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AstraZeneca PLC on Friday presented a slew of positive trial data on cancer drugs Enherto and Imfinzi at the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific program.
This included detailed results from the Destiny-Gastric01 phase 3 trial randomised controlled trial of Enhertu, the brand name for trastuzumab deruxtecan, in HER2-positive metastatic gastric cancer. Changes to the HER2 gene are associated with tumour growth.
These results showed that the drug "demonstrated a statistically significant and clinically meaningful improvement in objective response rate and overall survival" compared to chemotherapy.
The overall response rate was found to be 43% compared to 13% with chemotherapy. In total, 10 complete responses and 41 partial responses were seen in patients with Enhertu compared to no complete responses and 7 partial responses in chemotherapy patients.
Furthermore, patients treated with Enhertu had a 41% reduction in risk of death compared to chemotherapy.
FTSE 100-listed pharmaceutical company Astra is developing Enhertu along with Japanese peer Daiichi Sankyo Co Ltd.
Another trial, Destiny-CRC01, in HER2-positive metastatic colorectal cancer, found that Enhertu achieved a 45.3% tumour response rate. Objective response rate was the primary endpoint.
Destiny-CRC01 was a phase 2 trial in advanced colorectal cancer patients who had received at least two previous lines of standard treatment. Median progression-free survival was 6.9 months.
In HER2-mutant advanced non-small cell lung cancer, Enhertu "demonstrated meaningful clinical activity" according to interim analysis of Astra's phase 2 Destiny-Lung01 trial. The primary endpoint was overall response rate, which was found to be 62%.
For Imfinzi, the brand name for durvalumab, a phase 3 trial found that the drug - when combined with chemotherapy, etoposide plus either carboplatin or cisplatin - produced a sustained and clinically meaningful overall survival benefit. The Caspian trial was of adults with extensive-stage small cell lung cancer.
Caspian met is primary endpoint back in June 2019, reducing risk of death by 27%. This was the basis of the US Food & Drug Administration's approval for the drug in March 2020.
Following a media follow up of over two years, the most recent results shows that efficacy has been maintained, with patients continuing to have a 25% reduction in risk of death compared to just chemotherapy. The median overall survival was 12.9 months compared to 10.5 months with chemotherapy alone.
Around 22% of patients who had been treated with Imfinzi plus chemotherapy were still alive at 24 months versus 14% with chemotherapy alone. Of those patients treated with Imfinzi plus chemotherapy, 11% were alive and progression-free compared to 2.9% with just chemotherapy.
In another Imfinzi trial, Study 22, found "promising clinical activity and tolerabilit
AstraZeneca PLC on Tuesday announced a collaboration with genomic analysis company ArcherDX focused on minimal residual disease detection in early-stage non-small-cell lung cancer.
The collaboration will focus on Astra's newly launched phase 3 Mermaid-1 trial of Imfinzi plus chemotherapy versus just chemotherapy in patients with completely resected stage 2 and 3 non-small cell lung cancer who are a high risk of relapse. The primary endpoint is disease-free survival with evidence of minimal residual disease.
Drug maker Astra explained that the collaboration will involve using personalised cancer monitoring to detect minimal residual disease - minimal residual disease being the "very small number of otherwise undetectable cancer cells that shed circulating tumour DNA (ctDNA) in the blood".
ArcherDX will sequence the whole exome of patient samples to create personalised ctDNA assays which will be able to test for minimal residual disease remaining after successful surgery.
Jose Baselga, executive vice president of Oncology R&D at Astra, said: "While detecting and monitoring for minimal residual disease has proven challenging in solid tumours, the Mermaid-1 trial and this partnership stand to break new ground in lung cancer. This innovative endeavour is reflective of our strategy to improve cancer outcomes by treating patients as early as possible. It is in this early setting that the chance of cure is higher and identifying personalised, effective treatments could increase survival and improve quality of life."
Imfinzi is currently being tested in lung cancer, with a number of ongoing phase 3 trials in earlier stages of non-small cell lung cancer.
AstraZeneca shares were down 1.3% at 8,878.00 pence in London on Tuesday morning.
By Anna Farley; annafarley@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
AstraZeneca jumps on lung cancer drug data
May 28, 2020 6:33 PM ET|About: AstraZeneca PLC (AZN)|By: Carl Surran, SA News Editor
AstraZeneca (NYSE:AZN) +5.4% after-hours after saying its Tagrisso drug "demonstrated unprecedented patient benefit in the adjuvant treatment of EGFR-mutated lung cancer" in a Phase 3 trial.
AstraZeneca says treatment with Tagrisso in early-stage lung cancer patients cut the risk of lung cancer death or disease recurrence by ~80%, according to the study.
Tagrisso is AZN's top product, with $982M in sales during Q1, and the company says 60K additional patients may be eligible for treatment if the drug is approved in early-stage, post-surgical lung cancer.
