Three major drugmakers disclosed missed primary endpoints within days of each other in September 2026 — here’s what went wrong, who it affects, and what it signals about pharma R&D.
Results from the AstraZeneca Enhertu DESTINY-Lung04 Trial show a 37% reduction in risk of disease progression or death, establishing first-line efficacy for T-DXd in HER2-mutant non-small cell lung cancer.
AstraZeneca’s Phase III SERENA-4 trial of Etcamah (camizestrant) plus palbociclib missed statistical significance for progression-free survival in first-line advanced ER-positive breast cancer, though a numerical benefit was observed. The company says the miss sharpens its focus on ESR1-mutation-driven use of Etcamah under its existing SERENA-6 approval, with safety unchanged from each medicine’s known profile.
Amgen’s Phase 3 DeLLphi-305 trial shows the IMDELLTRA Imfinzi combination delivers a statistically significant, clinically meaningful overall survival benefit as first-line maintenance therapy in extensive-stage small cell lung cancer, alongside gains in progression-free survival and response rate.
AstraZeneca’s Etcamah (camizestrant) has won US FDA approval alongside CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation before disease progression.
The European Commission has approved Enhertu plus pertuzumab as a first-line treatment for HER2-positive metastatic breast cancer, marking AstraZeneca and Daiichi Sankyo’s first new EU regimen in this setting in over a decade, backed by DESTINY-Breast09 data showing a 44% reduction in progression or death risk.
Amgen and AstraZeneca announced that TEZSPIRE (tezepelumab-ekko) achieved statistically significant and clinically meaningful results across both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with benefits sustained through week 52.
AstraZeneca has officially stopped its Phase III eVOLVE-Lung02 trial evaluating volrustomig plus chemotherapy in first-line metastatic NSCLC following a recommendation from the Independent Data Monitoring Committee.
AstraZeneca’s H1 2026 results show Total Revenue climbing 9% to $30,672 million and Core EPS up 12% to $5.21, powered by Oncology and Rare Disease growth, 30 new regulatory approvals, and fresh licensing deals for Zegfrovy and TQC3721 — as the company reaffirms its $80 billion 2030 revenue ambition.
AstraZeneca has secured exclusive worldwide rights to Zegfrovy (sunvozertinib), Dizal Pharmaceutical’s oral EGFR inhibitor for EGFR exon 20 insertion non-small cell lung cancer, in a deal worth up to $1.5 billion. The agreement strengthens AstraZeneca’s EGFR-mutated lung cancer portfolio ahead of potential first-line expansion.
