Astrazeneca (NYSE:AZN) highlighted new clinical data across bladder, lung and gastric cancers at its ESMO 2026 investor event, including four presidential presentations that executives said support the company’s oncology growth strategy.
Dave Fredrickson, executive vice president of the company’s oncology business, said AstraZeneca presented data spanning 27 approved and potential medicines across more than 15 tumor types, including 38 oral presentations. The company emphasized programs involving antibody-drug conjugates, or ADCs, immunotherapy combinations and earlier-stage treatment approaches.
VOLGA bladder cancer results
Professor Thomas Powles of Barts Health NHS Trust discussed the VOLGA trial in cisplatin-ineligible or cisplatin-refusing patients with muscle-invasive bladder cancer. The study evaluated three cycles of neoadjuvant enfortumab vedotin plus durvalumab before surgery against a standard control arm.
Powles said the trial showed an event-free survival hazard ratio of 0.51 and an overall survival hazard ratio of 0.58 at a median follow-up of 23 months. He noted a two-year overall survival landmark of 78% and an investigator-assessed pathological complete response rate of 45% for the enfortumab vedotin-durvalumab regimen.
The study also included circulating tumor DNA analysis using whole-genome testing. Powles said 78% of patients were ctDNA-positive at baseline and that ctDNA clearance occurred in 60% of patients, with those patients showing better outcomes.
Grade 3 or 4 adverse events occurred in 30% of patients receiving the regimen, while 11% experienced immune-related toxicity, according to Powles. He said the safety profile was consistent with expectations and that the treatment did not appear to compromise patients’ ability to undergo surgery.
Powles described the regimen as a potential new standard of care, though he said physicians may debate whether some patients require more than three cycles of therapy. He also said ongoing studies are exploring whether some patients who achieve a clinical complete response could eventually avoid cystectomy.
EGFR-mutant lung cancer programs
Professor Yi-Long Wu of Guangdong Provincial People’s Hospital reviewed results from the SAFFRON and SANOVO trials of Tagrisso, or osimertinib, plus the MET inhibitor savolitinib.
In SAFFRON, which enrolled patients with EGFR-mutant lung cancer who developed resistance after EGFR-TKI treatment and had MET abnormalities, the Tagrisso-savutolinib combination produced median progression-free survival of 7.5 months, compared with 5.4 months for chemotherapy. Wu said the combination also showed a 4.9-month overall survival improvement versus standard chemotherapy.
SANOVO evaluated the same oral combination in the first-line setting among biomarker-selected patients. In the MET IHC 3+ population, Wu said median progression-free survival was 24.5 months, compared with 11.3 months for chemotherapy. He reported overall survival of 44.5 months for the combination and said peripheral edema was a notable adverse event, though grade 3 events were low.
Wu said rebiopsy after first-line treatment failure is important for identifying resistance mechanisms. He estimated that approximately 60% of patients in China and about 50% globally currently undergo rebiopsy.
AstraZeneca also presented DeLLphi-305 data in small-cell lung cancer. Leora Horn, senior vice president of late development oncology, said maintenance treatment with Imfinzi plus Imdelltra, following induction platinum-based chemotherapy and Imfinzi, generated median overall survival of 21.1 months compared with 12.7 months for Imfinzi alone. The overall survival hazard ratio was 0.42.
Progression-free survival was 7.4 months with the combination versus 1.9 months with Imfinzi monotherapy, Horn said. She characterized cytokine release syndrome and ICANS events as consistent with the known profile of tarlatamab and said treatment discontinuations related to adverse events were limited.
Gastric cancer ADC data
Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, presented results from CLARITY-Gastric01 evaluating Sone-Ve, a Claudin 18.2-directed ADC, in advanced or metastatic gastroesophageal cancer.
In the third-line-plus population, Sone-Ve reduced the risk of death by 53% versus investigator’s choice of therapy, corresponding to an overall survival hazard ratio of 0.47. One-year survival was 38.1% for Sone-Ve versus 18.1% for the control arm, Galbraith said.
In the second-line-plus population, the overall survival hazard ratio was 0.58, with median overall survival of 10.6 months versus 6.4 months. Galbraith said the treatment benefit was generally consistent across Claudin 18.2 expression thresholds above 25% and above 75%, as well as among patients with peritoneal metastases.
The blinded independent central review progression-free survival endpoint in second-line-plus patients did not reach statistical significance, although investigator-assessed progression-free survival showed a hazard ratio of 0.59, according to Galbraith. She said the company intends to seek a broad label covering second- and third-line settings.
Pipeline and commercial outlook
Chief Executive Officer Pascal Soriot said the company’s oncology pipeline includes ADCs, T-cell engagers, cell therapy and immunotherapy combinations. He said AstraZeneca is pursuing collaborations, including its arrangement with Summit Therapeutics, to pair ADC assets with PD-1/VEGF-directed therapies where appropriate.
Fredrickson said Sone-Ve represents a potential blockbuster opportunity and reiterated AstraZeneca’s previously cited $3 billion to $5 billion opportunity range for the medicine. He also said the company sees an opportunity to expand use of Imfinzi in bladder and small-cell lung cancer and to reinforce Tagrisso’s role as a treatment backbone across lines of EGFR-mutant lung cancer therapy.
Soriot said the company expects additional clinical readouts in 2027, including the AVANZAR study in the first quarter. He cautioned that not every pipeline program will succeed, but said AstraZeneca’s portfolio should be assessed collectively rather than through individual clinical events.
About Astrazeneca (NYSE:AZN)
AstraZeneca plc is a global, science-led biopharmaceutical company headquartered in Cambridge, United Kingdom. The company discovers, develops and commercializes prescription medicines, with a focus on oncology, biopharmaceuticals and rare diseases. Its research and commercial operations serve patients and healthcare systems across more than 100 countries.
AstraZeneca’s portfolio includes medicines for cancer, respiratory and immune-mediated conditions, cardiovascular, renal and metabolic diseases, and rare disorders.
