Ultime notizie per AstraZeneca (NASDAQ:AZN) Azioni

AstraZeneca

A merger between Astra of Sweden and Zeneca Group of the United Kingdom formed AstraZeneca in 1999. The firm sells branded drugs across several major therapeutic classes, including gastrointestinal, diabetes, cardiovascular, respiratory, cancer, immunology and rare diseases. The majority of sales come from international markets with the United States representing close to one third of its sales.

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AstraZeneca PLC

ASTRAZENECA ORD

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On Thursday, the FDA accepted and granted Priority Review to AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental marketing application for Calquence (acalabrutinib) for adult patients with previously untreated <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/b41160742/calquence-acalabrutinib-granted-priority-review-in-the-us-for-patients-with-untreated-mantle-cell-" rel="noreferrer noopener">mantle cell lymphoma (MCL)</a>.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.
MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), resulting when B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41050339/astrazenecas-top-selling-cancer-drug-tagrisso-receives-fda-green-light-for-another-lung-cancer-in" rel="noreferrer noopener">AstraZeneca&#8217;s Top-Selling Cancer Drug Tagrisso Receives FDA Green Light For Another Lung Cancer Indication</a>.
It is estimated that more than 27,500 people are living with MCL worldwide.
Results from the <a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca-us.com%2Fmedia%2Fpress-releases%2F2024%2Fcalquence-acalabrutinib-plus-chemoimmunotherapy-reduced-the-risk-of-disease-progression-or-death-by-27-percentage-vs-standard-of-care-in-patients-with-untreated-mantle-cell-lymphoma-in-echo-phase-iii-trial.html&amp;esheet=54130935&amp;newsitemid=20241003958806&amp;lan=en-US&amp;anchor=ECHO+Phase+III+trial&amp;index=1&amp;md5=3837bcbd9ded15f0ec3b2c2476b8d102" rel="noreferrer noopener">ECHO Phase III trial</a> recently were presented during the late-breaking oral session at the European Hematology Association (EHA) 2024 Hybrid Congress.
In the trial, Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care (SoC) chemoimmunotherapy.
Adding Calquence to SoC provided almost 1.5 years of additional median progression-free survival (mPFS) with mPFS of 66.4 months for patients treated with the Calquence combination versus 49.6 months with SoC.
Overall survival (OS) showed a favorable trend for the Calquence combination compared to SoC chemoimmunotherapy.
The OS data were not mature during this analysis, and the trial will continue to assess OS as a key secondary endpoint.
The ECHO trial was conducted during the COVID-19 pandemic. After censoring COVID-19 deaths, the PFS was further improved in both arms, with the CALQUENCE combination reducing the risk of disease progression or death by 36%. A favorable trend was seen for OS in this analysis for the Calquence combination, but OS data were not mature.
Price Action: AZN stock is down 1.73% at $78.21 at last check Thursday.
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AstraZeneca Seeks Expanded Use For Blood Cancer Drug Calquence, FDA Grants Priority Review

The FDA Has Accepted And Granted Priority Review AstraZeneca's Supplemental New Drug Application For Calquence (Acalabrutinib) For Previously Untreated Mantle Cell Lymphoma, The FDA Action Date Is Anticipated During Q1 Of 2025

RCUS

Arcus Biosciences Announces Clinical Trial Collaboration Agreement With AstraZeneca To Evaluate Casdatifan In Combination With Volrustomig In Renal Cell Carcinoma

