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AstraZeneca

Running coverage of AstraZeneca's pipeline readouts, approvals, deals and strategy shifts.

61 selectedRelated topicsDeals and financingClinical readoutsFDA

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41–60 of 61
Sep 1Tue
  1. N Engl J Med78

    Eplontersen for Transthyretin Amyloid Cardiomyopathy.

    Eplontersen, an antisense oligonucleotide that reduces hepatic transthyretin production, did not reduce cardiovascular death or recurrent cardiovascular events in transthyretin amyloid cardiomyopathy. In the phase 3 CARDIO-TTRansform trial, 1432 patients received subcutaneous eplontersen 45 mg or placebo every 4 weeks for 140 weeks; the primary composite occurred at a rate ratio of 0.89 (95% CI, 0.73 to 1.09; P = 0.28). The finding leaves no demonstrated outcome benefit for eplontersen on top of standard treatment in ATTR-CM.

    Why it matters: Negative phase 3 result for eplontersen in 1432 patients with ATTR-CM at 140 weeks.

Aug 30Sun
  1. nature.com59

    Eplontersen with and without background transthyretin stabilizers in transthyretin amyloid cardiomyopathy: secondary analysis of a phase 3, randomized controlled trial

    A secondary analysis of the CARDIOTTRansform phase 3 randomized controlled trial found that eplontersen, a transthyretin-targeting antisense oligonucleotide, benefited patients with transthyretin amyloid cardiomyopathy who were not on transthyretin stabilizers at baseline, but showed no such effect in those already taking stabilizers. The result separates responders from non-responders by background therapy. Findings were presented at the 2026 ESC Congress.

    Why it matters: It identifies baseline transthyretin stabilizer use as a factor determining which cardiomyopathy patients benefit from eplontersen.

Aug 29Sat
  1. biocentury.com67

    Can silencers add benefit in ATTR-CM?

    Eplontersen, co-developed by AstraZeneca and Ionis, missed the primary endpoint in the Phase III CARDIO-TTRansform trial in ATTR-CM. Detailed data show that among patients already on a TTR stabilizer at baseline, adding eplontersen led to worse outcomes than the stabilizer alone. The miss, announced in July, is a major setback for a planned future core revenue driver for both companies.

    Why it matters: Subgroup data showing worse outcomes with added eplontersen rule out combination use in patients already on TTR stabilizers.

Aug 26Wed
  1. mp.weixin.qq.com70

    Why AstraZeneca's Volrustomig Failed First-Line NSCLC Phase III eVOLVE-Lung02

    In August 2026, AstraZeneca announced it would discontinue eVOLVE-Lung02, a global Phase III study of the PD-1/CTLA-4 bispecific antibody Volrustomig plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer. In the primary analysis of the PD-L1 negative population, the regimen was unlikely to meet the dual primary endpoints of PFS and OS, and no new safety signals were found. The regimen was Volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy head to head.

    Why it matters: Reports negative results for Volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy, a reference for same-target bispecifics in first-line NSCLC.

Aug 20Thu
  1. mp.weixin.qq.com74

    AstraZeneca Discontinues Phase III eVOLVE-Lung02 of PD-1/CTLA-4 Bispecific Volrustomig in First-Line NSCLC

    AstraZeneca has discontinued the Phase III eVOLVE-Lung02 study of its PD-1/CTLA-4 bispecific antibody Volrustomig as first-line therapy for non-small cell lung cancer. After a pre-specified interim analysis, the independent data monitoring committee concluded the drug was almost certainly unable to beat the standard regimen of pembrolizumab plus chemotherapy in the PD-L1 negative population. The global, multicenter pivotal trial enrolled 895 patients and failed at its first readout.

    Why it matters: Provides a Phase III interim failure for a PD-1/CTLA-4 bispecific in first-line NSCLC, with the comparator regimen, as a reference for the same-target pipeline.

  2. mp.weixin.qq.com72

    AstraZeneca TSLP Monoclonal Antibody Wins Approval in China for Severe Asthma and Nasal Polyps

    China's regulator has approved AstraZeneca's human monoclonal antibody targeting TSLP for two indications at once: maintenance treatment of severe asthma in adults and adolescents over 12, and, with nasal corticosteroids, chronic rhinosinusitis with nasal polyps in adults inadequately controlled by systemic corticosteroids or surgery. It is the first severe asthma biologic in China unrestricted by phenotype or biomarker level and the first TSLP-targeting drug for CRSwNP.

