ESMO 2026: The biggest announcements from European biopharma

Immatics presented updates for two investigational treatments targeting PRAME, a cancer-associated protein that helps T cells identify tumors when targeted by treatment. IMA402 in particular showed an impressive 91% one-year survival rate in a subgroup of patients with advanced melanoma and high PRAME expression. We covered those announcements in more detail here.

BioNTech’s ESMO program centered on pumitamig, the investigational PD-L1×VEGF-A bispecific it is developing with Bristol Myers Squibb. The antibody combines checkpoint blockade with inhibition of a pathway involved in blood vessel growth.

• Pumitamig: The global Phase 2 ROSETTA Lung-107 trial tested pumitamig with the chemotherapy docetaxel after patients’ metastatic non-small cell lung cancer progressed on first-line immunotherapy and chemotherapy. Among 30 efficacy-evaluable patients, the confirmed response rate was 36.7%. Median progression-free survival, measured across 50 treated patients, was 6.9 months. Grade 3 or higher adverse events attributed to pumitamig occurred in 18%, and 8% discontinued because of pumitamig-related adverse events. The findings extend the candidate’s evidence into a difficult second-line setting. However, the study had no control arm and median follow-up was only 12.2 weeks, limiting comparisons with docetaxel alone.
• Pumitamig combination: BioNTech also presented a global Phase 2 study pairing pumitamig with elfetabart drozuntecan, a B7-H3-targeting antibody-drug conjugate developed with DualityBio. Among 139 evaluable patients, the response rate, including unconfirmed responses, was 48.9%, rising to 80.6% in 31 patients with platinum-resistant ovarian cancer. Grade 3 or higher treatment-related adverse events occurred in 38.7% of patients. The findings remain preliminary, with median follow-up of 6.3 months and no control group.
• Trastuzumab pamirtecan: BioNTech also reported a less encouraging result for trastuzumab pamirtecan, the investigational HER2-targeting ADC it is developing with DualityBio. The 541-patient Phase 3 DYNASTY-Breast02 trial met its primary endpoint in HR+/HER2-low metastatic breast cancer, but the companies described the progression-free survival improvement over chemotherapy as “modest” and said the potential patient benefit appeared limited. They also reported more interstitial lung disease than in previous trials, including severe and fatal cases. Numerical efficacy results were not disclosed, overall survival remained immature, and the partners will determine next steps. The announcement was released during ESMO, without being identified as a congress presentation.

AstraZeneca presented results for its investigational gastric cancer ADC sonesitatug vedotin and several lung and bladder cancer combinations:

• Sonesitatug vedotin (CLDN18.2-targeting ADC): In the Phase 3 CLARITY-Gastric01 trial, median overall survival reached 10.6 months versus 6.4 months with investigator’s choice of treatment in previously treated advanced gastroesophageal cancers. In the third-line and later population, where survival was a primary endpoint, the figures were 10 months versus five months. However, the independently assessed progression-free survival co-primary endpoint missed statistical significance: 4.2 versus 3.8 months, with a reported p-value of 0.053.
• Tagrisso plus savolitinib (EGFR/MET inhibitor combination): In Phase 3 SAFFRON, the combination improved outcomes in EGFR-mutated lung cancer with high MET overexpression or amplification after progression on Tagrisso. Median overall survival was 17.8 versus 12.9 months with platinum-based chemotherapy, while median progression-free survival was 7.6 versus 5.4 months. AstraZeneca said it had submitted the combination to the FDA.
• The same combination in first-line treatment: The China-based Phase 3 SANOVO trial tested Tagrisso plus savolitinib in untreated EGFR-mutated, MET-overexpressing lung cancer. Median progression-free survival reached 24.9 versus 13.8 months with Tagrisso alone.

Roche presented Phase 3 results for its investigational KRAS G12C inhibitor divarasib and its MediLink-partnered antibody-drug conjugate tambotatug pelitecan:

• Divarasib (KRAS G12C inhibitor): In Krascendo 1, median overall survival reached 17.7 months versus 12 months with sotorasib or adagrasib in previously treated KRAS G12C-mutated non-small cell lung cancer. Median progression-free survival was 9.8 versus 5.7 months. Treatment-related adverse events caused discontinuation in 4.8% versus 11.7% of patients, respectively. The head-to-head result gives Roche a stronger case for divarasib to replace first-generation KRAS inhibitors.
• Tambotatug pelitecan (B7-H3-targeting ADC): In the China-based TAISHAN-301 trial in heavily pretreated nasopharyngeal cancer, response rates were 50.8% versus 25.8% with physician’s choice of treatment. Median response duration was 7.9 versus 6.4 months. The findings met a response co-primary endpoint but did not establish a survival advantage.

Genmab presented updated Phase 2 colorectal cancer findings for petosemtamab, an investigational bispecific antibody targeting EGFR and LGR5. separately announced Phase 3 RAINFOL-02 results for Rina-S, its investigational folate receptor alpha-targeting ADC, in platinum-resistant ovarian cancer. We cover those announcements in more detail here.

CatalYm presented Phase 2a results for visugromab, an investigational antibody targeting GDF-15, a tumor-derived cytokine associated with immune suppression.

The exploratory GDFATHER-NEO trial tested visugromab plus nivolumab before surgery for muscle-invasive bladder cancer. Locally assessed pathological complete responses occurred in five of 15 evaluable patients (33%), compared with one of 13 (8%) receiving nivolumab plus placebo. Radiographic response rates were 60% versus 15%. The findings support further investigation of whether GDF-15 blockade can increase checkpoint inhibitor activity.

Nanobiotix reported final melanoma cohort data from Phase 1 Study 1100 evaluating its J&J-partnered NBTXR3 (also called JNJ-1900) with radiotherapy followed by nivolumab or pembrolizumab.

The investigational treatment is injected into a tumor and activated by radiotherapy. Among 24 heavily pretreated patients whose melanoma had resisted anti-PD-1 therapy, 10 responded (41.7%), including four complete responses. Median progression-free survival was 6.9 months, and median overall survival was 17.8 months.

Responses occurred in both injected and non-injected lesions, supporting further investigation of systemic immune effects. The findings update earlier data, but the small, uncontrolled study cannot establish a survival benefit or isolate the contribution of each treatment component.

Brenus Pharma presented Phase 1a results for STC-1010, its investigational off-the-shelf immunotherapy designed to stimulate immune recognition of tumors.

Nine patients with initially unresectable, microsatellite-stable metastatic colorectal cancer were treated in BreAK CRC-001. Among seven evaluable patients, four responded (57%) and three became eligible for surgery. Two subsequently had no evidence of disease. The study also reported increased tumor infiltration by cytotoxic T cells.

STC-1010 was administered in a regimen that included chemotherapy. With seven evaluable patients and no control group, the findings remain an early signal and cannot establish the immunotherapy’s added benefit.

TILT Biotherapeutics presented preliminary Phase 1b PROTA results for its investigational oncolytic immunotherapy TILT-123 combined with pembrolizumab and pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.

Among nine evaluable patients out of 14 treated, four responded (44%), with two subsequently achieving complete responses. One response remained ongoing at 12 months, while another patient progressed 21 months after starting treatment. No dose-limiting toxicities or unexpected safety signals were reported.

The findings support further investigation, but the small, uncontrolled study cannot establish how much TILT-123 adds to pembrolizumab and chemotherapy.