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#Pembrolizumab

Sellas' Ovarian Cancer Candidate Shows Clinical Benefit In Pretreated Patients

SELLAS Life Sciences Group Inc SLS announced topline data from its Phase 1/2 trial of galinpepimut-S (GPS) in WT1(+) relapsed or refractory platinum-resistant advanced metastatic ovarian cancer. The trial evaluated SELLAS' peptide immunotherapeutic combined with Merck & Co Inc's MRK Keytruda (pembrolizumab). Data from 15 patients enrolled in the study...
CANCER
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Nature.com

Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort

Immune checkpoint inhibitors (ICIs) show limited clinical activity in patients with advanced soft-tissue sarcomas (STSs). Retrospective analysis suggests that intratumoral tertiary lymphoid structures (TLSs) are associated with improved outcome in these patients. PEMBROSARC is a multicohort phase 2 study of pembrolizumab combined with low-dose cyclophosphamide in patients with advanced STS (NCT02406781). The primary endpoint was the 6-month non-progression rate (NPR). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and safety. The 6-month NPR and ORRs for cohorts in this trial enrolling all comers were previously reported; here, we report the results of a cohort enrolling patients selected based on the presence of TLSs (n"‰="‰30). The 6-month NPR was 40% (95% confidence interval (CI), 22.7"“59.4), so the primary endpoint was met. The ORR was 30% (95% CI, 14.7"“49.4). In comparison, the 6-month NPR and ORR were 4.9% (95% CI, 0.6"“16.5) and 2.4% (95% CI, 0.1"“12.9), respectively, in the all-comer cohorts. The most frequent toxicities were grade 1 or 2 fatigue, nausea, dysthyroidism, diarrhea and anemia. Exploratory analyses revealed that the abundance of intratumoral plasma cells (PCs) was significantly associated with improved outcome. These results suggest that TLS presence in advanced STS is a potential predictive biomarker to improve patients' selection for pembrolizumab treatment.
CANCER
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