Monday, the U.S. Department of Health and Human Services (HHS) announced that Medicare enrollees will benefit from reduced prices on 54 drugs through Medicare Part B, effective from October 1, 2024, to December 31, 2024.
The <a target="_blank" href="https://www.hhs.gov/about/news/2024/09/30/hhs-announces-cost-savings-for-prescription-drugs-thanks-to-medicare-inflation-rebate-program.html" rel="noreferrer noopener">program</a> aims to counter drug price hikes that exceed inflation, providing financial relief for over 822,000 Medicare beneficiaries who rely on these medications to treat conditions like cancer, osteoporosis, and pneumonia.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422798/doctors-struggle-to-secure-medicare-coverage-for-heart-patients-on-novo-nordisks-wegovy" rel="noreferrer noopener">Doctors Struggle to Secure Medicare Coverage for Heart Patients on Novo Nordisk&#8217;s Wegovy</a>
HHS Secretary Xavier Becerra emphasized that the Biden administration&#8217;s prescription drug policies are making a tangible impact on seniors and people with disabilities by reducing out-of-pocket costs.
According to Chiquita Brooks-LaSure, CMS Administrator, some Medicare beneficiaries could see daily savings ranging from $1 to as much as $3,854 on drugs included in the rebate program.
For example, a cancer patient using Novartis&#8217; AGs (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Kymriah could save up to $3,000.
Brooks-LaSure also noted that the law disincentivizes drug companies from raising prices faster than inflation, which helps protect Medicare beneficiaries from sharp price increases.
The Inflation Reduction Act&#8217;s initiatives extend beyond 2024. In August, the administration reached new agreements to reduce prices for ten additional high-cost drugs.
Once these prices take effect in 2026, Medicare is projected to save an estimated $6 billion, while beneficiaries could see a reduction of $1.5 billion in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40397706/biden-administration-targets-6b-savings-through-medicare-drug-price-negotiations" rel="noreferrer noopener">out-of-pocket expenses</a>.
Starting in 2025, Medicare Part D enrollees will further benefit from a $2,000 annual cap on prescription drug costs, down from the current cap of $3,500 for those with high expenses.
According to some analysts,&nbsp;Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>)&nbsp;blockbuster diabetes drug&nbsp;Ozempic might be included, along with several other well-known medications, in the next round of negotiations, which <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534249/novo-nordisks-ozempic-might-be-among-2027-medicare-price-negotiation-targets" rel="noreferrer noopener">is set for 2027</a>.
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Photo via Shutterstock

Government

Regulations

US HHS Reveal Cost Savings For 54 Prescription Drugs Including Novartis' Cancer Drug, Ozempic Could be Next

