Sabrina Serani

The study will evaluate silmitasertib, a novel agent, for the treatment of pediatric and adult patients with relapsed/refractory solid tumors.

Following voluntary withdrawal in 2014, denileukin diftitox is now available again for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

The FDA has set a target action date of April 3, 2025, for the supplemental new drug application of cabozantinib for the treatment of neuroendocrine tumors.

LP-300, a novel small molecule, shows promise as a potential breakthrough treatment for advanced non–small cell lung cancer in never smokers.

Suresh S. Ramalingam, MD, discussed the practice-changing findings and implications of the phase 3 LAURA study investigating osimertinib for the treatment of patients with EGFR-mutated non–small cell lung cancer.

Gedeptin, a novel gene therapy, is entering phase 2 clinical trials to evaluate its efficacy in treating recurrent head and neck cancer.

While sacituzumab govitecan did not statistically improve overall survival vs docetaxel, there was a numerical improvement observed in patients with non–small cell lung cancer.

The FDA has granted an orphan drug designation to alemtuzumab, a chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia.

IMMN-001 significantly extended overall survival in patients with advanced ovarian cancer when combined with standard chemotherapy, according to phase 2 trial results.

Ayal Aizer, MD, MHS, discussed the changing treatment paradigms of treatment of brain metastases in patients with small cell lung cancer.

The phase 3 IDeate-Lung02 study has dosed its first patient with small cell lung cancer with the investigational antibody-drug conjugate infinatamab deruxtecan.

The Precision Promise and LAPIS studies failed to meet their primary end points of overall survival among patients with pancreatic cancer treated with the investigational agent pamrevlumab.

Dostarlimab plus chemotherapy has been approved for the treatment of all forms of advanced endometrial cancer, including mismatch repair-deficient and microsatellite stable tumors.

VCN-01 has been granted rare pediatric disease designation by the FDA for the treatment of retinoblastoma, a rare eye cancer.

Nicolas Girard, MD, PhD, discussed findings from the PALOMA-2 study investigating subcutaneous vs intravenous amivantamab plus lazertinib for previously untreated, EGFR-mutant non–small cell lung cancer.

Avutometinib plus defactinib shows promising early results in pancreatic cancer, earning an orphan drug designation from the FDA.

The investigational mRNA therapy BNT111 plus cemiplimab showed better overall response rates compared with historical controls in patients with stage III/IV melanoma refractory to anti-PD-(L)1 therapy.

The FDA has granted expanded access to TLX101-CDx, a promising PET imaging agent for diagnosing and monitoring glioma.

Findings from the phase 3 PERSEUS study support the approval of subcutaneous daratumumab and bortezomib, lenalidomide, and dexamethasone in this patient population.

A phase 1 trial of COM503 in metastatic or advanced solid tumors is expected to begin in Q4 2024.

The FDA granted priority review to asciminib for the treatment of newly diagnosed, Philadelphia chromosome-positive, chronic phase chronic myeloid leukemia.

Replacing fluorouracil with paclitaxel in combination with pembrolizumab and carboplatin appears to be efficacious and tolerable in patients with recurrent/metastatic head and neck cancer.

The combination of acalabrutinib and venetoclax with or without obinutuzumab improved survival vs standard chemotherapy in patients with previously untreated chronic lymphocytic leukemia.

The FDA approval of Guardant Shield marks the second blood-based diagnostic test for colorectal cancer in those age 45 and older at average risk of the disease.

Andrew Brohl, MD, discussed findings from a study investigating a novel vaccine treatment for squamous cell and Merkel cell carcinomas.

A new dendritic cell vaccine has shown promising results in extending survival for pancreatic cancer patients by stimulating the immune system to fight tumor cells.

A study suggests a PIK3CA mutation and blood tests before and after treatment may predict response to alisertib in HR+/HER2–metastatic breast cancer.

Mridula George, MD, discussed a study investigating ctDNA monitoring during neoadjuvant therapy of breast cancer.

The CAR T-cell therapy UCART22 has been granted orphan drug designation and rare pediatric drug designation from the FDA for the treatment of acute lymphoblastic leukemia.

Findings from the phase 2 NeoPembrOV study supported the addition of pembrolizumab to neoadjuvant chemotherapy before surgery in high-grade serous ovarian cancer.