AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the 1st-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations. The trial met its primary endpoint in the intent-to-treat* population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone. The results, including biomarker sub-group analyses, will be presented at a forthcoming medical meeting. The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults.1 José Baselga, Executive Vice President, Oncology R&D, said: "This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile." The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III 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 10th BTD that AstraZeneca has received from the FDA since 2014.
LONDON – An experimental AstraZeneca drug that failed last year as a treatment for a rare cancer of the eye has been awarded special "orphan" status in the United States for a type of thyroid cancer. The British drugmaker, which is relying on cancer treatments to revive its fortunes following a wave of patent expiries, said on Thursday the decision showed the potential importance of selumetinib for some patients. Orphan status is awarded to medicines promising significant benefit in treating rare, life-threatening diseases and the designation provides companies with special development and market exclusivity incentives. AstraZeneca's drug is being tested for patients with advanced differentiated thyroid cancer who fail to respond adequately to radioactive iodine. Selumetinib, which belongs to a class of cancer drugs known as MEK inhibitors, failed to meet its goal in a late-stage trial for uveal melanoma in July 2015.
This episode of the pharmaphorum podcast focuses on lung cancer, with AstraZeneca's VP, Global Franchise Head, Tagrisso TDR (Tumour Drivers and Resistance) Patrick Connor explaining why the disease should be a priority for society. He also discussed the changes he hopes to see in lung cancer and where AstraZeneca's oncology business is headed, the pharma company's work on biomarkers and where companion diagnostics fit into its work. Episode 14 of the pharmaphorum podcast is a companion piece to our previous instalment, which heard from AstraZeneca's Paul Naish about the quality of online information available for lung cancer patients. You can listen to episode 14 of the pharmaphorum podcast in the player below, download the episode to your computer or find it – and subscribe to the rest of the series – in iTunes, Spotify, acast and Stitcher.
AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo. The trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without type-2 diabetes. The safety profile of Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "With the DAPA-HF trial, Farxiga becomes the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without type-2 diabetes, on top of standard of care. Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalisation. We look forward to discussing the results of DAPA-HF with health authorities as soon as possible."