Daiichi Sankyo (TSE: 4568) and AstraZeneca's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental Biologics License Application (sBLA) for ENHERTU&#xAE; (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is February 1, 2025. The Priority Review follows receipt of Breakthrough Therapy Designation <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202408%2F20240819_E1.pdf&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=granted&amp;index=1&amp;md5=c82129aaf52e5fdfcdcfd5c5d0f72567">granted</a> by the FDA for ENHERTU based on data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04494425&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=DESTINY-Breast06&amp;index=2&amp;md5=ecfc5698cd40f1242f214ba893845e59">DESTINY-Breast06</a> phase 3 trial in August 2024.
Hormone receptor (HR) positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.1 Despite being classified as HER2 negative, many of these tumors still carry some level of HER2 expression.2 It is estimated that up to 85% to 90% of tumors historically classified as HR positive, HER2 negative, may be HER2 low or HER2 ultralow.3,4
The sBLA is based on data from DESTINY-Breast06 <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202406%2F20240602_E2.pdf&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=presented&amp;index=3&amp;md5=60d743b75d92125e38563f950191d661">presented</a> as a late-breaking oral session at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and recently published in <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.nejm.org&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=The+New+England+Journal+of+Medicine&amp;index=4&amp;md5=1e3a45484df713407df2ad6cdbca0eba">The New England Journal of Medicine</a>. In the overall trial population, ENHERTU reduced the risk of disease progression or death by 37% by blinded independent central review (BICR) versus chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI]: 0.53-0.75; p&lt;0.0001). Median progression-free survival (PFS) was 13.2 months with ENHERTU compared to 8.1 months with chemotherapy.
Results were consistent in patients with HER2 low expression and HER2 ultralow expression. In the primary endpoint analysis of patients with HR positive, HER2 low metastatic breast cancer, median PFS was 13.2 months in the ENHERTU arm compared to 8.1 months in the chemotherapy arm (HR 0.62; 95% CI: 0.51-0.74; p&lt;0.0001), as assessed by BICR. In a prespecified exploratory analysis of patients with HER2 ultralow expression, ENHERTU showed a median PFS of 13.2 months versus 8.3 months, respectively (HR 0.78; 95% CI: 0.50-1.21).
The safety profile of ENHERTU in DESTINY-Breast06 was consistent with previous breast cancer clinical trials with no new safety concerns identified. The most common grade 3 or higher treatment related treatment emergent adverse events (TEAEs) occurring in 5% or more of patients treated with ENHERTU were neutropenia (20.7%), leukopenia (6.9%) and anemia (5.8%). Interstitial lung disease (ILD) or pneumonitis occurred in 11.3% of patients treated with ENHERTU. The majority of ILD or pneumonitis events were low grade (grade 1 [n=7; 1.6%] or grade 2 [n=36; 8.3%]). There were three grade 3 ILD events (0.7%), zero grade 4 events and three grade 5 events (0.7%) as determined by an independent adjudication committee.
"This Priority Review highlights the potential to expand the existing indication of ENHERTU in HER2 low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2 ultralow," said Ken Takeshita, MD, Global Head, R&amp;D, Daiichi Sankyo. "We look forward to working closely with the FDA with the goal of bringing ENHERTU to more patients as quickly as possible."
"While endocrine therapies are widely used in the initial treatment of HR positive metastatic breast cancer, most patients see limited benefit with additional lines of treatment and subsequent chemotherapy is associated with poor response rates and outcomes," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&amp;D, AstraZeneca. "The results from DESTINY-Breast06 show that ENHERTU has the potential to evolve the current HR positive treatment landscape and become the first targeted treatment for patients with HER2 low or HER2 ultralow expression following endocrine therapy."

FDA Grants Priority Review for Daiichi Sankyo and AstraZeneca's ENHERTU in Breast Cancer Treatment

Thursday, the FDA approved AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Tagrisso&nbsp;(osimertinib)​ for adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).&nbsp;
Tagrisso&nbsp;is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40977596/latest-trial-setback-for-astrazenecas-dato-dxd-the-drug-fails-to-extend-lives-of-pretreated-breas" rel="noreferrer noopener">Latest Trial Setback For AstraZeneca&#8217;s Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients</a>.
Tagrisso is AstraZeneca&#8217;s top-selling cancer drug, and in the second quarter of 2024, it generated around <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39958623/astrazeneca-posts-mixed-q2-earnings-still-raises-annual-guidance-on-strong-demand-for-cancer-rare" rel="noreferrer noopener">$1.6 billion in sales</a>.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-us-approval-in-unresectable-lung-cancer.html" rel="noreferrer noopener">approval</a> follows the FDA&#8217;s&nbsp;Priority Review based on results from the LAURA Phase 3 trial.
Tagrisso&nbsp;reduced the risk of disease progression or death by 84% compared to placebo.
Median progression-free survival (PFS) was 39.1 months in patients treated with&nbsp;Tagrisso&nbsp;versus 5.6 months for placebo.&nbsp;
Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.
Each year in the US, there are more than 200,000 people diagnosed with lung cancer, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.
Approximately 15% of NSCLC patients in the US have EGFR mutations. Nearly one in five people diagnosed with NSCLC has an unresectable tumor.
The safety and tolerability of&nbsp;Tagrisso&nbsp;in the LAURA trial was consistent with its established profile and no new safety concerns were identified.
Tagrisso is approved for patients with EGFR mutations in the first-line metastatic setting as monotherapy, in combination with chemotherapy, and as an adjuvant treatment for early-stage disease.&nbsp;
Last week, the FDA approved&nbsp;AstraZeneca&#8217;s Fasenra&nbsp;(bevacizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can damage<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40923602/astrazenecas-asthma-drug-gets-fda-approval-for-rare-disease-of-blood-vessel-inflammation" rel="noreferrer noopener"> multiple organs</a>.
Price Action: AZN stock is up 0.94% at $78.27 at the last check Thursday.
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Image by Robert Way via Shutterstock

