Articles related to CLINICAL TRIALS

Compared to chemotherapy alone, adebrelimab plus chemotherapy nearly doubled 2-year OS and more than tripled 1-year PFS in patients with extensive-stage SCLC, according to results presented earlier this month at the AACR Annual Meeting 2022. The phase 3 CAPSTONE-1 study evaluated adebrelimab in combination with carboplatin plus etoposide, as first-line treatment for ES-SCLC.

Predictive biomarkers are needed to identify patients with oropharyngeal squamous cell carcinoma (OPSCC) that could enjoy treatment de-escalation, with the attendant reduction in incidence of acute and late toxicities. In an observational study of consecutive patients with patients with oropharyngeal squamous cell carcinoma, pretreatment absolute lymphocyte count was predictive for 5-year overall survival. It also predicted benefit from the use of concurrent cisplatin chemotherapy.

A 12-year odyssey of a cancer drug that works in a subcellular organelle: From discovery of a unique and promising tumor target – featured on the cover of the Journal of Clinical Investigation – through startup company, grant-writing, DoD funding, Wall Street disinterest, perseverance, and finally, approval to initiate clinical trials.

According to the final results from the phase 3 PALLAS trial, palbociclib offers no benefit over endocrine therapy alone in women with early HR+ HER2- breast cancer. The primary endpoint — 4-year invasive DFS — was nearly equivalent in the test and control arms of the study. None of the secondary endpoints showed a significant difference either. There was a high rate of palbociclib discontinuation (42%), mostly due to grade 3 or 4 neutropenia. But even in those who completed the two-year planned course showed no benefit over endocrine therapy alone. The results were not just disappointing, but surprising given that CDK 4/6 inhibitors plus endocrine therapy is the standard of care for advanced breast cancer.

This single-arm study of 40 patients with advanced neuroendocrine tumors (NETs) sought to evaluate the potential benefit of a VEGF inhibitor plus a PD-L1 inhibitor. The primary endpoint was objective radiographic response. Responses were seen in 15% to 20% of patients.

The phase 3 KEYNOTE-048 trial compares pembrolizumab with or without concurrent chemotherapy to cetuximab-chemotherapy in patients with recurrent or metastatic head and neck SCC. Patients were evaluated in subgroups based on PD-L1 expression. In median survival, pembrolizumab + chemotherapy outperformed cetuximab + chemotherapy in all patient subgroups regardless of PD-L1 expression. In the PD-L1 CPS 1-19 subgroup, pembrolizumab alone slightly outperformed cetuximab + chemotherapy. In the PD-L1 CPS < 1 subgroup median survival was significantly lower with pembrolizumab alone.