    Why it matters: Dual approval of a first-in-class TSLP biologic for two respiratory indications in China.

Aug 19Wed
  1. mp.weixin.qq.com70

    AstraZeneca Terminates Late-Stage eVOLVE-Lung02 Trial of PD-1/CTLA-4 Bispecific Volrustomig

    AstraZeneca has terminated the global late-stage eVOLVE-Lung02 trial of the PD-1/CTLA-4 bispecific antibody Volrustomig combined with chemotherapy. The study compared Volrustomig plus chemotherapy head-to-head with pembrolizumab plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer with PD-L1 expression below fifty percent. AstraZeneca's other key bispecific is the PD-1/TIGIT antibody Rilvegostomig.

    Why it matters: The head-to-head trial versus pembrolizumab plus chemotherapy provides a negative control for same-target bispecifics in first-line NSCLC.

  2. mp.weixin.qq.com68

    AstraZeneca Stops Phase 3 eVOLVE-Lung02 of Volrustomig in PD-L1-Low Lung Cancer

    AstraZeneca has discontinued the global Phase 3 eVOLVE-Lung02 trial of the PD-1/CTLA-4 bispecific antibody volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy in PD-L1 <50% lung cancer. The independent data monitoring committee judged the study unlikely to meet either the OS or PFS primary endpoint. The author notes this follows the failure of KEYNOTE-598 as a second setback for the CTLA-4 pathway in this setting.

    Why it matters: A second Phase 3 failure for CTLA-4-based therapy in wild-type lung cancer affects AstraZeneca's bispecific pipeline.

Aug 18Tue
  1. mp.weixin.qq.com73

    AstraZeneca and HUTCHMED SAFFRON Trial Meets Dual PFS and OS Endpoints

    AstraZeneca and HUTCHMED jointly announced that the SAFFRON trial met its primary endpoint: Tagrisso plus Orpathys, compared with platinum-based doublet chemotherapy, achieved statistically significant and clinically meaningful improvements in both PFS and OS. The trial enrolled patients with locally advanced or metastatic NSCLC harboring EGFRm with high MET overexpression or amplification whose disease had progressed on Tagrisso.

    Why it matters: The SAFFRON trial met both PFS and OS endpoints, showing benefit over doublet chemotherapy in EGFRm NSCLC with high MET alterations after Tagrisso resistance.

  2. mp.weixin.qq.com69

    AstraZeneca Stops Late-Stage eVOLVE-Lung02 Trial of Volrustomig Plus Chemotherapy After Failure

    AstraZeneca announced it will terminate the late-stage eVOLVE-Lung02 trial, which evaluated volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer with PD-L1 expression below 50%. The safety profile was consistent with the known profiles of each agent alone, with no new safety signals identified. The company did not specify the reason for termination.

    Why it matters: The head-to-head failure against first-line pembrolizumab rules out volrustomig replacing or adding to standard therapy in this population.

  4. mp.weixin.qq.com74

    AstraZeneca PD-1/CTLA-4 Bispecific Volrustomig Misses Primary Endpoint in Frontline Lung Cancer Phase 3 eVOLVE-Lung02

    AstraZeneca announced on August 17 that the phase 3 eVOLVE-Lung02 trial of the PD-1/CTLA-4 bispecific volrustomig plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer did not meet its primary endpoints, and the company will stop the trial. Both co-primary endpoints of PFS and OS were not reached versus pembrolizumab plus chemotherapy.

    Why it matters: Head-to-head phase 3 versus pembrolizumab plus chemotherapy missed both PFS and OS, informing design of same-target bispecifics in frontline NSCLC.

  5. mp.weixin.qq.com72

    AstraZeneca Discontinues Phase III NSCLC Trial of PD-1/CTLA-4 Bispecific Volrustomig

    AstraZeneca has discontinued the Phase III eVOLVE-Lung02 trial of the PD-1/CTLA-4 bispecific antibody volrustomig, following a recommendation from an independent data monitoring committee after a planned review of trial data. The randomized, open-label, multicenter global Phase III trial enrolled 895 patients with metastatic NSCLC and PD-L1 expression below 50% across 25 countries, randomized 1:1 to volrustomig plus chemotherapy or pembrolizumab plus chemotherapy.

    Why it matters: The brief gives trial design, enrollment size and randomization; the bispecific's failure here can be compared with readouts from similar bispecifics.