AstraZeneca's Top-Selling Cancer Drug Tagrisso Receives FDA Green Light For Another Lung Cancer Indication

FDA Approves Osimertinib For Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer After Chemoradiation Therapy; Recommended Dose Is 80mg Daily Until Disease Progression Or Unacceptable Toxicity

Monday, Black Diamond Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BDTX#NASDAQ">BDTX</a>) reported initial Phase 2 <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40976802/black-diamond-therapeutics-announces-initial-phase-2-data-demonstrating-robust-anti-tumor-activity" rel="noreferrer noopener">data of BDTX-1535</a>.
The data demonstrated encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor (EGFR)-mutant (EGFRm) non-small cell lung cancer (NSCLC).
&#8220;Patients often become resistant to osimertinib with the emergence of on-target resistance EGFR mutations,&#8221; said Sergey Yurasov, Chief Medical Officer of Black Diamond Therapeutics. &#8220;Our preliminary Phase 2 data demonstrate the potential of BDTX-1535 to deliver durable responses for these patients.&#8221;
AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) markets osimertinib as&nbsp;Tagrisso.
Preliminary response rate and durability were assessed in 27 patients at 200 mg with an August 17, 2024, data cutoff, including 22 response-evaluable patients who met protocol eligibility criteria.
The preliminary objective response rate (ORR) for the 22 response-evaluable patients was 36%. Nineteen of these 22 patients expressed known osimertinib resistance mutations.
Of these 19 patients, 8 achieved a response (42%): 5 with a confirmed partial response (PR), including one patient who converted from a PR to an unconfirmed complete response (CR) at 8 months (and awaits confirmatory scan); and 3 with an unconfirmed PR at first scan and awaiting a confirmatory scan. An additional 9 patients experienced stable disease.
Encouraging durability was observed, with a duration of response (DOR) of approximately 8 months or more for the first three patients with PR; 14 of 19 remain on therapy.&nbsp;Mean follow-up time is 4.7 months.
Most adverse events were mild or moderate, and no new safety signals were observed.
200 mg daily selected for pivotal clinical development.&nbsp;
Black Diamond continues to enroll patients in the second—and third-line cohorts and in the first-line setting for patients with non-classical EGFR mutations.
In Q1 2025, the company expects to disclose initial results from the first-line cohort and outline potential registrational paths in the recurrent setting based on FDA feedback.
Price Action: BDTX stock is up 2.21% at $4.86 at the last check on Monday.
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Movers

BDTX

Black Diamond Therapeutics' Lead Drug Candidate Shows Initial Anti-tumor Activity In Certain Type Of Lung Cancer Resistant To AstraZeneca's Drug

Monday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) released high-level results from the TROPION-Breast01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to the investigator&#8217;s choice of chemotherapy.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/datopotamab-deruxtecan-final-overall-survival-results-reported-in-patients-with-metastatic-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-breast01-phase-iii-trial.html" rel="noreferrer noopener">study</a> did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
The study previously met the dual primary endpoint of progression-free survival.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40793946/astrazeneca-ceo-pascal-soriot-updates-on-chinese-compliance-probe-and-lung-cancer-drug-trial-resu" rel="noreferrer noopener">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>.
An improvement in patient-reported outcomes was also seen.
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.
All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.
With multiple antibody-drug conjugates (ADCs) approved during the trial, including&nbsp;Enhertu (trastuzumab deruxtecan), subsequent treatment following patients&#8217; disease progression or treatment discontinuation is likely to have affected survival results.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo Ltd&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) and being jointly developed by AstraZeneca and Daiichi Sankyo.
Earlier this month, AstraZeneca&nbsp;shared detailed results from the TROPION-Lung01 Phase 3 of datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40791315/astrazenecas-investigational-cancer-drug-disappoints-in-late-stage-lung-cancer-trial" rel="noreferrer noopener">one prior line of therapy</a>.
In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance.
Friday, the FDA <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html" rel="noreferrer noopener">approved</a> AstraZeneca&#8217;s FluMist as the only self-administered influenza vaccine.&nbsp;
FluMist, a needle-free nasal spray, was approved for self-administration by adults up to 49 years of age or for parent/caregiver administration to individuals 2-17 years of age.
Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.
Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.
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Image by Robert Way via Shutterstock

