African American males with prostate cancer may fare better in terms of overall survival than Caucasian males, according to the results of a pooled analysis of phase III data. The data were obtained through the PROCEED registry, which includes over 1900 patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T, created at the recommendation of the FDA.
The phase III JAVELIN 100 trial of avelumab plus chemoradiotherapy versus standard-of-care CRT in patients with locally advanced head and neck squamous cell carcinoma has been terminated due to doubt that the combination will meet the primary end point, progression-free survival.
The FDA has granted a Fast Track designation for the evaluation of balstilimab in combination with zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer, according to a press release from Agenus, Inc., the developer of balstilimab. Comprehensive data supporting the potential of the combination served as the basis for the designation.
The FDA has recommended that a preliminary meeting for a potential Breakthrough Therapy designation be requested for leronlimab as a treatment of patients with metastatic triple-negative breast cancer, based on positive data from a phase Ib/II study.
The largest prospective dataset in previously untreated diffuse large B-cell lymphoma revealed the molecular heterogeneity of diffuse large B-cell lymphoma with potential treatment targets harbored by the cell-of-origin subtypes, based on data from a phase III GOYA study. <br />
The FDA has placed a partial clinical hold on the phase I trial of ACTR707 in combination with rituximab in patients with relapsed/refractory B-cell lymphoma from Unum Therapeutics, following the submission of a safety report from the company. The FDA notified Unum of the hold verbally on March 4. Unum Therapeutics acknowledged the partial clinical hold in filings with the Securities and Exchange commission.
Acelarin demonstrated clinical activity in patients with platinum-resistant ovarian cancer who were heavily pretreated with at least 3 lines of chemotherapy, according to preliminary results from part 1 of phase II PRO-105 study, announced in a press release from the drug developer, NuCana plc.
The FDA has granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
The FDA granted Breakthrough Therapy designation to JNJ-61186372 for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy.
The combination of elotuzumab plus lenalidomide and dexamethasone did not demonstrate a statistically significant improvement in progression-free survival compared with lenalidomide and dexamethasone alone in newly diagnosed patients with multiple myeloma who are transplant ineligible, missing the primary end point of the phase III ELOQUENT-1 trial.<br />
Despite evidence from previous studies that showed that platinum-based chemotherapy agents are active in patients with breast cancer, platinum-based chemotherapy was not found to be superior to standard chemotherapy in terms of eliciting pathologic complete responses in patients with HER2-negative breast cancer carrying a BRCA mutation, according to data from the INFORM trial published in the Journal of Clinical Oncology.
The FDA granted Orphan Drug Designation to umbralisib, an investigational oral PI3K delta inhibitor as treatment for patients with follicular lymphoma, according to a press release from TG Therapeutics. This designation follows a New Drug Application for treatment of marginal zone lymphoma and follicular lymphoma, which was submitted to the FDA in October 2019, based on results from the phase IIb UNITY-NHL study.
The combination of fulvestrant and capivasertib prolonged progression-free survival compared with placebo in patients with estrogen receptor-positive breast cancer who were previously treated with aromatase inhibition, according to results from the phase II FAKTION trial, published in The Lancet Oncology.
In an interview with Targeted Oncology, Van K. Morris, MD, discussed a pooled analysis of the TRIBE trials to determine how oligometastatic disease status impacts treatment decisions. He also discussed advances in the field, including novel treatments that are emerging for advanced CRC.
In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.
The FDA has granted Fast Track Designation to AL101, an injectable small molecule gamma secretase inhibitor, as treatment of patients with recurrent or metastatic adenoid cystic carcinoma. The designation follows an Orphan Drug Designation granted in May of 2019 for treatment of ACC, Ayala Pharmaceuticals, Inc. announced in a press release.
The combination of venetoclax plus low-dose cytarabine did not demonstrate a statistically significant improvement in overall survival compared with LDAC plus placebo in patients with acute myeloid leukemia who were ineligible for intensive chemotherapy at the time of a planned analysis, missing the primary end point of the phase III VIALE-C trial.
The FDA has approved the combination of isatuximab-irfc with pomalidomide and dexamethasone as treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Treatment with pembrolizumab resulted in a statistically and clinically significant improvement in progression-free survival compared with brentuximab vedotin in adults patients with relapsed or refractory classical Hodgkin lymphoma , meeting a dual primary end point of the phase III KEYNOTE-204 trial, according to the interim analysis results announced in press release from Merck.
The FDA has granted Priority Review to the newly accepted Biologics License Application for tafasitamab and lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The Prescription Drug User Fee Act target action date was set as August 30, 2020, with no plans for an advisory committee meeting to discuss the application.
In an interview with Targeted Oncology, Jason Westin, MD, MS, FACP, discussed the pros and cons of administering R-CHOP in the frontline setting of diffuse large B-cell lymphoma. He also discussed other options for patients who have limited responses to the standard-of-care.
High volumes of mutations observed through liquid biopsies may be associated with an improvement in progression-free survival and clinical benefit after first-line standard-of-care pembrolizumab-based therapy in patients with metastatic non-small cell lung cancer, according to findings from a prospective biomarker trial conducted by investigators at the University of Pennsylvania Perelman School of Medicine and Abramson Cancer Center, which were published in Clinical Cancer Research.
Data from 3 phase I/II clinical trials confirm that larotrectinib is a highly active agent for the treatment of TRK fusion-positive advanced solid tumors and is feasible for long-term use, according to a pooled analysis recently published in The Lancet Oncology.
The FDA has granted Breakthrough Therapy Designation for Debio 1143, an inhibitor of apoptosis proteins, for the treatment of patients with a confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin-based concomitant standard fractionation chemoradiation, the current standard of care, announced Debiopharm in a press release.<br />
The FDA Oncologic Drugs Advisory Committee agreed that ramucirumab plus erlotinib showed a favorable benefit/risk profile in patients with untreated metastatic EGFR-positive non–small cell lung cancer in the phase III RELAY study. The vote was 6 to 5 in favor of the combination and ODAC has scheduled a hearing to discuss the terms of the Biologic License Application.<br />
Researchers at the Fox Chase Center have identified MRCKA, a serine/threonine-protein kinase, as a target for treating high-grade serous ovarian carcinoma, the most lethal of gynecologic malignancies, for which few targeted therapies exist. The research was recently published in Science Signaling, Fox Chase announced in a press release.
The FDA has granted Priority Review to the New Drug Application for brigatinib as first-line treatment for patients with ALK-positive metastatic non–small cell lung cancer as detected by an FDA-approved test, Takeda Pharmaceutical Company announced in a press release.
Treatment with immune checkpoint inhibitors appears to elicit limited clinical activity in patients with osteosarcoma. In a study, investigators at MD Anderson Cancer Center found that certain factors like poor infiltration of the tumor by immune cells, low activity from available T cells, a lack of immune-stimulating neoantigens, and multiple immune-suppressing pathways may interfere with response to immunotherapy in these patients, according to a press release from the organization.<br />
Preliminary results from a safety and tolerability phase I/II study signal promise for ADXS-503 alone and in combination with pembrolizumab as treatment of patients with metastatic squamous and non-squamous non–small cell lung cancer, Advaxis, Inc, announced in a press release. Findings were presented during the International Association for the Study of Lung Cancer 2020 Targeted Therapies of Lung Cancer Meeting, February 19-22, 2020, in Santa Monica, California.
In an interview with Targeted Oncology at the 2020 Transplantation & Cellular Therapy Meetings, Craig Sauter, MD, discussed the retrospective real-world review of patients with hematologic malignancies who developed cytopenia post-chimeric antigen receptor T-cell therapy.