AMERICAN SOCIETY OF CLINICAL ONCOLOGY

NMPA grants Breakthrough Therapy Designation to Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone for relapsed or refractory multiple myeloma, based on phase III DREAMM-7 trial results showing significant PFS improvements. A positive OS trend was observed but not statistically significant at interim analysis.

Regeneron's melanoma combo therapy, fianlimab plus Libtayo, shows 25% complete response and 57% objective response rates after 23 months in a Phase I trial, with ongoing Phase III studies.

Kisqali (ribociclib) + endocrine therapy (ET) reduces recurrence risk by 28.5% beyond 3 years in HR+/HER2- early breast cancer, with consistent benefits across subgroups, including node-negative disease. Safety remains consistent with low-grade adverse events. Results to be presented at ESMO; FDA action expected in Q3.

Adjuvant pembrolizumab (Keytruda) continues to show improved disease-free survival (DFS) vs observation in high-risk muscle-invasive urothelial carcinoma patients after 45 months of follow-up, according to the phase 3 A031501 AMBASSADOR trial. Median DFS was 29.6 months in the pembrolizumab arm vs 14.2 months in the observation arm, with DFS benefits observed regardless of PD-L1 expression and lymph node status.

23ME-00610, an anti-CD200R1 antibody, shows preliminary clinical benefit in clear-cell renal-cell carcinoma with one confirmed partial response. Higher CD200 tumor expression and human genetics correlate with increased clinical benefit, suggesting potential as patient selection biomarkers. Greater response in 'cold' tumors indicates opportunity for patients unresponsive to PD-1/PD-L1 inhibitors.

GSK's Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) received Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma. The designation is based on the DREAMM-7 trial's interim results showing significant improvements in progression-free survival (PFS) compared to daratumumab plus BorDex. A positive overall survival (OS) trend was observed but not statistically significant at the interim analysis. The trial also showed deeper and more durable responses across secondary endpoints. Multiple myeloma is a growing concern in China with approximately 30,000 new cases annually.

CMOs Davey B. Daniel and Stephen “Fred” Divers discuss the challenges of keeping up with practice-changing data and integrating it into oncology care, emphasizing the need for strategic data management and interoperability to improve patient outcomes.

A randomized clinical trial involving 757 participants found that the complete multicomponent Symptom Care at Home intervention, including automated self-management coaching and clinician follow-up for moderate and severe symptoms, achieved the greatest reduction in symptom burden compared to individual components alone. This suggests that multicomponent digital approaches to cancer symptom management offer optimal symptom burden reduction during chemotherapy treatment.

AstraZeneca Korea launched Truqap, the first AKT inhibitor for HR+/HER2- breast cancer, targeting PIK3CA, AKT1, or PTEN mutations. Truqap, approved in April, offers new hope for patients progressing after endocrine therapy. The CAPItello-291 study showed Truqap plus fulvestrant doubled median progression-free survival to 7.3 months. Despite financial concerns over NGS costs, global guidelines recommend mutation testing for effective treatment.