AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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.

GSK's Blenrep receives Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma treatment based on DREAMM-7 trial results, showing significant PFS improvements over standard care.

NURE-Combo trial evaluated nivolumab + nab-paclitaxel as neoadjuvant therapy for MIBC, followed by RC and adjuvant nivolumab. 31 patients enrolled; 32.3% achieved ypT0N0 response, 70.9% ypT≤1N0-x. 12-month EFS was 89.8%. First results suggest potential for immune-chemotherapy in MIBC.

MAIA Biotechnology Inc. reports encouraging interim results from phase 2 THIO-101 trial for advanced NSCLC, showing survival benefits with 16 patients exceeding 12 months follow-up. THIO targets telomeres to induce DNA damage and cancer cell death, with plans to explore its use in other cancers like HCC, SCLC, and malignant gliomas.

FDA approval of Imdelltra (tarlatamab-dlle) in 2024 for extensive-stage small cell lung cancer (ES-SCLC) provided hope for Sabrina Potts, who experienced significant improvement after treatment. Imdelltra, a bispecific T-cell engager, forces interaction between tumor and immune cells, leading to tumor attack. Despite side effects like cytokine release syndrome and neurologic toxicity, the therapy showed a 40% objective response rate with a median duration of response of 9.7 months. Challenges in SCLC treatment include late-stage diagnosis and frequent relapse, but recent advancements like Imdelltra and Imfinzi offer new options, though a cure remains elusive.

TORL BioTherapeutics appoints Dr. Howard A. Burris III to its Board, leveraging his expertise in cancer therapy development to advance the company's ADC programs and clinical trials.

FDA's July guidance on using real-world evidence (RWE) emphasizes data provenance, patient migration documentation, and avoiding data source bias. It does not cover devices or specific study designs, and minimal changes were made from the draft. Janssen and ASCO sought clarifications on data submission and RWE vs. electronic data capture. The FDA encourages pre-submission queries and has capacity for RWD/RWE expertise. The EMA's DARWIN project supports RWE use, aiming to improve clinical trial efficiency and reduce patient burden.