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 positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of Tagrisso was consistent with its established profile. José Baselga, Executive Vice President, Oncology R&D said: "Today's positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming Tagrisso as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer."
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.
AstraZeneca PLC agreed to pay as much as $6 billion to buy into Daiichi Sankyo Co.'s promising medicine for lung and breast cancer, the drugmakers' second potential blockbuster oncology deal in two years. The news sent Daiichi shares jumping the most since March. The U.K. drugmaker will pay Daiichi $1 billion upfront to jointly develop and bring to market a cancer therapy in early clinical tests called DS-1062, the companies said Monday. As much as $5 billion in additional payments could follow, subject to regulatory and sales milestones. AstraZeneca is forging ahead to become a global oncology powerhouse, even as it works on a vaccine for the coronavirus pandemic.
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.