Kristi Rosa

A panel of experts discuss some of the encouraging data on emerging modalities in melanoma presented during the 2020 ASCO Virtual Scientific Program and share how they might apply that information to clinical practice.

The FDA has granted a priority review designation to a new drug application (NDA) for trilaciclib for the treatment of patients with small cell lung cancer (SCLC) who are being treated with chemotherapy.

The combination of dabrafenib and trametinib elicited favorable response rates in a mixed histology cohort of pretreated patients with solid tumors, lymphomas, and multiple myeloma whose tumors harbored a BRAF V600 mutation.

The FDA’s Oncologic Drugs Advisory Committee voted 8 to 2 in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

Debio 1143 in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy was found to induce a statistically and clinically significant improvement in overall survival compared with CRT alone in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.

The independent data safety monitoring committee has unanimously recommended that the phase 3 OVAL trial examining VB-111 in patients with platinum-resistant ovarian cancer continue as planned.

Nivolumab in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma

Nivolumab, following neoadjuvant chemoradiation and complete surgical resection, resulted in a statistically significant improvement in disease-free survival in patients with resected esophageal or gastroesophageal junction cancer.

The FDA has issued a complete response letter to Fennec Pharmaceuticals regarding its new drug application for a unique formulation of sodium thiosulfate (Pedmark) for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.

Treatment with afatinib followed by osimertinib resulted in a median overall survival benefit of almost 4 years in US patients with EGFR T790M–positive non–small cell lung cancer in the real-world setting.

The anti–PD-L1 monoclonal antibody CS1001 in combination with platinum-based chemotherapy led to a significant improvement in progression-free survival when used as a frontline treatment for patients with stage IV squamous and nonsquamous non–small cell lung cancer.

Ensartinib showed a significant improvement in progression-free survival over crizotinib with a favorable safety profile in patients with ALK-positive non–small cell lung cancer.

The FDA has granted a priority review designation to a new drug application for a unique formulation of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.

The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.

Atezolizumab in combination with paclitaxel did not demonstrate a statistically significant improvement in progression-free survival as a first-line treatment for patients with PD-L1–positive triple-negative breast cancer, failing to meet the primary end point of the IMpassion131 trial.

A CD30-targeted CAR T-cell therapy was found to elicit a high rate of durable complete responses (CRs) in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma.

The FDA has cleared the clonoSEQ® assay to identify and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.

The biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for use in pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been submitted to the FDA under the agency’s Rolling Review process.

Lorlatinib significantly improved progression-free survival in treatment-naive patients with advanced ALK-positive non–small cell lung cancer versus crizotinib, meeting the primary end point of the phase 3 CROWN trial.

Celsion Corporation will continue to follow patients with hepatocellular carcinoma enrolled on the phase 3 OPTIMA trial examining ThermoDox® in combination with radiofrequency ablation for overall survival.

China’s National Medical Products Administration has granted priority review status to a new drug application for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor who received previous treatment with 3 or more kinase inhibitors, including imatinib.

The FDA has granted a fast track designation for aspacytarabine as treatment for acute myeloid leukemia in adults aged 75 years or older who have comorbidities that preclude the utilization of intensive induction chemotherapy.

Tisagenlecleucel was found to elicit clinically meaningful activity in patients with relapsed/refractory follicular lymphoma, meeting the phase 2 ELARA trial’s primary end point of complete response rate.

The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 as a treatment for patients with pancreatic cancer.

The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

The advent of gene expression assays has provided predictive insight into chemotherapy benefit that can be combined with prognostic information yielded by gene expression profiling to better target patients with breast cancer who are at higher clinical risk for the use of adjuvant chemotherapy.

The FDA has approved atezolizumab (Tecentriq) in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) in the treatment of patients with BRAF V600 mutation–positive advanced melanoma.

As new data emerge in the melanoma treatment paradigm, new questions have come to light regarding neoadjuvant/adjuvant strategies, reduced dosing for immunotherapy combinations, and approaches following progression on, or resistance to, PD-1 inhibition.

The FDA has granted breakthrough therapy designation to pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes.

The FDA has accepted 2 supplemental biologics applications for pembrolizumab in patients with triple-negative breast cancer; these are the first US applications for the anti–PD-1 therapy in breast cancer.