Caroline Seymour

The FDA has granted a fast track designation to TTI-101 for the treatment of patients with relapsed/refractory locally advanced, unresectable, or metastatic hepatocellular carcinoma.

The European Commission has approved axicabtagene ciloleucel for the treatment of adult patients with diffuse large B-cell lymphoma or high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

The FDA has granted an orphan drug designation to ET140203 for the treatment of patients with hepatoblastoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for cemiplimab monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after platinum-based chemotherapy.

Treatment with ibrutinib for at least 5 years showed favorable complete response rates and tolerability in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who were randomized to receive the BTK inhibitor in the phase 3 RESONATE-2 trial.

Fixed-duration treatment with ibrutinib and venetoclax led to deeper and prolonged undetectable minimal residual disease responses vs chlorambucil and obinutuzumab in the frontline treatment of elderly or unfit patients with chronic lymphocytic leukemia, translating to fewer relapses in the first year following treatment cessation.

The combination of avelumab and axitinib demonstrated promising response rates and progression-free survival and an expected safety profile in pretreated patients with advanced type B3 thymoma and thymic carcinoma, according to findings from an ongoing phase 2 study.

Bendamustine plus rituximab followed by autologous stem cell transplant and maintenance rituximab led to comparable outcomes defined by progression-free survival and objective response rate compared with R-CHOP/R-DHAP and ASCT as induction therapy in patients with mantle cell lymphoma.

Tivozanib demonstrated an improvement in overall survival compared with sorafenib in pretreated patients with advanced clear cell renal cell carcinoma, particularly in those who remained progression-free at 1 year and beyond.

Toni K. Choueiri, MD, provides perspective on key research in renal cell carcinoma, including the first demonstration of benefit with triplet therapy in metastatic clear cell disease, the expansion of HIF-2α inhibition into the first line, and success with VEGF/immune-oncology approaches in the non–clear cell population.

The addition of dostarlimab to chemotherapy led to an improvement in objective response rate vs pembrolizumab plus chemotherapy in patients with newly diagnosed metastatic nonsquamous non–small cell lung cancer.

The addition of SCO-101 to FOLFIRI chemotherapy was safe and tolerable but failed to elicit a greater than 30% reduction in tumor volume in patients with metastatic colorectal cancer, though study of the combination will continue.

Treatment with pacritinib led to an improvement in transfusion independence and hemoglobin in patients with myelofibrosis according to findings from a retrospective analysis of the phase 3 PERSIST-2 trial.

Treatment with GB2064 monotherapy for at least 6 months led to a reduction in collagen fibrosis of the bone marrow of at least 1 grade in 4 of 5 evaluable patients with myelofibrosis, according to topline findings from a planned intermediate assessment of the phase 2a MYLOX-1 trial.

The FDA has accepted for review a new drug application for 18F-rhPSMA-7.3, an investigational radiohybrid PSMA-targeted PET imaging agent for diagnostic imaging of prostate cancer, according to an announcement from Blue Earth Diagnostics.

Gavocabtagene autoleucel demonstrated positive topline results from the phase 1 portion of a phase 1/2 trial in patients with mesothelin-expressing solid tumors.

The FDA has approved bevacizumab-adcd, a bevacizumab biosimilar, for the treatment of six types of cancer.

Vinorelbine plus cyclophosphamide and capecitabine led to a significant improvement in time to treatment failure compared with paclitaxel alone in patients with estrogen receptor–positive, HER2-negative locally advanced or metastatic breast cancer.

Pembrolizumab plus chemotherapy demonstrated sustained improvements in progression-free survival and overall survival vs placebo plus chemotherapy in patients with treatment-naïve, metastatic squamous non–small cell lung cancer regardless of PD-L1 expression level.

Treatment with narsoplimab denoted high response rates and a significant improvement in laboratory thrombotic microangiopathy markers, translating to favorable overall survival in patients with hematopoietic stem cell transplantation–associated thrombotic microangiopathy.

In a 14 to 2 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the benefit-risk profile of melphalan flufenamide is not favorable for the approved indicated population of patients with relapsed/refractory multiple myeloma.

In a 9 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the benefits of poziotinib do not outweigh its risks for the treatment of patients with HER2 exon 20 insertion–mutated non–small cell lung cancer.

Alpelisib decreased the need for surgery and led to improvements in performance status and disease-related signs and symptoms in pediatric patients with PIK3CA-related overgrowth spectrum disease who received treatment with the PI3K inhibitor under compassionate use.

The FDA has granted an orphan drug designation to the novel PD-L1/4-1BB bispecific antibody ATG-101 for the treatment of patients with pancreatic cancer.

The FDA has granted an orphan drug designation to the novel autophagy/palmitoyl protein thioesterase-1 inhibitor ezurpimtrostat for the treatment of patients with cholangiocarcinoma.

The FDA has granted a fast track designation to envafolimab for the treatment of patients with locally advanced, unresectable, or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma who have progressed on 1 or 2 prior lines of chemotherapy.

Adjuvant nivolumab monotherapy elicited a statistically significant and clinically meaningful improvement in recurrence-free survival compared with placebo for patients with completely resected stage IIB/C melanoma.

Higher baseline and longitudinal evaluations of health-related quality of life prior to and during treatment with nivolumab and cabozantinib demonstrated an association with improved progression-free survival and overall survival in patients with advanced, treatment-naïve renal cell carcinoma.

Treatment with brexucabtagene autoleucel drove durable responses in patients with relapsed/refractory mantle cell lymphoma, particularly those with minimal residual disease negativity at 6 months.

Obinutuzumab, acalabrutinib, and venetoclax following optimal debulking with bendamustine failed to meet the prespecified rate of undetectable minimal residual disease in the peripheral blood at the end of induction treatment in patients with relapsed/refractory chronic lymphocytic leukemia.