AstraZeneca has two wins under its belt with the release of promising late-stage studies for drugs that treat ovarian cancer and leukemia.
AstraZeneca and co-developer Merck announced positive results from the European-based Phase III PAOLA-1 trial in women with advanced ovarian cancer.
Industry newsletter Endpoints reported the wins show AstraZeneca has a lead over other pharma companies in PARP drugs used in cancer treatment. PARP is type of enzyme tied to many functions of the cell, including repair of DNA damage.
One trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival for Lynparza, a release stated. Specifics will be released at an upcoming medical conference.
José Baselga, AZ’s executive vice president, oncology R&D, said: “The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer. Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible.”
AstraZeneca also announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Calquence as a treatment for adult patients with chronic lymphocytic leukemia, one of the most common types of leukemia in adults.
The FDA granted the BTD based on positive results from the interim analyses of late phase clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.
This is the 10thbreakthrough designation that AstraZeneca has received from the FDA since 2014. An FDA BTD is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement over currently-available medicines.
Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma in the US, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina and recently Singapore and is being developed for the treatment of CLL and other blood cancers.
.As part of a clinical development program, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 26 company-sponsored clinical trials.
Chronic lymphocytic leukemia (CLL) is one of the most common type of leukemia in adults, with an estimated 105,000 new cases globally and 20,720 new cases in the US.
In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.
AstraZeneca stock has been trading near a 52-week high after a string of positive reports.
The British-based company has headquarters, administrative and logistics operations in Delaware that employ about 1,500.
Cost of the drugs for those without insurance runs more than $3,000 a month for Lynparza and $7,000 for Calquence. AstraZeneca offers patient assistance plans.