DSKYF

DSNKY

Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients

The&nbsp;Committee for Medicinal Products for Human Use (CHMP)&nbsp;of the European Medicines Agency based its positive opinion on results from the MANDARA Phase III trial published in&nbsp;The New England Journal of Medicine, which compared the efficacy and safety of&nbsp;Fasenra&nbsp;to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA. Patients were randomized to receive either a single 30 mg subcutaneous injection of&nbsp;Fasenra, or three separate 100 mg subcutaneous injections of mepolizumab every four weeks.

AstraZeneca's Fasenra (Benralizumab) Has Been Recommended For Approval In The European Union As An Add-on Treatment For Adult Patients With Relapsing Or Refractory Eosinophilic Granulomatosis With Polyangiitis

Topline results from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05104866&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast01&amp;index=1&amp;md5=38bfe55b682fc21bfb63c9c96538d6dd">TROPION-Breast01</a> phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
This analysis follows the positive PFS results <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202310%2F20231023_E2.pdf&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=presented&amp;index=2&amp;md5=cff8252e7446c8d69a1c27fc9fce80e2">presented</a> at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS. An improvement in patient-reported outcomes was also seen.1 The PFS data and additional results for key secondary endpoints were published this month in the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fascopubs.org%2Fdoi%2F10.1200%2FJCO.24.00920&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=Journal+of+Clinical+Oncology&amp;index=3&amp;md5=e7ed20db0874315d5367f7b02d51353a">Journal of Clinical Oncology</a>.
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns identified. All grade interstitial lung disease (ILD) rates remained low with no new grade 3 or higher ILD events observed.
With ADCs approved during the course of the trial, including ENHERTU&#xAE; (trastuzumab deruxtecan), subsequent treatment following patients' disease progression or treatment discontinuation is likely to have affected survival results.
"Datopotamab deruxtecan has previously shown a statistically significant progression-free survival benefit in TROPION-Breast01, a result supported by multiple meaningful secondary measures including patient-reported outcomes," said Ken Takeshita, MD, Global Head, R&amp;D, Daiichi Sankyo. "We are proud to have brought forth a new standard of care for patients with metastatic breast cancer with ENHERTU and we remain committed to making datopotamab deruxtecan another potential option for patients who can benefit."
"The metastatic HR positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&amp;D, AstraZeneca. "Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting. We will continue discussions with regulatory authorities and apply insights from these results to our clinical development program for datopotamab deruxtecan in breast cancer."
The data will be presented at an upcoming medical meeting and shared with regulatory authorities currently reviewing applications for this indication.
In addition to TROPION-Breast01, Daiichi Sankyo and AstraZeneca are evaluating datopotamab deruxtecan alone and with immunotherapy as treatment for patients with triple negative or HR low, HER2 negative breast cancers in the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05374512&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast02&amp;index=4&amp;md5=01feaaff425affd80759eb06d8c92034">TROPION-Breast02</a>, <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05629585&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast03&amp;index=5&amp;md5=bb5bdbad13d3fdfbaf1635f870880f2a">TROPION-Breast03</a>, <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06112379&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast04&amp;index=6&amp;md5=191cffef0ab77f965d8b58af4ebbca39">TROPION-Breast04</a> and <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06103864&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast05&amp;index=7&amp;md5=0f12d2808ec2428fa29d6d8aabb36d6e">TROPION-Breast05</a> phase 3 trials.

