FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
The FDA has granted priority review to Merck’s supplemental Biologics License Application for the anti-PD–1 agent pembrolizumab as monotherapy for certain patients with high-risk, non-muscle invasive bladder cancer who are ineligible for or have elected not to undergo cystectomy.
Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that uses a patient’s own genetically modified T-cells to fight cancer.
Although chimeric antigen receptor (CAR) T-cell therapy has achieved remarkable long-lasting remissions in B-cell malignancies, in approximately 60% of the cases, the initial response wanes over time because of “immune exhaustion.” The use of a checkpoint inhibitor to boost immune response to CAR T-cell therapy is gaining traction as an attractive approach, according to 2 early studies presented at ASH 2018.
A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at the 2018 American Society of Hematology (ASH) annual meeting. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.
Combining an immune checkpoint inhibitor and a tyrosine kinase inhibitor (TKI) significantly improved progression-free survival (PFS) in treatment-naïve patients with advanced renal-cell carcinoma (RCC) compared with a TKI alone.
The combination of immunotherapy with nivolumab (Opdivo) and ipilimumab (Yervoy) may soon represent a new first-line treatment option in patients with early-stage metastatic colorectal cancer (CRC) associated with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors. Two studies presented at the ESMO 2018 Congress demonstrated the efficacy of this combination in this patient population.
Learning how to activate and harness the immune system—the body’s built-in defense against disease—has brought the field of oncology to the cusp of a cure for at least some, if not many, types of cancer, according to an international authority in immuno-oncology.
“This study is a fantastic advance for patients with brain metastases. It shows that combination immunotherapy can shrink brain metastases in a substantial proportion of patients,” said Michael A. Postow, MD.
“The overall survival findings are far superior to what we might anticipate with traditional therapies in this relapsed or refractory DLBCL population,” said Jeremy S. Abramson, MD, MMSc.
At ASCO 2018, 3 new studies that explore chemotherapy plus immunotherapy got high remarks from Sibylle Loibl, MD, PhD, including a regimen that may be a new standard of care.
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Results 1 - 10 of 14
Results 1 - 10 of 14