Articles related to CHECKPOINT INHIBITORS

“For patients with T1cN1-2 or T2-4N0 (stage II or III), early-stage TNBC, the Panel recommends use of pembrolizumab (200 mg once every 3 weeks or 400 mg once every 6 weeks) in combination with neoadjuvant chemotherapy, followed by adjuvant pembrolizumab after surgery.”

An FDA expert panel voted 16-0, with one abstention, recommending that future FDA approvals of PI3K inhibitors be supported by randomized data. The four currently-approved PI3K inhibitors for treating hematologic malignancies received FDA approval based on single-arm data. Although these drugs have offered durable ORR and improvements in PFS, randomized data presented at the hearing showed they are associated with higher rates of serious adverse events, including fatality.

The recent 2022 ASCO GU Cancers Symposium provided important new data for the management of advanced prostate cancer. Presentations covered in this review of symposia highlights include androgen receptor (AR) inhibitors in patients with metastatic hormone-sensitive prostate cancer, combinations of PARP inhibitors with abiraterone acetate in metastatic castration-resistant prostate cancer, 177Lu-PSMA-617 in metastatic CRPC, some novel therapies, and even a look at an artificial intelligence pathology predictive biomarker.

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.