News

Patients with tissue tumor mutational burden-high solid tumors represent a subset of patients who could have a robust tumor response to the immune checkpoint inhibitor pembrolizumab as monotherapy, suggesting tTMB may be a novel and useful predictor of response in patients with previously treated recurrent or metastatic advanced solid tumors, including thyroid cancer.

The sustainability of efficacy and safety with frontline ibrutinib-based therapy used to treat patients with chronic lymphocytic leukemia who have TP53 aberrations was demonstrated, according to 4-year follow-up result of a pooled analysis.

The FDA granted 2 Fast Track designations to the cavrotolimod for 2, including in combination with anti-PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma who are refractory to prior anti-PD-1 blockade and in combination with anti-PD-1/PD-L1 in patients with locally advanced or metastatic cutaneous squamous cell carcinoma who are refractory to prior anti-PD-1/PD-L1 blockade.

Erika P. Hamilton, MD, discusses the rationale for exploring OP-1250 monotherapy in an open-label first-in-human multi center phase 1/2 study in adult patients with advanced and/or metastatic hormone receptor-positive, HER2-negative breast cancer.

Patients with ROS1-positive non–small cell lung cancer who have resistance to the ROS1 and ALK inhibitor crizotinib had intracranial and systemic responses to brigatinib, according to findings from a small cohort of patients.

In an interview with Targeted Oncology, Nina Shah, MD, discussed the findings from the KarMMA study supporting the use of idecabtagene vicleucel as treatment of patients with multiple myeloma.

The first patient with newly diagnosed glioblastoma multiforme has been dosed with the first-in-class small molecule enzastaurin in combination with temozolomide and radiotherapy in the phase 3 ENGAGE clinical trial with an aim of determining the overall survival outcome of the drug in this patient population.

The FDA granted an Orphan Drug designation to the novel immunotherapy PVSRIPO for the treatment of patients with advanced melanoma of stage IIB-IV.

Ten-year overall survival is low among patients with acute myeloid leukemia , but an analysis demonstrated that survival is shorter for older patients treated with chemotherapy alone, according to published findings.

Noelle G. Cloven, MD, discussed the current cervical cancer treatment paradigm, the unmet needs that still remain to be addressed, and encouraging new directions of research in clinical trials in honor of Cervical Cancer Awareness Month.

The FDA has updated the Prescribing Information for the approved agent darolutamide to include improvement in overall survival in patients with non-metastatic castration-resistant prostate cancer, as well as other secondary end point data, from the phase 3 ARAMIS clinical trial.

A review of the trending news in oncology online for the week of January 8, 2021, including recent news from the FDA on the cancer treatment paradigm, updates in oncology, and the latest information regarding COVID-19.

The FDA has granted a Fast Track designation to zenocutuzumab as a potential treatment option for patients with metastatic solid tumors harboring NRG1 gene fusions that have progressed on standard of care therapy.

Rituximab added to standard anthracycline-based chemotherapy demonstrated significant improvements in progression-free survival as well as overall survival as treatment of patients with follicular lymphoma, according to 35-year follow-up results of patients treated through the Nebraska Lymphoma Study Group.

In an interview with Targeted Oncology, Vanessa Kazanietz, MD, discussed the findings from a study exploring the correlation between thyroid toxicity and response to immunotherapy as treatment of patients with metastatic non-small cell lung cancer.

Eganelisib, an investigational PI3K-gamma inhibitor in combination with nivolumab, demonstrated promising efficacy compared with nivolumab alone as treatment of platinum-refractory, immunotherapy naïve patients with advanced metastatic urothelial cancer, according to updated findings from the phase 2 MARIO-275 clinical trial.

The role of immunotherapy, HIF-2α inhibitors, and CDK4/6 inhibitors appear encouraging for the treatment of patients with kidney cancer following recent research on targeting von Hippel-Lindau disease-associated renal cell carcinoma.

The investigational selective JAK1 inhibitor, DZD4205, led to anti-tumor activity when given as treatment of patients with relapsed or refractory peripheral T-cell lymphoma , according to results from the phase 1/2 JACKPOT8 clinical trial.

VGX-3100, a therapeutic DNA vaccine, achieved a 25% reduction or more reduction in HPV-16/18-associated vulvar high-grade squamous intraepithelial lesion in 63% of patients at 6 months after treatment with the agent, according to findings from an open-label phase 2 clinical trial.

The FDA lifted the partial clinical hold that was placed on a phase 2 study of MT-401 as treatment of patients with post-transplant acute myeloid leukemia.

Pazopanib, a tyrosine kinase inhibitor, is active and well-tolerated in patients with poor-risk metastatic clear cell renal cell carcinoma with no new safety signal observed, according to results from the phase 4 FLIPPER clinical trial.

An Independent Data Monitoring Committee has recommended the pivotal phase 3 SIERRA study continue as planned to full enrollment of 150 patients based on the findings from a pre-planned ad hoc interim analysis of the study.

Treatment with the combination of eprenetapopt and azacitidine did not improve complete responses in patients with TP53-mutant myelodysplastic syndromes.

The FDA deferred action on the Biologics License Application for the potential biosimilar of bevacizumab, MYL-1402O, due to travel restrictions related to COVID-19 that prohibited the agency from completing an inspection of the manufacturing facility, as required by the standard review process.

The FDA has granted a Breakthrough Therapy designation to tiragolumab in combination with atezolizumab for the frontline treatment of patients with metastatic non – small cell lung cancer whose tumors have high PD-L1 expression and no EGFR or ALK genomic aberrations.

In an interview with Targeted Oncology, Richard S. Finn, MD, discussed the real-world data from the REFINE study, which is exploring the outcomes of patients with unresectable hepatocellular carcinoma who received treatment with regorafenib.

The FDA granted a Fast Track designation to ARX788 as a single agent for the treatment of patients with advanced or metastatic HER2-positive breast cancer who received at least 1 prior anti-HER2 regimen in the metastatic setting.

Treatment with telaglenastat in combination with cabozantinib did not improve progression-free survival in patients with advanced or metastatic renal cell carcinoma when compared with cabozantinib alone, missing the primary end point of the phase 2 CANTANA clinical trial.

The FDA has granted an Orphan Drug Designation to annamycin for the treatment of patients with soft tissue sarcomas.

Bristol Myers Squibb has withdrawn the indication of nivolumab for the treatment of patients with small cell lung cancer who had disease progression after a platinum-based chemotherapy and at least 1 other line of therapy from the US market following a consultation with the FDA.