Daiichi Sankyo and AstraZeneca's Datopotamab Deruxtecan Falls Short on Survival in Breast Cancer Trial

FLUMIST Receives Approval For Self-Administration In U.S.

<a href="https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html" title="https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html">https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html</a>

AstraZeneca Initiates Recruitment For Two New Phase III Trials Investigating SAPHNELO In Cutaneous Lupus Erythematosus (LAVENDER) And Idiopathic Inflammatory Myopathies (JASMINE)

JMP Securities initiated coverage on BeiGene Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BGNE#NASDAQ">BGNE</a>), noting the Chinese biotech firm as a &#8216;unique <a target="_blank" href="https://www.benzinga.com/quote/bgne" rel="noreferrer noopener">investment opportunity</a>.&#8217;
The company&#8217;s flagship drug, Brukinsa (zanubrutinib), is among the more recent BTK inhibitors to break into a global market projected to hit $12.2 billion by 2031. Three major players dominate this sector, with Johnson &amp; Johnson&#8216;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Imbruvica leading the charge, peaking at $8.7 billion in sales in 2021.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534057/cancer-medicines-from-merck-bristol-myers-and-beigene-in-question-as-fda-committee-to-discuss-lim" rel="noreferrer noopener">Cancer Medicines From Merck, Bristol Myers And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer</a>.
However, competition intensified when AstraZeneca Plc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Calquence and Brukinsa entered the market in 2017 and 2019, respectively.
Analyst Reni Benjamin&#8217;s confidence in Brukinsa emerging as a market leader is bolstered by an exclusive survey of 37 doctors, indicating that 80% plan to boost their use of Brukinsa due to its perceived safety and long-term <a href="https://www.benzinga.com/general/biotech/24/03/37560438/fda-conditionally-approves-expanded-use-of-beigenes-combination-drug-for-certain-type-of-blood-ca" target="_blank" rel="noreferrer noopener">effectiveness advantages</a>.
As Imbruvica&#8217;s popularity declines, Calquence and Brukinsa will capture a larger market share. By 2031, Brukinsa is expected to command 55% of the market, potentially generating global sales of $5.4 billion, the analyst adds.
Benjamin says Brukinsa is on track to generate over $2 billion for the company in 2024, with total revenues to reach $3.7 billion.
The analyst has initiated the coverage with a Market Perform rating and a <a target="_blank" href="https://www.benzinga.com/quote/BGNE/analyst-ratings" rel="noreferrer noopener">price target of $288</a>.
China ranks as the third-largest healthcare market globally, behind the U.S. and the EU, with expenditures reaching $1.2 trillion.
BeiGene, which offers 14 products in China through various U.S. partners, holds a significant position in this market. Despite limited visibility into China&#8217;s regulatory and commercial environment, BeiGene&#8217;s sales force has driven annual revenues from China to $1.1 billion.
However, JMP writes that the numbers can drop to $178 million by 2031 due to patent expirations unless additional therapeutics are licensed.
Price Action: BGNE stock is up 1.05% at $199.59 at last check Wednesday.
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Chinese Biotech BeiGene Labeled 'Unique Investment' As Analyst Confident In Lead Cancer Drug

