Enhertu slashed risk of disease progression or death by half compared to chemotherapy HER2-low breast cancer

AstraZeneca (LON:AZN) and Daiichi Sankyo’s (OTCMKTS:DSNKY) Enhertu (fam-trastuzumab deruxtecan-nxki) showed a dramatic survival benefit in the pivotal DESTINY-Breast04 Phase 3 study focused on a subset of breast cancer patients. The DNA topoisomerase I inhibitor improved median overall survival by more than six months compared to chemotherapy in the study. In addition, the drug met the primary endpoint of progression-free survival in the study, cutting the risk of disease progression or death by 49% compared to chemotherapy.

AstraZeneca reports that the therapy could potentially redefine treatment for roughly half of breast cancer patients.

The DESTINY-Breast04 study focused on previously-treated patients with HER2-low unresectable or metastatic breast cancer.

AstraZeneca notes that Enhertu is the first HER2-focused therapy to show a survival benefit in the patient demographic.

Enhertu met the primary endpoint of progression-free survival in patie…

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AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2.

“Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases,” said Hugo Fry, a former Sanofi executive who is CEO of RQ Bio.

“By combining our expertise and innovative excellence in core areas, we have created a smarter approach to antibody generation, making us uniquely positioned to deliver fast patient impact,” Fry said in a news release.

The agreement gives AstraZeneca an exclusive worldwide license to develop, manufacture and commercialize mAbs against SARS-CoV-2.

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patien…

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Emergent hid quality problems from FDA, House report concludes

A new Congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated.

Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in Emergent’s Bayview plant in Baltimore.

In particular, the House report concluded that Emergent workers removed quality-assurance “hold” tags from Johnson & Johnson vaccine batches before an FDA inspection.

The Bayview plant had served as the only U.S. manufacturing site for the J&J COVID-19 vaccine.

The report relies on internal communications from Emergent executives to determine whether the company attempted to elude government oversight.

It also noted that the FDA, J&J and AstraZeneca employees identified problems at the …

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AstraZeneca’s Farxiga met primary endpoint in Phase 3 heart failure trial 

AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study. 

First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney disease. 

AstraZeneca now says that data from the DELIVER and DAPA-HF Phase 3 studies show its efficacy in heart failure regardless of ejection fraction. 

In the two studies, the safety profile of Farxiga was consistent with prior data.

Farxiga’s biggest competitor is Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly, first approved in 2014 for type 2 diabetes. Jardiance now has two FDA indications related to heart failure.

Another competitor is the heart failure drug Entresto (sacubitril/valsartan) from Novartis, which had $2.8 billion in sales in …

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Imfinzi with chemotherapy gets FDA priority review for locally advanced or metastatic biliary tract cancer

AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC).

The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.

FDA has set a Prescription Drug User Fee Act date for the third quarter of 2022.

Roughly 23,000 people in the U.S. receive a BTC diagnosis annually. Of those, approximately 5% to 15% survive five years after diagnosis.

“People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca: “We are working close…

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AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA.

Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY).

The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.

Of the five breakthrough therapy designations for the drug, three are for breast cancer, while the other two are in lung and gastric cancers, respectively.

In particular, the designation covers adults who have received prior systemic therapy for metastatic breast cancer or who have experienced disease recurrence within six months of finishing adjuvant chemotherapy.

In addition, the designation specifies that patients with hormone receptor (HR) positive breast cancer have received or be inelig…

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AstraZeneca’s Evusheld offered strong protection against COVID-19 in Phase 3 study

In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo. 

The drug is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19. 

Evusheld won a EUA in December 2021.

The adults enrolled in the trial had an inadequate response to COVID-19 vaccination, an elevated risk of exposure to SARS-CoV-2 or both. Subjects were either obese, immunocompromised, had pre-existing health conditions such as heart failure or chronic kidney disease, or were 60 years of age or older. 

After receiving a single 300 mg intramuscular dose of Evusheld, concentrations of the drug remained elevated for six months after administration, according to a pharmacokinetic analysis. 

