Spain Takes Leading EU Role in Trials of Next-Generation Cancer Therapies

Spain builds a central role in European oncology research

Spain hosts the largest number of clinical trials in the European Union, with a substantial share focused on cancer, according to EL ESPAÑOL-Invertia. Its hospitals are testing a new generation of treatments that includes antibody-drug conjugates, bispecific antibodies, CAR-T therapies and therapeutic vaccines. The programs reflect a wider shift from treating cancers primarily by tumor type toward selecting therapies according to each patient’s biological markers.

María Jesús Rubio, an oncologist at Reina Sofía University Hospital and a researcher at the Maimónides Biomedical Research Institute of Córdoba, said the change began with the first monoclonal antibodies early this century and is now accelerating. She is working with antibody-drug conjugates, which combine a monoclonal antibody with chemotherapy. The antibody directs the molecule toward cancer cells, while the chemotherapy component supplies the destructive effect, limiting exposure elsewhere in the body.

Multicenter trials target difficult tumors

One drug under investigation is trastuzumab pamirtecan, also known as BNT323, for endometrial cancer. The trial enrolls patients whose tumors overexpress HER2, a marker also found in breast cancer and in up to 30% of endometrial tumors. Rubio told EL ESPAÑOL-Invertia that the treatment produced a 47.9% response rate and a median response duration of up to 11 months among heavily pretreated patients.

The current standard treatment combines chemotherapy and immunotherapy. Rubio said BNT323 had produced responses after progression in patients who received first-line immunotherapy, a group for whom subsequent treatment can be more difficult. Reina Sofía is participating alongside eight other Spanish hospitals located in Madrid, Catalonia, the Basque Country and the Valencian Community.

Other experimental drugs are distributed across as many as 20 centers. Pumitamig, a bispecific antibody, is being studied through seven trials in Spain. The molecule targets both PD-L1, which tumors use to suppress the immune response, and VEGF-A, which supports the formation of blood vessels that feed cancer cells. Jorge Bartolomé, director of the Experimental Therapies Unit at Hospital Clínico San Carlos, said development is advanced in non-small-cell lung cancer, triple-negative breast cancer and other solid tumors. His center has four patients receiving the therapy, while recruitment remains open.

Therapeutic vaccines approach a regulatory milestone

Therapeutic cancer vaccines represent another part of the pipeline. Unlike preventive vaccines, these products are administered after surgical removal of a tumor to reduce the risk of recurrence. Moderna and MSD announced this month that an interim analysis of their melanoma vaccine met its objectives for time to recurrence and progression to metastasis. Earlier data indicated a reduction in that risk of at least 50%.

Six Spanish hospitals are participating in the phase 3 study, the final clinical stage before a medicine can be submitted for approval. Eva Muñoz, an oncologist at Vall d’Hebron involved in the trial, said confirmation of the earlier findings could create a new treatment standard and require sequencing of every tumor to identify the appropriate personalized product.

Diagnostics become part of the investment equation

The commercialization opportunity extends beyond drug developers. Personalized therapies require sequencing, biomarker testing, laboratory capacity and systems able to move clinical data rapidly between hospitals. Rubio said artificial intelligence could reduce analysis of tumor samples from 15 days to three minutes and make results available worldwide within seconds.

For pharmaceutical companies and clinical-research providers, Spain’s large trial base offers access to hospitals, investigators and eligible patients across several regions. The remaining challenge is whether precision diagnostics and complex treatments can be deployed beyond major research centers. Their market impact will depend not only on clinical efficacy and regulatory approval, but also on sequencing capacity and equal access to diagnosis.