AMERICAN SOCIETY OF CLINICAL ONCOLOGY

FDA's ODAC reviewed AEGEAN trial data on durvalumab for stage IIa to IIIb non–small cell lung cancer, flagging study design issues. FDA now requires 2-arm trial designs to address neoadjuvant vs adjuvant durvalumab roles, potentially impacting patient safety, drug approval timelines, and costs.

Nivolumab (Opdivo) plus standard chemotherapy (AVD) showed longer progression-free survival (PFS) and better side-effect profile compared to brentuximab vedotin (Adcetris) plus AVD in advanced-stage Hodgkin's lymphoma patients, according to the SWOG S1826 trial.

A new immunotherapy treatment for advanced Hodgkin lymphoma raised survival rates to 92%, suggesting it could become the new standard therapy. The treatment, which combines chemotherapy with immunotherapy nivolumab, was found to reduce long-term side effects and improve outcomes for pediatric and older patients.

Junshi Biosciences announces toripalimab (ZYTORVI®/LOQTORZI®) approval for recurrent or metastatic nasopharyngeal carcinoma (NPC) in India and Hong Kong SAR. The drug is approved for first-line treatment in combination with cisplatin and gemcitabine, and as a single agent for patients with disease progression after platinum-containing chemotherapy. Toripalimab has been approved in over 30 countries and regions.

Dizal received its fourth Breakthrough Therapy Designation (BTD) for sunvozertinib from China's CDE for first-line treatment of EGFR exon20ins NSCLC, following US FDA's BTD in April. Sunvozertinib showed 78.6% cORR and 12.4 months mPFS in phase I/II studies, with ongoing phase III WU-KONG28 study comparing it to platinum doublet chemotherapies. Sunvozertinib is the first oral drug approved for EGFR exon20ins NSCLC in China, with ongoing regulatory submissions globally.

Clarity Pharmaceuticals to commence pivotal Phase III AMPLIFY trial of ⁶⁴Cu-SAR-bisPSMA diagnostic in prostate cancer patients with biochemical recurrence, following positive U.S. FDA feedback. The trial aims to detect prostate cancer recurrence using ⁶⁴Cu-SAR-bisPSMA PET/CT, with patient recruitment expected in early 2025.

Mayo Clinic event discussed cannabis use in cancer care and drug costs. Cannabis strains and delivery systems were detailed, with limited data on efficacy. Drug costs in cancer care were highlighted, emphasizing the need for policy changes to manage skyrocketing prices.

Dizal receives fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins, reflecting its transformative potential and Dizal's commitment to developing new treatments for unmet medical needs globally.

Dizal receives fourth Breakthrough Therapy Designation for sunvozertinib in EGFR exon20ins NSCLC, following U.S. FDA approval in April. Sunvozertinib, an irreversible EGFR inhibitor, showed a 78.6% confirmed objective response rate and 12.4 months median progression-free survival in treatment-naïve patients. The drug is also being evaluated in a phase III multinational study.

Thyme Care, founded in 2020, has expanded its cancer care services to over 3000 patients by 2023, achieving a $594 cost reduction per patient per month. With a $95 million funding round in 2024, the company aims to further reduce pharmacy waste and administrative burdens through data analytics, improve referral processes among oncology and primary care, and integrate deeply into partner practices to find efficiencies. Thyme Care's model, which assumes two-sided risk, focuses on enhancing patient experience, quality, and waste reduction, attracting investors like Concord Health Partners. The company plans to tackle drug spend collaboratively with oncologists and improve value-based care arrangements, with a focus on early palliative care and supportive services.