inhibiting the proteins CDK4 and CDK6 which, when over-activated, can enable cancer cells to grow and divide quickly.
Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co in Tokyo, Japan, in October 2013.
Astex and Otsuka have also been buoyed by the results of the phase III ASCERTAIN study of the novel oral cedazuridine and decitabine fixed-dose combination in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML).
The aim was to show oral delivery of the approved DNA hypomethylating agent, decitabine at exposures equivalent to the already-approved intravenous form of decitabine administered over five days.
Astex intends to file a new drug application with the US Food and Drug Administration by the end of the year. It is also developing cedazuridine and decitabine fixed-dose combination for other patients, including those with acute myeloid leukemia and low-risk MDS
Mohammad Azab, Astex Pharmaceuticals’ president and chief medical officer, said: “We are delighted with the outcome of the ASCERTAIN trial, and the demonstration that the fixed dose combination of cedazuridine with decitabine enables successful oral delivery of decitabine, alleviating the significant burden of five days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years.
“Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who contributed to this effort.”