Th…

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Developing nations shun AstraZeneca’s COVID-19 vaccine 

A number of developing nations have refused tens of millions of doses of AstraZeneca’s COVID-19 vaccines, according to a report from Reuters.

The countries had received doses of the AstraZeneca vaccine from the COVAX initiative, a global project that focuses on ensuring equitable access to COVID-19 vaccines.

COVAX has distributed 1.4 billion shots to 144 nations to date.

Some countries that COVAX serves indicated a preference for vaccines with a longer shelf life than AstraZeneca’s COVID-19 vaccine.

Last week, COVAX and the African Union also declined to order vaccine doses from Moderna, according to Reuters.

AstraZeneca’s COVID-19 Vaxzevria has a shelf life of six months, but doses are sometimes delivered weeks before the expiration date, Reuters reported.

In related news, Japan recently canceled a purchase of 40 million doses of the AstraZeneca vaccine, according to The Japan Times.

The country has expressed a preference for…

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New CEO and CFO take over at bone-cutting robot maker AOT

AOT CEO Elmar Zurbriggen (right) and CFO Peter Oprandi with the company’s CARLO system [Photo courtesy of AOT]Advanced Osteotomy Tools (AOT) announced that Elmar Zurbriggen will become CEO and Peter Oprandi will become CFO effective tomorrow.

Basel, Switzerland-based AOT developed the world’s first certified surgical device to cut bone with a laser. The system is called CARLO, for Cold Ablation Robot-guided Laser Osteotome. 

“Elmar and Peter have both gained decades of experience as senior managers in the life science sector, working for global market leaders such as Johnson & Johnson, DePuy Synthes, AstraZeneca and Lonza,” AOT Chair Dr. Erich Platzer said in a news release. “We are delighted that they are now supporting AOT as CEO and CFO. Our goal is to improve patient care with innovative high-tech products. Elmar and Peter are exactly the right leaders for this.”

Get the full story at our sister site, Medical Design & Outsourcing.

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New CEO and CFO take over at bone-cutting robot maker AOT

AOT CEO Elmar Zurbriggen (right) and CFO Peter Oprandi with the company’s CARLO system [Photo courtesy of AOT]

Advanced Osteotomy Tools (AOT) announced that Elmar Zurbriggen will become CEO and Peter Oprandi will become CFO effective tomorrow.

Basel, Switzerland-based AOT developed the world’s first certified surgical device to cut bone with a laser. The system is called CARLO, for Cold Ablation Robot-guided Laser Osteotome. 

“Elmar and Peter have both gained decades of experience as senior managers in the life science sector, working for global market leaders such as Johnson & Johnson, Depuy Synthes, AstraZeneca and Lonza,” AOT Chair Dr. Erich Platzer said in a news release. “We are delighted that they are now supporting AOT as CEO and CFO. Our goal is to improve patient care with innovative high-tech products. Elmar and Peter are exactly the right leaders for this.” Read more

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AstraZeneca announces global R&D postdoctoral program for complex disease research

AstraZeneca (LON:AZN) is looking for final year MD or PhD students and postdoctoral researchers to reach out with ideas to speed drug discovery and development in the company’s core disease areas.

The company’s central focus areas include oncology; cardiovascular, renal and metabolism; and respiratory and immunology.

Candidates accepted into the program have a fully funded postdoctoral research position that gives them access to in-house expertise, access to AstraZeneca’s R&D facilities and support from a partnering university.

Researchers will also get access to compounds, tools and technologies and mentoring.

Sir Mene Pangalos, AstraZeneca’s executive vice president, biopharmaceuticals R&D highlighted the need to continue accelerating R&D. “Rapid progress in disease understanding, as well as scientific and technological advances are genuinely changing our expectations of what is possible,” Pangalos said. “We are delighted to la…

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Lynparza cut death risk by one-third in adjuvant treatment of germline BRCA-mutated high-risk early breast cancer

Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN).

Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer.

The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival benefit in early breast cancer, according to AstraZeneca.

AstraZeneca developed the drug with Merck & Co. (NYSE:MRK), a company known as MSD outside of the U.S.

The OlympiA study showed that olaparib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Patients in the study had received earlier local treatment and standard neoadjuvan…

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