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.

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 a single-center study of 240 patients with lymphoid malignancies — 181 with CLL, 21 with WM, and 38 with other non-Hodgkin lymphomas (NHLs) – patients with CLL were significantly more likely to have an antibody response to the Moderna vaccine compared to the Pfizer-BioNTech vaccine. This superior response was demonstrated in both treatment naïve and treated CLL populations in the study.

The US Food and Drug Administration (FDA) has said “no” to Akebia Therapeutics’ drug application for vadadustat, a therapy to treat anemia due to chronic kidney disease. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. The FDA cited safety concerns as the main reason for it rejecting the application.