FDA Grants Priority Review to Sunvozertinib for NSCLC with EGFR Exon 20 Insertions
• The FDA granted priority review to sunvozertinib for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
• The application is for patients whose disease progressed after platinum-based chemotherapy, offering a potential new oral treatment option.
• The decision is based on the WU-KONG1 Part B study, which showed statistically significant clinical benefits in relapsed/refractory NSCLC.
• Sunvozertinib has already received accelerated approval in China for the same indication, marking it as a promising treatment worldwide.
Phase 2b Trial of Glecirasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer
A phase 2b trial investigates the efficacy of Glecirasib in treating KRAS G12C-mutated non-small-cell lung cancer, involving multiple institutions across China and the USA.
Zhaoke Ophthalmology's TAB014 Meets Primary Endpoint in Phase III wAMD Trial
• Zhaoke Ophthalmology's TAB014 met its primary endpoint in a Phase III trial for wet age-related macular degeneration (wAMD).
• The randomized, double-blind, non-inferiority study compared TAB014 to Lucentis in approximately 488 patients across 57 centers.
• TAB014, a recombinant humanized anti-VEGF monoclonal antibody, aims to inhibit angiogenesis by binding to VEGF.
• Zhaoke Ophthalmology has full control over TAB014's clinical development and commercialization in China, Hong Kong, and Macau.
Flonoltinib and Selinexor Combinations Show Promise in Myelofibrosis Treatment
• Flonoltinib demonstrated significant spleen and symptom response in myelofibrosis patients, suggesting it may be a new treatment option.
• A phase 2 trial showed selinexor combined with ruxolitinib led to spleen length reduction and symptom alleviation in myelofibrosis patients previously treated with ruxolitinib.
• Navitoclax combined with ruxolitinib showed durable responses and potential disease modification in relapsed/refractory myelofibrosis, improving spleen volume and symptoms.
• These studies highlight potential new strategies for myelofibrosis treatment, addressing unmet needs in patients with limited options.
Tislelizumab Plus Chemotherapy Shows Promise in Esophageal Cancer Treatment
• A Phase 2 study reveals that perioperative tislelizumab combined with neoadjuvant chemotherapy yields a 44% pathological complete response (pCR) rate in resectable ESCC.
• The regimen demonstrated a manageable safety profile, with most patients achieving R0 resection, indicating no residual microscopic disease after surgery.
• After neoadjuvant therapy, dynamic monitoring of circulating lymphocyte subsets may predict efficacy, with specific lymphocyte groups increasing significantly in pCR patients.
• The 1-year disease-free survival rate was 75.3%, suggesting a potential benefit in preventing cancer recurrence following treatment with tislelizumab and chemotherapy.
Pembrolizumab Plus Chemoradiotherapy Improves PFS in East Asian Cervical Cancer Patients
• In East Asian patients with high-risk, locally advanced cervical cancer, pembrolizumab plus concurrent chemoradiotherapy (CCRT) significantly improved progression-free survival (PFS).
• At 24 months, the PFS rate in the pembrolizumab plus CCRT arm was 77.6% compared to 59.8% in the placebo plus CCRT arm, demonstrating a substantial difference.
• The safety profile of pembrolizumab plus CCRT in the East Asian subgroup was manageable and consistent with the overall study population, supporting its potential use.
• These findings suggest pembrolizumab plus CCRT could be a new treatment option for this patient population, particularly relevant given the high incidence of cervical cancer in East Asia.
GnRH-a Plus Letrozole or LNG-IUD Compared to Progesterone for Atypical Endometrial Hyperplasia
• A clinical trial is underway comparing GnRH-a plus letrozole or LNG-IUD to traditional progesterone treatment for atypical endometrial hyperplasia (AEH).
• The study aims to assess the complete response rates of the combination therapies versus progesterone after 24 weeks of treatment.
• Secondary endpoints include pregnancy rates, recurrence rates, and safety profiles, offering a comprehensive evaluation of treatment efficacy.
• The trial incorporates rigorous data management and monitoring to ensure data quality and patient safety throughout the study.
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