Blenrep combinations approved in EU for treatment of R/R multiple myeloma

CLINICAL AND REGULATORY 

Blenrep combinations approved in EU for treatment of relapsed/refractory multiple myeloma 

GSK announced the approval of Blenrep in the European Union for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. The approval is based on superior efficacy results demonstrated by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 Phase 3 trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful PFS for Blenrep combinations versus triplet standard of care combinations in both trials and OS versus a daratumumab-based triplet in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents. Blenrep combinations are also approved in relapsed or refractory multiple myeloma in the UK and Japan as well as other markets, including Canada and Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the US and China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application). 

Enhertu plus pertuzumab granted Breakthrough designation as first-line for HER2+ breast cancer

Enhertu in combination with pertuzumab has been granted Breakthrough Therapy Designation in the US for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. Enhertu is a specifically engineered HER2 directed DXd ADC discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi and AstraZeneca. The designation is based on data from the DESTINY-Breast09 Phase 3 trial presented during a special late-breaking oral session at the 2025 ASCO Annual Meeting. 

Akeso's first bispecific ADC targeting Trop2 and Nectin4 enters clinical trials 

Akeso announced the successful enrollment of the first patient in its Phase 1a clinical trial for AK146D1, a bispecific ADC targeting Trop2 and Nectin4. AK146D1 is Akeso's first bispecific ADC to enter clinical trials. AK146D1 has recently received approval from the FDA, Australia's TGA, and China's NMPA to begin clinical trials. Currently, Akeso's globally first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both been approved in China. The company has also rolled out a series of leading therapeutic strategies worldwide. Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, positioning it with a strong global leadership advantage in the IO+ADC space. 

Alphamab’s anti-HER2 biparatopic ADC will enter Phase 2 study for platinum-resistant ovarian cancer

Alphamab Oncology announced that anti-HER2 biparatopic ADC JSKN003 has received approval from FDA to initiate a Phase 2 study in the US for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels. JSKN003 is an anti-HER2 biparatopic ADC developed inhouse which can bind HER2 on the surface of tumor cells and release TOP1 inhibitors through cellular endocytosis, thereby exerting anti-tumor effects. In China, three Phase 3 studies of JSKN003 for the treatment of HER2-low expressing breast cancer, platinum-resistant ovarian cancer, and HER2-positive BC are currently undergoing.

DEALS AND FINANCING

Oncomatryx awarded €12.5 million EIC Accelerator funding to advance groundbreaking ADCs 

Oncomatryx Biopharma, a biotechnology company pioneering next-generation ADCs for oncology, has been awarded funding from the European Innovation Council (EIC) Accelerator under the EU’s Horizon Europe 2021-2027 Research and Innovation Program. Oncomatryx will receive €2.5 million in grant funding, along with a €10 million equity investment in its upcoming financing round. Oncomatryx’s ADC platform integrates proprietary novel payloads and advanced conjugation formats. Oncomatryx is currently advancing its lead ADC candidate, OMTX705, in clinical trials targeting Fibroblast Activation Protein in aggressive tumors with high unmet medical need. Encouraging clinical data has been presented at ASCO 2025 meeting. Ninety-five patients were treated in the dose escalation and 3 backfilling cohorts of metastatic immune-cold solid tumors. An outstanding safety profile, with no dose limiting toxicity was shown, as well as long responses in patients expressing FAP. Randomized clinical trials are ongoing in immune-cold metastatic pancreatic, MSS colorectal and non-small cell lung cancer.