(Alliance News) - AstraZeneca PLC on Thursday said it will begin first deliveries of the University of Oxford's Covid-19 vaccine in September and has received over USD1 billion from the US Biomedical Advanced Research & Development Authority.
The money from BARDA will go towards development, production and delivery of the vaccine beginning in autumn. Astra's development programme includes a phase 3 trial involving 30,000 participants as well as a paediatric trial.
The FTSE 100-listed drug maker is working with the UK government to support the Oxford University vaccine and will supply this vaccine to the UK beginning September.
First agreements for at least 400 million doses have been concluded, with Astra securing total manufacturing capacity for 1 billion doses so far.
"AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine," the company added.
Astra is speaking with international organisations, such as the Whorld health Organisation, the Coalition for Epidemic Preparedness Innovations, and Gavi the Vaccine Alliance to ensure "the fair allocation and distribution of the vaccine around the world". It is also in talks with governments to increase vaccine access and with the Serum Institute of India plus other partners to increase distribution and production.
The company has finalised its licence agreement with Oxford University for the vaccine, which was known as ChAdOx1 nCoV-19 but has now been named AZD1222. This follows the recent signing of a global development and distribution agreement with Oxford Vaccine Group and the university's Jenner Institute.
Astra also will support the establishment of a joint research centre at Oxford University, which will conduct "pandemic preparedness research".
A phase 1/2 UK clinical trial of AZD1222 started in April looking at the vaccine's safety, efficacy, and immunogenicity - immunogenicity in this case being the ability of the vaccine to create and immune response.
In total, more than 1,000 healthy volunteers took part in this phase 1/2 trial, with data due shortly. A positive results would then lead to late-stage trials in a number of countries.
AstraZeneca said it "recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk".
This news is not expected to materially impact Astra's 2020 financial guidance, with the expense of progressing the vaccine likely offset by government funding.
Chief Executive Pascal Soriot said: "This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world. We are so proud to be collaborating with Oxford University to turn their g
Thats what I though at £84 and sold 10% of my holding. The fact that I still hold the balance gives me a 90% share of the upside
“Nobody rings a bell at the top or the bottom of a market” (Wall Street proverb)
The Wall Street proverb appears to date back to around 1900. The proverb, like the bell, is still in use today.
AZN is one of my core holdings. I have held them almost for ever.
That said I have just sold about 10% of my AZN shares. The price looks stratospheric so I decided to take a little bit of the profit.
My aim will be to buy back if the price falls back.
Maxim: Never wrong to take a profit.
Abbott Labs (NYSE:ABT) just launched its third Covid-19 test. That adds to its molecular lab-based test and its rapid point-of-care test already in use. The new one will be a blood test, which is set to ship 1 million kits this week and 4 million this month. By June, the company expects to supply enough screening to produce 20 million samples.
£2.5 billion through bond offering
"I have never heard of any vaccine having side effects."
Try reading the pack insert for the vaccine.
eg
The most common adverse reactions, reported in >10% of subjects vaccinatedwithPNEUMOVAX23inclinicaltrials,were:injection-site pain/soreness/tenderness (60.0%), injection-site swelling/induration (20.3%), headache (17.6%), injection-siteerythema (16.4%), asthenia and fatigue (13.2%), and myalgia (11.9%). (6.1)
THIS ISN'T A REASON NOTTO VACCINATE!
AstraZeneca PLC and Merck & Co Inc on Tuesday said the US Food & Drug Administration has approved Koselugo, or selumetinib, for the treatment of neurofibromatosis type 1 in patients two years of age and older.
Neurofibromatosis type 1 is a genetic condition that causes tumours to grow along nerves.
Pharmaceutical partners AstraZeneca and Merck said the approval by the regulatory authority was based on positive results from Sprint Phase II Stratum 1 trial. When treated with selumetinib as a twice-daily oral monotherapy, 66% of paediatric patients with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas saw at least a 20% reduction in tumour volume.
The drug is now the first medicine indicated for the treatment of paediatric patients with neurofibromatosis type 1 plexiform neurofibromas, AstraZeneca said.
"Previously there were no medicines approved for this disease. This approval has the potential to change how symptomatic, inoperable NF1 plexiform neurofibromas are treated and provides new hope for these patients," said Roy Baynes, chief medical officer of Merck's Research Laboratories.
Separately, AstraZeneca said its Adaura Phase III trial for Tagrisso, or osimertinib, for the treatment of lung cancer showed positive results.
For three years, the trial assessed Tagrisso as a first-line treatment for "patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer". The trial will now continue to assess its secondary endpoint of overall survival.
"We are thrilled by the recommendation to unblind the Phase III Adaura trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure," said Jose Baselga, executive vice president, Oncology R&D.
AstraZeneca shares in London were up 5.7% at 7,525.21 pence each on Thursday morning. Merck shares ended 2.3% lower on Monday at USD80.54 in New York, with down 0.3% at USD80.33 in Tuesday's pre-market trading.
By Ife Taiwo; ifetaiwo@alliancenews.com