Silas Inman

Novel combination approaches are being explored that hope to capitalize on the high rates of complete remissions seen with CAR T-cell therapies for patients with hematologic malignancies.

The CD19-directed CAR T-cell therapy JCAR017 demonstrated a 60% complete response rate in patients with relapsed or refractory CD19-positive non-Hodgkin lymphoma.

Treatment with the CD19-directed CAR T-cell therapy KTE-C19 showed a complete remission rate of 73% for patients with aggressive, chemorefractory primary mediastinal B-cell lymphoma and transformed follicular lymphoma.

The CAR T-cell therapy CTL019 demonstrated an 82% complete remission (CR) or CR with incomplete blood count recovery rate for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The preferred primary therapy for patients with multiple myeloma is induction therapy with a triplet regimen followed by autologous stem cell transplantation, consolidation, and maintenance.

The CHMP has recommended the approval of lenvatinib in combination with everolimus for patients with advanced renal cell carcinoma following one prior VEGF-targeted therapy.

After less than a week, the FDA has lifted a clinical hold placed on the phase II ROCKET study that is exploring the CAR T-cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

The FDA has placed a clinical hold on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Treatment with single-agent nivolumab improved overall survival and objective response rates compared with investigator's choice of therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

The FDA has approved the combination of lenvatinib and everolimus as a treatment for patients with advanced renal cell carcinoma (RCC) following prior anti–angiogeneic therapy

The FDA has granted a breakthrough therapy designation to nivolumab as a single-agent treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck following a platinum-based therapy.

Treatment with single-agent nivolumab reduced the risk of death by 30% and double 1-year overall survival rates compared investigator's choice of therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

Chimeric antigen receptor-modified T-cell therapies have demonstrated durable complete responses for patients with relapsed/refractory B-cell acute lymphoblastic leukemia; however, several questions remain regarding their optimal use and applicability outside of this disease.

Chimeric antigen receptor-modified T-cell therapies continue to demonstrate promising signs of efficacy for patients with hematologic malignancies, including those with acute lymphoblastic leukemia and non-Hodgkin lymphoma.

The second interim analysis of the phase III METEOR trial has revealed a statistically significant improvement in overall survival with cabozantinib (Cometriq) versus everolimus as a treatment for patients with advanced renal cell carcinoma following progression on one prior therapy.

Treatment with allogeneic anti–CD19 chimeric antigen receptor–modified T cell therapy induced complete remissions in 30% of patients with advanced progressive B-cell malignancies without causing graft-versus-host disease.

The FDA has granted a priority review designation to cabozantinib as a treatment for patients with advanced renal cell carcinoma following progression on one prior therapy.

Nivolumab has improved overall survival versus investigator's choice of therapy for patients with platinum-refractory squamous cell carcinoma of the head and neck in the phase III CheckMate-141 trial.

The FDA has granted a priority review designation to the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following one prior VEGF-targeted therapy.

Regulatory filings have been submitted in the United States and Europe for the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following a VEGF-targeted therapy.

A new drug application has been submitted for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy.

The FDA has granted a breakthrough therapy designation to the third-generation EGFR TKI BI-1482694 as a potential treatment for patients with EGFR T790M-positive non–small cell lung cancer.

Two CD19-targeted chimeric antigen receptor-modified T-cell therapies demonstrated complete response rates ranging from 90% to 100% in patients with high-risk acute lymphoblastic leukemia.

Updated findings from early stage clinical trials exploring chimeric antigen receptor-modified T-cell therapies continue to highlight the effectiveness of these approaches for patients with non-Hodgkin lymphoma.

The FDA has approved nivolumab as a treatment for patients with metastatic renal cell carcinoma following prior treatment with an anti-angiogenic therapy.

The FDA has granted a breakthrough therapy designation to avelumab as a potential treatment for patients with metastatic Merkel cell carcinoma following progression on at least one prior chemotherapy regimen.

The FDA has assigned a priority review designation to the PD-1 inhibitor nivolumab as a treatment for patients with advanced renal cell carcinoma following prior antiangiogenic therapy.

The FDA has granted an accelerated approval to osimertinib for patients with advanced EGFR T790M mutation positive non–small cell lung cancer following prior therapy on a prior EGFR TKI.

The combination of lenalidomide and rituximab demonstrated an objective response rate of 92% as initial therapy for patients with mantle cell lymphoma.

The FDA has granted a breakthrough therapy designation to pexidartinib as a potential therapy for patients with tenosynovial giant cell tumor for which surgical removal is contraindicate.