  6. mp.weixin.qq.com78

    AstraZeneca and Daiichi Sankyo's Enhertu Phase III DESTINY-Lung04 Shows Positive First-Line Results in HER2-Mutant NSCLC

    AstraZeneca and Daiichi Sankyo announced on August 17 that the Phase III DESTINY-Lung04 study of Enhertu (trastuzumab deruxtecan) as monotherapy in the first-line treatment of HER2-mutant NSCLC met its primary endpoint of PFS.

    Why it matters: Enhertu monotherapy versus pembrolizumab plus platinum chemotherapy achieved a Phase III PFS benefit, setting a controlled benchmark for first-line ADC monotherapy in lung cancer.

  7. mp.weixin.qq.com76

    Enhertu DESTINY-Lung04 Phase 3 Shows Significant PFS Improvement as First-Line HER2-Mutant Nonsquamous NSCLC

    Daiichi Sankyo and AstraZeneca jointly announced that the DESTINY-Lung04 trial showed a statistically significant and clinically meaningful improvement in PFS with Enhertu (trastuzumab deruxtecan) as first-line treatment for HER2-mutant nonsquamous NSCLC, compared with a control of platinum and pemetrexed chemotherapy plus pembrolizumab.

    Why it matters: Gives top-line PFS results for Enhertu versus pemetrexed-platinum chemotherapy plus pembrolizumab as first-line HER2-mutant NSCLC data.

  8. mp.weixin.qq.com75

    AstraZeneca Stops Phase 3 eVOLVE-Lung02 as volrustomig Fails to Beat Pembrolizumab in First-Line Lung Cancer

    On August 17, 2026, AstraZeneca announced termination of the phase 3 eVOLVE-Lung02 study. The trial evaluated the PD-1/CTLA-4 bispecific antibody volrustomig (MEDI572) plus chemotherapy versus pembrolizumab as first-line lung cancer treatment, and was stopped early because the PFS and OS primary endpoints were not expected to be met.

    Why it matters: Head-to-head miss for volrustomig versus pembrolizumab gives a direct negative control for PD-1/CTLA-4 bispecifics in first-line lung cancer.

Aug 17Mon
  1. fiercepharma.com73

    AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure

    AstraZeneca announced that two phase 3 NSCLC trials met their primary endpoints: Enhertu, and Orpathys combined with Tagrisso. The same day, its PD-1/CTLA-4 bispecific antibody volrustomig failed in a phase 3 trial.

    Why it matters: Two phase 3 NSCLC positive readouts and one PD-1/CTLA-4 bispecific failure released the same day allow comparison of same-target candidates in low PD-L1 expression populations.

  2. fiercebiotech.com63

    AstraZeneca ends phase 3 lung cancer trial after bispecific falls short versus Keytruda

    AstraZeneca has stopped a phase 3 trial of volrustomig plus chemotherapy versus Keytruda plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer, on the recommendation of the Independent Data Monitoring Committee following its interim analysis.

    Why it matters: IDMC ended the PD-L1-negative NSCLC phase 3 for futility, showing the limits of a bispecific replacing PD-1 monotherapy.

Aug 5Wed
  1. mp.weixin.qq.com68

    AstraZeneca and Bristol Myers Squibb Hold Merger Talks Valuing Combined Company Near $400 Billion

    The Financial Times reported on August 2, citing sources, that AstraZeneca and Bristol Myers Squibb have held multiple rounds of merger talks over recent months. A combined company would be valued at roughly $400 billion, surpassing BMS's $74 billion acquisition of Celgene and AstraZeneca's $39 billion acquisition of Alexion to rank among the largest deals in pharmaceutical history.

    Why it matters: Talks between two top-ten pharma companies could produce one of the industry's largest mergers ever.

Aug 4Tue
  1. mp.weixin.qq.com69

    AstraZeneca and Bristol Myers Squibb Reported in Multiple Rounds of Merger Talks

    AstraZeneca and Bristol Myers Squibb have held multiple rounds of merger talks over recent months, according to a Financial Times report citing people familiar with the matter. The report describes a combined market value of $400 billion, which would make it the largest deal in pharmaceutical industry history. A transaction could be finalised soon, but the talks may also be delayed or fall apart.

    Why it matters: A possible AstraZeneca-Bristol Myers Squibb merger would be the largest pharmaceutical deal ever at a reported $400 billion.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org