Articles related to CLINICAL TRIALS

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.

Data from a large phase III trial (Myeloma XI) were examined to determine the relationship between MRD status, PFS, and OS in post-ASCT patients randomly assigned to lenalidomide maintenance or no maintenance at 3 months after ASCT. At ASCT + 3 and ASCT + 9, MRD-negative status was associated with improved PFS and OS. Sustained MRD negativity from ASCT + 3 to ASCT + 9 or the conversion to MRD negativity by ASCT + 9 was associated with the longest PFS/OS.

In an editorial accompanying the final results of the TOURMALINE-MM1 study, Drs. D’Souza and Lonial question whether overall survival (OS) is “still the gold standard for demonstrating the value of a novel agent in phase III trials early in the disease course given the current treatment landscape.”

According to the results of a study published in Annals of Hematology, two novel analytical approaches for detecting malignant plasma cell clones appear to accurately indicate the course of multiple myeloma (MM) and may be valuable for monitoring patients with serologically nontrackable disease.

The BILCAP study established capecitabine as the adjuvant standard of care for patients after curatively resected biliary tract cancer (BTC). This publication presents the long-term data of that study. In the intention-to-treat analysis, the median OS was 49.6 months in the capecitabine group compared with 36.1 months in the observation group.