Caroline Seymour

The FDA has released a complete response letter to its biologics license application resubmission, indicating that it needs more data to support approval for remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease.

The FDA has granted an orphan drug designation to ABM-1310 for the treatment of patients with BRAF V600–mutant glioblastoma.

Catherine C. Coombs, MD, and Alexey Danilov, MD, PhD, moderate a discussion on the role and sequencing of BTK inhibitors, venetoclax-based regimens, and CAR T-cell therapy in mantle cell lymphoma and chronic lymphocytic leukemia.

Prexigebersen in combination with decitabine and venetoclax demonstrated potent antitumor activity when used in the treatment of patients with newly diagnosed and relapsed/refractory acute myeloid leukemia.

Tony S.K. Mok, MD, BMSc, FRCPC, FASCO, highlights novel partners and potential new approaches for immunotherapy-based regimens for the treatment of patients with non–small cell lung cancer.

New agents in development including ABBV-011 and BL-B01D1 seek to turn the tides of relapsed extensive-stage small cell lung cancer; although chemoimmunotherapy has earned its right as the frontline standard of care, both classes of agents have yet to demonstrate benefit in second or later lines.

Positive event-free survival data from the phase 3 AEGEAN, NEOTORCH, and KEYNOTE-671 trials add further evidence to the benefit of perioperative immunotherapy in early-stage non–small cell lung cancer but have yet to show clear biomarkers of response beyond PD-L1.

The FDA has issued a ‘safe to proceed’ for the investigational new drug application enabling a phase 1 study evaluating NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-cell receptor natural killer cell therapy for patients with relapsed/refractory multiple myeloma.

Oral treatment with BMF-219 led to 2 complete responses of 5 patients with relapsed/refractory acute myeloid leukemia with menin-dependent mutations, both of which remain on treatment.

The China National Medical Products Administration has accepted and granted priority review to the biologics license application seeking the approval of loncastuximab tesirine-lpyl for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors have a PD-L1 combined positive score of at least 1.

The allogeneic CAR T-cell therapy CB-010 demonstrated early signs of durable antitumor activity and favorable safety in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Amivantamab-vmjw plus carboplatin and pemetrexed led to a clinically meaningful and statistically significant improvement in progression-free survival vs carboplatin and pemetrexed alone in patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion–mutated non–small cell lung cancer.

Higher levels of baseline TCR clonality in peripheral blood mononuclear cells (PBMCs) and baseline IgG1 fraction in PBMCs and tumor tissue were identified in an institutional cohort of samples from patient with metastatic renal cell carcinoma.

Neoadjuvant immunotherapy–based combinations led to reductions in tumor size and pathologic necrosis at the time of cytoreductive nephrectomy in patients with metastatic renal cell carcinoma.

Leap Therapeutics has launched the randomized, controlled part B of the phase 2 DeFianCe trial, which will evaluate DKN-01 in combination with bevacizumab and chemotherapy as second-line therapy in patients with advanced colorectal cancer.

Lindsay Kilburn, MD, discusses key efficacy findings from the phase 2 FIREFLY-1 trial of the investigational type II RAF inhibitor tovorafenib (DAY101) in heavily pretreated pediatric patients with low-grade glioma.

ONC-392/BNT316 demonstrated early signs of antitumor activity and manageable safety in patients with metastatic, PD-(L)1–resistant non–small cell lung cancer.

Durvalumab plus a single priming dose of tremelimumab led to continued clinically meaningful overall survival benefit at 4 years compared with sorafenib in patients with previously untreated, unresectable hepatocellular carcinoma not eligible for localized therapy.

The European Commission has granted an orphan drug designation to Temferon for the treatment of patients with glioma, joining glioblastoma multiforme in its designation.

The addition of the CXCL12 inhibitor NOX-A12 to standard frontline therapy with radiation and bevacizumab led to an overall survival rate of 83% at a median follow-up of 15 months in patients with glioblastoma.

The FDA has granted an orphan drug designation to VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for the treatment of patients with pancreatic cancer.

Treatment with NKX101 led to a best composite complete response rate of 67% in patients with relapsed/refractory acute myeloid leukemia, according to updated data from a dose-expansion cohort of an ongoing phase 1 trial.

The FDA has approved the first and only iodine-based contrast agent iopromide-300, -370 injection for intra-arterial and intravenous contrast-enhanced mammography.

The FDA has granted an orphan drug designation to the orally bioavailable, reversible small molecule EGFR inhibitor ERAS-801 for the treatment of patients with malignant glioma, including glioblastoma.

Epcoritamab has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for B-cell Lymphomas in the third- or later-line setting for the treatment of patients with diffuse large B-cell lymphoma, including patients with disease progression after transplant or CAR T-cell therapy, and as a category 2A preferred regimen for patients with histologic transformation of indolent lymphoma to DLBCL with no intention to proceed to transplant, including patients with disease progression after transplant or CAR T-cell therapy.

Fixed-duration therapy with venetoclax plus obinutuzumab led to 60% reduction in the risk of progression or death compared with chlorambucil plus obinutuzumab, with benefit seen regardless of TP53 or IGHV mutation status, in previously untreated patients with chronic lymphocytic leukemia.

Zanubrutinib plus obinutuzumab and venetoclax demonstrated lasting responses characterized by sustained progression-free survival and undetectable minimal residual disease in peripheral blood and bone marrow in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.