AstraZeneca Advances Pipeline with Sone Ve Phase III Win, Ultomiris FDA Filing, and More

AstraZeneca reported a wave of clinical and regulatory milestones across its oncology, rare disease, and metabolic portfolios, including positive Phase III results for sonesitatug vedotin in gastric cancer, an FDA priority review for Ultomiris in IgA nephropathy (IgAN), and a new FDA approval for Enhertu in breast cancer.

Sonesitatug vedotin, being developed by KYM Biosciences, a joint venture between Keymed Biosciences and Lepu Biopharma, in collaboration with AstraZeneca, produced a clinically meaningful improvement in overall survival compared with standard chemotherapy in a global Phase III trial for patients with Claudin 18.2-positive advanced or metastatic gastric cancer. The study achieved its primary overall-survival endpoint among patients receiving third-line or later treatment and met a key secondary overall-survival endpoint across patients receiving second-line or later treatment. The drug did not produce a statistically significant result for its other primary endpoint of progression-free survival, although an improving trend was reported. The treatment was well tolerated and produced no new safety concerns during the study. AstraZeneca estimated that the drug could eventually generate peak annual sales between $3 billion and $5 billion.

AstraZeneca also announced that the FDA has accepted a regulatory filing seeking to expand the use of Ultomiris (ravulizumab) for immunoglobulin A nephropathy (IgAN), a rare progressive kidney disease. The filing was granted priority review, shortening the review period by four months, with a final decision expected in the fourth quarter of 2026. If approved, Ultomiris would be the first C5 complement inhibitor available for IgAN. The drug is currently approved in the United States, Europe and Japan across four indications: atypical haemolytic uraemic syndrome, generalized myasthenia gravis, neuromyelitis optica spectrum disorder and paroxysmal nocturnal haemoglobinuria. The filing is supported by interim data from the late-stage I CAN study, which showed a 43.4% reduction in proteinuria compared with placebo after 34 weeks of treatment. In first-quarter 2026, Ultomiris generated $1.27 billion in sales, up 18% year over year. Separately, AstraZeneca shared mixed data for Ultomiris in post-stem cell transplant thrombotic microangiopathy, with benefit seen in paediatric patients but the adult trial not meeting its primary endpoint.

At the 2026 American Society of Clinical Oncology Annual Meeting, AstraZeneca presented Phase III results from the EMERALD-3 trial showing that the STRIDE regimen — a combination of IMFINZI (durvalumab) and IMJUDO (tremelimumab-actl) — plus lenvatinib and transarterial chemoembolization (TACE) significantly delayed disease progression in patients with unresectable liver cancer. The combination reduced the risk of disease progression or death by 30% compared with TACE alone, with median progression-free survival of 13.0 months versus 9.8 months. A second arm evaluating STRIDE plus TACE without lenvatinib also improved progression-free survival, with a median of 12.9 months versus 8.1 months for TACE alone. The overall survival hazard ratio was 0.84 compared with TACE alone, an encouraging trend that did not meet statistical significance at this interim analysis. Grade 3 or higher adverse events occurred in 71.4% of patients receiving the full combination, 64% of patients receiving STRIDE plus TACE, and 28.6% of patients treated with TACE alone. The trial remains ongoing and will continue to evaluate overall survival and other secondary endpoints. The results build on AstraZeneca’s previous HIMALAYA Phase III study, which helped establish the STRIDE regimen as a treatment option in advanced hepatocellular carcinoma.

In metabolic disease, AstraZeneca is advancing its oral GLP-1 receptor agonist elecoglipron to a Phase III clinical program following positive results from the VISTA and SOLSTICE Phase IIb trials. In the VISTA study, adults with obesity or overweight achieved 11.8% weight loss at 36 weeks, while the SOLSTICE trial showed a 1.9% reduction in HbA1c for adults with type 2 diabetes at 26 weeks. The safety profile was consistent with the GLP-1 class, with mostly mild to moderate gastrointestinal adverse events. The expanded Phase III program includes the EMBOLD and ELUMINATE trials, which will evaluate elecoglipron as both a monotherapy and in combination with other treatments, including long-term cardiovascular and kidney health outcomes.

The FDA also granted another approval for Enhertu in a breast cancer indication, broadening use of the targeted antibody-drug conjugate developed in partnership with Daiichi Sankyo. In addition, the Committee for Medicinal Products for Human Use in the European Union recommended approval of Datroway as a first-line treatment for certain breast cancer patients. SOPHiA GENETICS and AstraZeneca have entered a global partnership to develop and launch two decentralized companion diagnostics in precision oncology, linking AstraZeneca's oncology drugs to assays that can run in a wider range of hospitals rather than only central labs. AstraZeneca also entered a strategic collaboration with Abbisko Therapeutics to jointly advance a novel immunotherapy and tyrosine kinase inhibitor combination therapy for non-small cell lung cancer, and signed a deal with China's CSPC Pharmaceutical Group valued at up to $1.77 billion for exclusive global rights to a preclinical small nucleic acid drug candidate and ex-China rights to a second experimental therapy, both targeting renal diseases.

Financially, AstraZeneca reported first-quarter 2026 revenue of $15.29 billion, up 13% year over year, with Imfinzi sales of $1.69 billion (up 34%) and Enhertu sales of $831 million (up 40%). Core EPS rose 4% to $2.58, reflecting a higher core tax rate of 21% versus 16% in the prior year. Management reaffirmed full-year 2026 guidance for mid-to-high single-digit revenue growth and low double-digit Core EPS growth at constant exchange rates, alongside a long-term ambition of $80 billion in revenue by 2030. The company expects more than 20 Phase III readouts in 2026; four positive readouts were delivered in the first quarter, including tozorakimab in three Phase III COPD trials and Imfinzi in EMERALD-3, as well as a 53% reduction in invasive disease recurrence for Enhertu in the DESTINY-Breast05 trial.

Setbacks include an FDA delay on the experimental breast cancer drug camizestrant following a negative 6–3 advisory committee vote, the failure of the CARES Phase III program for anselamimab to meet its primary endpoint in light chain amyloidosis, and the Ceralasertib LATIFY Phase III failure. Brilinta fell 65% in the first quarter on generic competition, Soliris faces biosimilar pressure, and Forxiga patents were invalidated in the UK. AstraZeneca also agreed to pay a $34 million settlement on June 29, 2026, to resolve a Texas Medicaid fraud lawsuit alleging an illegal kickback scheme.