The FDA approved on Wednesday AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Fasenra&nbsp;(benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html" rel="noreferrer noopener">approval</a> was based on data from the MANDARA Phase 3 trial published in&nbsp;The New England Journal of Medicine, which compared the efficacy and safety of&nbsp;Fasenra&nbsp;to the only approved EGPA treatment, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Nucala (mepolizumab).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40793946/astrazeneca-ceo-pascal-soriot-updates-on-chinese-compliance-probe-and-lung-cancer-drug-trial-resu" rel="noreferrer noopener">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
In the trial, nearly 60% of&nbsp;Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.
Data also showed 41% of&nbsp;Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).
The safety and tolerability profile for&nbsp;Fasenra&nbsp;in the MANDARA trial was consistent with the known profile of the medicine.
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra&nbsp;is the second biologic approved to treat this disease.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.
It is also approved in children and adolescents ages six and above in the U.S. and Japan.
Last month, the FDA approved&nbsp;AstraZeneca&#8217;s Imfinzi&nbsp;(durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39958623/astrazeneca-posts-mixed-q2-earnings-still-raises-annual-guidance-on-strong-demand-for-cancer-rare" rel="noreferrer noopener">lymphoma kinase rearrangements</a>.
AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.
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Photo: Shutterstock

AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation

The FDA Approves AstraZeneca's Fasenra (benralizumab) For Eosinophilic Granulomatosis With Polyangiitis

Updated results from the HIMALAYA Phase III trial showed AstraZeneca's IMFINZI&#xAE; (durvalumab) plus IMJUDO&#xAE;(tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment.
These results from HIMALAYA will be presented today at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain (presentation 947MO).
At five years of follow-up, this latest exploratory analysis showed that a single priming dose of IMJUDO added toIMFINZI, called the STRIDE regimen (Single Tremelimumab-actl Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI] 0.65-0.89). An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% for those treated with sorafenib.
In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response (DpR) showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib.
Lorenza Rimassa, MD, Associate Professor of Medical Oncology, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy and a lead investigator in the HIMALAYA trial, said: "Treatment with durvalumab plus tremelimumab-actl for patients with advanced liver cancer doubled the overall survival rate at five years, a significant survival advantage over sorafenib that has also become even more pronounced over time. These data reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease."
Sarah Manes, Liver Cancers Program Director at Global Liver Institute, said: "Reaching the five-year survival milestone is both clinically significant and emotionally meaningful for people with advanced liver cancer and their families. We are thrilled to see this progress in improving outcomes with new treatment options, bringing new hope for long-term survivorship to patients in our community."
Susan Galbraith, Executive Vice President, Oncology R&amp;D, AstraZeneca, said: "It is remarkable to see nearly 20 percent of patients with advanced liver cancer treated with the STRIDE regimen alive at five years compared to only about seven percent of patients living that long historically. This is a major step forward, setting a new survival benchmark. This underscores our commitment to following patients for the long term to help us better characterize the enduring clinical benefits of this innovative priming approach with an anti-CTLA-4 antibody added to PD-L1 blockade."

AstraZeneca's HIMALAYA Trial Highlights 5-Year Outcomes for AstraZeneca's Dual Therapy in Liver Cancer

First immunotherapy regimen before and after surgery to demonstrate statistically significant and clinically meaningful overall survival improvement in this setting
Positive results from the NIAGARA Phase III trial showed AstraZeneca&#39;s IMFINZI&reg;&nbsp;(durvalumab)in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC). Patients were treated with IMFINZIin combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by IMFINZIas adjuvant monotherapy.

Reported Sunday, AstraZeneca's IMFINZI Perioperative Regimen Reduced Recurrence Risk By 32% And Death Risk By 25% Versus Chemotherapy Alone In Bladder Cancer, Per NIAGARA Phase III Trial

<ul>
<li>Daiichi Sankyo and AstraZeneca's ENHERTU achieved a 61.6% progression-free survival rate at one year in patients with active or stable brain metastases in DESTINY-Breast12</li>
<li>Largest prospective trial of ENHERTU in this patient population</li>
</ul>

AstraZeneca And Daiichi Sankyo To Present Findings Of ENHERTU Showing Clinical Activity In Patients With HER2 Positive Metastatic Breast Cancer And Brain Metastases

