News

In an interview with Targeted Oncology, Aaron T. Gerds, MD, MS, discussed interim results from a phase II study of luspatercept as a treatment of anemia in patients with myelofibrosis, which he presented at the 2019 Annual Society of Hematology Annual Meeting.

First-line treatment with pembrolizumab in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients with metastatic triple-negative breast cancer who had PD-L1 expression in their tumors, meeting one of the coprimary end points of the phase III KEYNOTE-355 trial, according to the results of an interim analysis reported in a press release from Merck.

In an interview with Targeted Oncology, Allison J. Moskowitz, MD, discussed the treatment options for patients with Hodgkin lymphoma and what research is still to come in the field. She also compared the treatment landscape of Hodgkin lymphoma with that of T-cell lymphomas, a rare subset of patients.

The aurora A kinase inhibitor alisertib plus the class I histone deacetylase inhibitor romidepsin is a safe combination for the treatment of patients with relapsed/refractory lymphomas, according to the findings from a phase I study whose results were published by Paolo Strati, MD, and colleagues in Haematologica.

The combination of cabozantinib in combination with atezolizumab demonstrated encouraging efficacy and tolerability in patients with metastatic castration-resistant prostate cancer, according to the updated results of the phase Ib COSMIC-021 trial. The trial  is evaluating the combination in locally advanced or metastatic solid tumors, Elexis, Inc, announced in a press release.

In the community practice setting, patients with hepatocellular carcinoma who receive systemic therapy have a poor prognosis, which reveals an unmet need for more effective treatment options, according to a real-world retrospective observational study. The study aimed to show how treatment patterns related to the overall survival of patients with HCC throughout the United States.

A supplemental Biologics License Application for daratumumab in combination with carfilzomib and dexamethasone was submitted to the FDA for consideration as treatment for relapsed/refractory multiple myeloma, according to a press release from Janssen Pharmaceuticals.

The FDA granted Priority Review to the New Drug Application for capmatinib, an investigational selective MET inhibitor, which will be used as treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping-mutated non–small cell lung cancer, Incyte announced in a press release.

An FDA Fast Track Designation was granted to the first-in-class radioenhancer NBTXR3 with or without cetuximab for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy, according to a press release from Nanobiotix.

The FDA has granted approval to injectable pemetrexed for the treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer and for those with malignant pleural mesothelioma.

In an interview with Targeted Oncology, Justin F. Gainor, MD, discussed the significance of identifying RET alterations in patients with non-small cell lung cancer and the prevalence of this molecular target. He also highlighted data supporting further evaluation of BLU-667.

Next-generation sequencing in patients with chronic lymphocytic leukemia treated with the combination of chlorambucil and ofatumumab showed that the presence of TP53, SF3B1, and NOTCH1 mutations were predictive of reduced efficacy, according to the results of the phase III COMPLEMENT1 trial published in Haematologica.

A Biologics License Application for the investigational chimeric antigen receptor T-cell therapy agent, KTE-X19, was accepted by the FDA and granted Priority Review for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, according to a press release from Kite, developer of KTE-X19.^ 

A subgroup analysis of Korean patients from the pooled data of two global phase II trials, AURA extension and AURA2, has found that osimertinib is as safe and effective in this subgroup of patients with pretreated EGFR-mutated advanced non-small cell lung cancer with T790M positive status as it was in the parent trials.

An open, multicenter phase II trial of extend-release onapristone in patients with progesterone receptor–positive recurrent granulosa cell ovarian cancer, low-grade serous ovarian/primary peritoneal cancer, or endometroid endometrial cancer will demonstrate if the investigational drug will shrink or stop the cancer.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

The combination therapy of panobinostat and ruxolitinib was found to be safe and effective for the treatment of patients with primary myelofibrosis and post-polycythemia vera related myelofibrosis, and post essential thrombocythemia related myelofibrosis, according to the results of a dose-escalating,  phase I trial, which was published in Leukemia Research.

The combination of ilixadencel plus sunitinib has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma, Immunicum AB announced in a press release. The research update presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium showed a survival curve separation in the phase II MERECA trial that gives promising signals for the future.

The detection of circulating tumor DNA in human papillomavirus with an experimental blood test has been associated with high positive predictive value and negative predictive value for identifying disease recurrence in HPV-positive oropharyngeal cancer, according to a press release from the University of North Carolina Lineberger Comprehensive Cancer Center.

The FDA has extended the Prescription Drug User Fee Act date by 3 months for the new drug application of avapritinib from February 14, 2020, to May 14, 2020, the manufacturer, Blueprint Medicines Corporation, announced in a news release. The NDA was seeking accelerated approval for the kinase inhibitor for the treatment of adults with fourth-line gastrointestinal stromal tumors.

Tremelimumab monotherapy showed clinical activity with durable responses in patients with metastatic urothelial carcinoma and documented transitional cell carcinoma of the urothelium who failed first-line platinum-based chemotherapy, according to results from a phase II study, which is evaluating the drug in solid tumors.

The majority of patients with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia who were participants in a phase I/IIa trial had clinical responses to treatment with TAK-007, a cord blood–derived chimeric antigen receptor natural killer–cell therapy that targets CD19, with no major toxicities experienced by patients, according to a press release from the University of Texas MD Anderson Cancer Center.

Performing a liquid biopsy of circulating tumor cells may help identify patients who are at risk for node-positive melanoma relapse and identify patients who wish to avoid the toxicities associated with systemic adjuvant therapy, according to the results of a prospective study from The University of Texas MD Anderson Cancer Center, which was recently published in Clinical Cancer Research.

The incidence of colorectal cancer is rising among people who are below 50 years of age, the colonoscopy screening age as recommended by the United States Preventive Service Task Force of the National Cancer Institute. To date, there is no research that can explain the rise which has led physicians to deliberation on whether the recommended screening age for colonoscopies should be lowered or left as is. During a debate at the 2020 Gastrointestinal Cancers Symposium, Uri Ladabaum, MD, and David S. Weinberg, MD, MSc, presented their stances on the topic.

The combination of talimogene laherparepvec plus pembrolizumab led to a promising objective response rate in patients with advanced sarcoma who typically have limited treatment options, according to a phase II clinical trial&nbsp;&nbsp;published in&nbsp;<em>JAMA Oncology</em>.

Continuous dosing of the MEK inhibitor binimetinib plus buparlisib, a PI3K inhibitor, demonstrated promising activity as treatment of patients with ovarian cancer harboring either a&nbsp;RAS&nbsp;or&nbsp;BRAF&nbsp;mutation, according to results from a phase Ib clinical trial.

In an interview with&nbsp;Targeted Oncology, Daniel H.&nbsp;Ahn, DO, discussed the phase Ib/II study of onvansertib plus FOLFIRI and bevacizumab for the treatment of patients with metastatic colorectal cancer &nbsp;with a&nbsp;KRAS mutation.

Afatinib demonstrated clinical activity against uncommon and compound <em>EGFR</em> mutations in patients with EGFR tyrosine kinase inhibitor-naive non&ndash;small cell lung cancer, a patient population for which limited data exist on the efficacy of treatment with EGFR- tyrosine kinase inhibitors, according to Yang et al.

The addition of the dinutuximab injection to irinotecan did not improve overall survival in patients with relapsed/refractory small cell lung cancer, failing to meet the primary end point of the phase III DISTINCT trial, according to top-line results announced in a press release from United Therapeutics, developer of dinutuximab.

In an interview with&nbsp;Targeted Oncology, Noa Biran, MD, discussed the findings from 2 clinical trials evaluating consolidation therapy post-transplant in patients with high-risk multiple myeloma.