Imfinzi Approved for Limited-Stage Small Cell Lung Cancer, Redefining Treatment
• The FDA has approved AstraZeneca's Imfinzi (durvalumab) for treating adults with limited-stage small cell lung cancer (LS-SCLC) after platinum-based chemotherapy and radiation therapy.
• The approval was based on the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death compared to placebo, marking a significant breakthrough.
• Median overall survival improved to 55.9 months with Imfinzi versus 33.4 months with placebo, establishing a new benchmark for LS-SCLC treatment.
• Imfinzi is now the only immunotherapy approved for both limited and extensive-stage small cell lung cancer, underscoring its potential to improve survival rates.
Ensartinib Approved by FDA for First-Line ALK-Positive Non-Small Cell Lung Cancer
• The FDA has approved ensartinib (Ensacove) for first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
• Ensartinib demonstrated statistically significant improvement in progression-free survival compared to crizotinib in the eXALT3 trial.
• Common adverse reactions to ensartinib include rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.
• The recommended dose of ensartinib is 225 mg orally once daily until disease progression or unacceptable toxicity.
Recent Clinical Trial Updates and FDA Actions in Oncology: A Review
• The VERONA and SELECT-MDS-1 trials are evaluating novel combinations in myelodysplastic syndromes (MDS) that could potentially shift the treatment paradigm.
• Enhertu (fam-trastuzumab deruxtecan-nxki) has received priority review from the FDA for HER2-low/ultra-low breast cancer, showing promise as a targeted treatment option.
• The LEAP-012 trial demonstrated that lenvatinib plus pembrolizumab with TACE significantly improved progression-free survival in intermediate-stage hepatocellular carcinoma (HCC).
• Keynote-522 trial results confirm that neoadjuvant pembrolizumab combined with chemotherapy, followed by adjuvant pembrolizumab, improves overall survival in early-stage triple-negative breast cancer.
Nivolumab Plus Radiotherapy Improves Outcomes in High-Risk Prostate Cancer
• A phase 2 trial showed that adding nivolumab to standard radiotherapy significantly improved freedom from biochemical recurrence (FFBR) in patients with Gleason grade group 5 prostate cancer.
• At 2 years, the FFBR rate was 90.3% in the nivolumab plus radiotherapy arm, compared to a historical control rate of 75% (p = 0.025).
• Biomarker analysis revealed that the Ricketts Gene Signature correlated with early pathological and radiographic responses, potentially aiding in patient selection.
• The addition of nivolumab to trimodality therapy was associated with improvements in FFBR compared to contemporary controls, despite a higher baseline rate of metastatic disease.
Veracyte's Decipher Test Accurately Predicts Aggressive Prostate Cancer in Black Men
• Veracyte's Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer in African American men, according to the VANDAAM trial.
• The Decipher test, initially developed using primarily White American males, shows comparable accuracy in predicting metastasis in both African American and non-African American men.
• High Decipher scores correlate with an eight-fold increased risk of biochemical recurrence within two years, regardless of race.
• Veracyte aims to expand access to Decipher testing to address equity gaps and improve treatment decisions for all prostate cancer patients.
Nivolumab Plus Standard Therapy Improves Outcomes in High-Risk Prostate Cancer
• A Phase 2 trial evaluated nivolumab with androgen deprivation therapy (ADT) and radiation in Gleason Grade Group 5 prostate cancer patients.
• The addition of nivolumab significantly improved 2-year freedom from biochemical recurrence compared to historical controls (90.3% vs 75%).
• The nivolumab cohort showed a significant improvement in 3-year freedom from biochemical recurrence compared to controls (90.4% versus 68.8%, p=0.027).
• Multivariable analysis showed nivolumab was significantly associated with improved biochemical recurrence rates (HR: 0.13, p=0.008).
Plinabulin Combination Shows Tolerability in Recurrent Small Cell Lung Cancer Trial
• A Phase I/II trial evaluated plinabulin with nivolumab and ipilimumab in recurrent small cell lung cancer (SCLC) patients, focusing on safety and efficacy.
• The combination was found to be tolerable, with a recommended Phase 2 dose of plinabulin at 30 mg/m², though common adverse events included vomiting and nausea.
• The trial did not meet its primary endpoint of a median progression-free survival of 3.5 months, but some patients exhibited durable responses to the treatment.
• The rate of grade 3 or higher immune-related adverse events was lower than anticipated, suggesting a potentially manageable safety profile for the combination therapy.
© Copyright 2025. All Rights Reserved by MedPath