<a href="https://www.moffitt.org/newsroom/news-releases/moffitt-cancer-center-announces-strategic-collaboration-with-astrazeneca-to-accelerate-oncology-cell-therapies/">https://www.moffitt.org/newsroom/news-releases/moffitt-cancer-center-announces-strategic-collaboration-with-astrazeneca-to-accelerate-oncology-cell-therapies/</a>
Moffitt Cancer Center announces today a strategic collaboration with AstraZeneca that aims to accelerate the development of cell therapies, specifically chimeric antigen receptor T cell &nbsp;(CAR T) and T cell receptor (TCR T) therapies.
Under this collaboration, AstraZeneca will have priority access to Moffitt's leading clinical environment and forge strong connections between physician-scientists to accelerate the investigation of novel cell therapies. &nbsp;
Advances in cell therapy, including CAR Ts and TCR Ts, are reshaping cancer care by offering potential new treatments for cancers with limited treatment options. The field has grown exponentially since the first CAR T therapies were approved in 2017. Moffitt was pivotal in the clinical trials that led to several FDA approvals for cell therapies and continues to grow its capabilities in this field, with an extensive network of cancer centers across the United States.
The collaboration aims to address cell therapy development challenges and expand cell therapies' reach to more patients in the United States and beyond. A key focus will be on advancing clinical studies to investigate cell therapies in solid tumors and further optimizing clinical operations to streamline and expedite the delivery of autologous cell therapies to patients.
"We are excited to collaborate with AstraZeneca to push the boundaries of what's possible in cancer treatment. By combining our clinical expertise with AstraZeneca's innovative pipeline of investigational cell therapies, global footprint and leadership in oncology, we aim to bring potential new cell therapies to patients faster and more efficiently," said&nbsp;<a href="https://www.moffitt.org/about-moffitt/executive-leadership/patrick-hwu-md/">Patrick Hwu, M.D.</a>, president and CEO of Moffitt.
"This collaboration will strengthen our connections with the Moffitt Cancer Center to accelerate the development of our autologous cell therapy pipeline as we strive to redefine cancer treatment for more people living with hematological and solid cancers," said Carsten Linnemann, Head of Oncology Cell Therapy Clinical Development, AstraZeneca.

'Moffitt Cancer Center Announces Strategic Collaboration With AstraZeneca To Accelerate Oncology Cell Therapies'

CytoSorbents spikes on FDA submission for DrugSorb-ATR

AstraZeneca's Enhertu application accepted by FDA with priority review

Lilly looking to test Zepbound as health maintenance drug: report

Bank of America Securities analyst Sachin Jain has reiterated their bullish stance on AZN stock, giving a Buy rating on September 30. Sachin Jain h...

AstraZeneca: Strong Sales and Robust Pipeline Underpin Buy Rating

Jefferies analyst Peter Welford maintained a Hold rating on AstraZeneca (AZN – Research Report) today and set a price target of £114.00. The compan...

AstraZeneca (AZN) Receives a Hold from Jefferies

U.S. tweaks 2025 Medicare price negotiation process

AstraZeneca supplemental NDA for Calquence accepted by FDA

BNY Mellon International Equity Fund Q2 2024 Commentary

Dianthus started at outperform by Oppenheimer on DNTH103 opportunity

Absci: AI-Driven Platform Could Establish Best-In-Class TL1A Drug Targeting Profile

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Press Releases

FLUMIST approved for self-administration in the US

Datopotamab Deruxtecan Final Overall Survival Results Reported in Patients with Metastatic HR Positive, HER2 Low or Negative Breast Cancer in TROPION-Breast01 Phase 3 Trial

Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

TAGRISSO® (osimertinib) approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Who Have Received at Least One Line of Endocrine Therapy

ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy

How Cosmos Health's Acquisition Of Almost 100-Year-Old Company, Adding To Capabilities Like Contract Manufacturing, Could Generate Over $10 Million In Annual Gross Profit

Arcus Biosciences Announces Clinical Trial Collaboration Agreement to Evaluate Casdatifan in Combination with Volrustomig in Renal Cell Carcinoma

CALQUENCE® (acalabrutinib) granted Priority Review in the US for patients with untreated mantle cell lymphoma

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