The antibody–drug conjugate sacituzumab govitecan induced objective responses in about 30% of heavily pretreated patients with metastatic urothelial carcinoma in initial results of a phase II trial that were presented at the 2019 ESMO Congress.
A final analysis of part 1 of the phase III CheckMate 227 trial showed that nivolumab plus ipilimumab led to survival benefits in previously untreated patients with advanced non–small cell lung cancer, regardless of PD-L1 expression status.
In the phase III SPARTAN trial, the combination of androgen receptor apalutamide and androgen deprivation therapy led to an overall survival OS benefit compared with placebo/androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer, based on the updated findings presented at the 2019 ESMO Congress.
In his presentation on translational research in non–small cell lung cancer during the <em>20th Annual </em>International Lung Cancer Congress®, Scagliotti, a professor of oncology at the University of Torino in Italy, discussed the promising evolution of therapeutic options, pointing to steps being taken to create a larger precision medicine ecosystem.
The phase III FeDeriCa trial found that a fixed-dose subcutaneous injection of pertuzumab and trastuzumab with hyaluronidase in combination with intravenous chemotherapy was pharmacokinetically noninferior to the standard IV infusions of the regimen in patients with HER2-positive breast cancer.<br />
A hazard ratio for overall survival of 0.99 for tivozanib versus sorafenib in patients with refractory metastatic renal cell carcinoma, according to findings from the second prespecified analysis of the TIVO-3 trial, AVEO Oncology announced.
The United States Preventive Services Task Force is recommending that therapies like tamoxifen, raloxifene, or aromatase inhibitors be administered to women who have a high risk for developing breast cancer and low risk for the adverse events that may be caused by these therapies. This recommendation is part of an update to the USPSTF recommendation statement on treatments for reducing breast cancer risk.
Tissue-based microsatellite instability testing showed high concordance for detection of cell-free DNA, according to the results of a <em>Clinical Cancer Research</em> analysis.
Pexidartinib for the treatment of symptomatic tenosynovial giant cell tumor in adults has been approved by the FDA for patients with severe morbidity or functional limitations that are not responsive to improvement with surgery.
The combination of bempegaldesleukin and nivolumab was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.
Darolutamide has been approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer.
PF-05280586, a biosimilar for rituximab, has been approved by the FDA for use as a single-agent or in combination with chemotherapy for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma, or in combination with chemotherapy for patients with CD20-positive chronic lymphocytic leukemia.
Neratinib has received approval from Health Canada for the treatment of patients with early-stage, hormone receptor–positive, HER2-overexpressed/amplified breast cancer in the extended adjuvant setting. The agent should be given to patients 1 year after completing trastuzumab-based adjuvant therapy.<br />
The investigational agent SM-88 demonstrated promising survival in the phase II TYME-88-Panc study in patients with advanced pancreatic cancer.<sup>1,2</sup> The oral modified dysfunctional tyrosine induced a median overall survival of 6.4 months in patients.<br />
The frontline combination of daratumumab with lenalidomide and dexamethasone has been approved by the FDA for the treatment of patients with multiple myeloma who are ineligible for autologous stem cell transplantation.
The phase III IMspire170 trial failed to meet its primary endpoint according to topline results from the study. The combination of atezolizumab and cobimetinib did not improve progression-free survival compared with pembrolizumab in patients with previously untreated<em> BRAF </em>V600 wild-type melanoma.
A priority review designation has been granted by the FDA to a supplemental biologics license application for niraparib as a treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and who have either a <em>BRCA </em>mutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based regimen.
Topline results from the phase III CheckMate 459 trial revealed that the trial did not meet its primary endpoint of improved overall survival with nivolumab as compared with sorafenib for the treatment of patients with newly diagnosed, unresectable hepatocellular carcinoma.
Olaparib has been approved by the European Commission as a treatment in the maintenance setting for adult patients with advanced <em>BRCA1/2</em>-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following frontline treatment with a platinum-based chemotherapy.
An accelerated approval has been granted by the FDA to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.
ABP 980, a trastuzumab biosimilar, has been approved by the FDA for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.
Topline results from the ASCERTAIN trial of the cedazuridine and decitabine combination in patients with intermediate and high-risk myelodysplastic syndromes or chronic myelomoncyctis leukemia showed that the phase III trial met its primary endpoint. The fixed-dose combination demonstrated a decitabine exposure equivalence of total 5-day dosing compared with intravenous decitabine in the study patient population.
Pembrolizumab has been approved by the FDA as monotherapy for newly diagnosed patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 and for use in combination with platinum and fluorouracil for this patient population, irrespective of PD-L1 expression.
A supplemental new drug application has been approved by the FDA to update the label for gilteritinib (Xospata) to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory <em>FLT3</em>-mutant AML.
ARV-110, a PROTAC<sup>®</sup> protein degrader, has received a fast track designation from the FDA for the treatment of patients with metastatic castration-resistant prostate cancer who have disease progression following ≥2 systemic therapies.
Ruxolitinib (Jakafi) has received approval from the FDA as a treatment for adult and pediatric patients ≥12 years of age with steroid-refractory acute graft-versus-host disease.
The NovoTTF-100L System has received approval from the FDA in combination with pemetrexed and platinum-based chemotherapy as a frontline treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.
The combination of encorafenib, binimetinib, and cetuximab reduced the risk of death by 48% in patients wtih <em>BRAF</em> V600E-mutant metastatic colorectal cancer who have received up to 2 prior lines of therapy compared with cetuximab and irinotecan-containing regimens, according to the phase III BEACON CRC trial, which met both its primary endpoints.
Pembrolizumab monotherapy missed the prespecified primary endpoint of superior overall survival compared to chemotherapy in the phase III KEYNOTE-119 trial, in which the PD-1 inhibitor was being investigated as a second- or third-line treatment for patients with metastatic triple-negative breast cancer.
The combination of avelumab (Bavencio) and axitinib (Inlyta) has been approved by the FDA for the frontline treatment of patients with advanced renal cell carcinoma, based on findings from the phase III JAVELIN Renal 101 trial.