Lisa Astor

According to results from the phase III DANUBE bladder cancer trial, neither of the co-primary end points of the trial were met. The combination of durvalumab, and tremelimumab did not show an improvement in overall survival in treatment-naïve patients with unresectable, stage IV bladder cancer. Also, durvalumab alone failed to show an OS benefit over standard-of-care chemotherapy alone in patients with high PD-L1 expression.

Changes in the tumor microenvironment following progression on EGFR tyrosine kinase inhibitor therapy suggest a potential for benefit from PD-1/PD-L1 inhibitors in patients with EGFR-positive non–small cell lung cancer, according to the results of a retrospective study published in Clinical Cancer Research.

The FDA has granted a fast track designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas, according to a press release from Kura Oncology, Inc. The fast track designation includes patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with a T follicular helper phenotype.

Treatment with immunotherapy has become ingrained in the standard of care for treating patients with melanoma, but investigators continue to research new combinations and treatment strategies that can improve patients outcomes. One approach that has generated a great deal of interest and is a significant focus of ongoing trials involves adjuvant and neoadjuvant therapy, according to Jeffrey S. Weber, MD, PhD.

Tumor mutational burden has generated interest as a potential biomarker of response to immunotherapy and has already been examined in the context of several lung cancer trials to gauge its utility.

The FDA has approved acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma as either an initial or subsequent therapy.

The FDA has accepted a Biologics License Application (BLA) for SB8, a biosimilar candidate to reference bevacizumab that was submitted by Samsung Bioepis in September 2019, according to a press release from the company.

The FDA has granted an accelerated approval to zanubrutinib for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.

The FDA has approved luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who need regular red blood cell transfusions.

Following a meeting with the FDA, AVEO Oncology has decided to push back the planned New Drug Application submission for tivozanib to the first quarter of 2020 and to narrow for the proposed indication for tivozanib to the treatment of relapsed or refractory renal cell carcinoma, according to a press release from the company.

With so many advances occurring in the field of lung cancer and guidelines changing on an almost monthly basis, keeping up with the latest best practices has become more challenging for many oncologists. The 17th Annual Winter Lung Cancer Conference™ taking place February 7-9, 2020, in Miami, Florida, seeks to inform oncologists and healthcare professionals about the most up-to-date research and management suggestions.

Umbralisib monotherapy demonstrated positive responses in patients with previously treated follicular lymphoma, meeting the primary end point for the follicular lymphoma cohort of the phase IIb UNITY-NHL trial, TG Therapeutics announced in a press release.

Durvalumab in combination with tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in previously untreated patients with stage IV non–small cell lung cancer, according to findings from the final PFS analysis of the phase III POSEIDON trial.

The FDA plans to split up the submitted New Drug Application for avapritinib into 2 separate NDAs in the treatment of 2 different populations of patients with gastrointestinal stromal tumors, according to a press release from Blueprint Medicines.

Ublituximab in combination with ibrutinib demonstrated a benefit in progression-free survival over ibrutinib monotherapy, as assessed by an independent review committee, in patients with high-risk relapsed or refractory chronic lymphocytic leukemia in the final long-term results of the phase III GENUINE trial.

An updated Biologics License Application has been submitted to the FDA for eflapegrastim for the treatment of neutropenia in patients with cancer receiving myelosuppression drugs, according to a press release from Spectrum Pharmaceuticals.

The FDA has approved niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with ≥3 prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positivity.

The FDA has approved a supplemental New Drug Application for a single dose of aprepitant injectable emulsion for intravenous use in patients receiving moderately emetogenic chemotherapy. The approval expands the dose for aprepitant to include a 130 mg single-dose regimen for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.<br /> &nbsp;

Nivolumab in combination with low-dose ipilimumab and concomitant chemotherapy demonstrated a benefit in overall survival compared with chemotherapy alone in patients with previously untreated advanced non&ndash;small cell lung cancer, according to interim results from the CheckMate -9LA trial.

Atezolizumab and bevacizumab demonstrated a statistically significant improvement in both progression-free survival and overall survival compared with sorafenib in patients with unresectable hepatocellular carcinoma who have not received previous systemic therapy; this met both of the co-primary endpoints of the phase III IMbrave150 trial.

Ivosidenib in combination with azacitidine demonstrated promising efficacy in addition to being well tolerated in patients with newly diagnosed <em>IDH1</em>-mutant acute myeloid leukemia who were ineligible for intensive chemotherapy.

The FDA has approved a supplemental biologics license application for an updated indication expanding the use of romiplostim in the treatment of adult patients with immune thrombocytopenia to include newly diagnosed patients and patients with persistent ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

The FDA has accepted and granted a priority review to a biologics license application for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer.

In a&nbsp;Targeted Oncology&nbsp;case-based peer perspectives live discussion with a group of physicians, Corey J. Langer, MD, reviewed the potential for treatment with immunotherapy following chemoradiotherapy for patients with stage III non&ndash;small cell lung cancer. Langer discussed these options based off of a case scenario of a patient with stage IIIA lung adenocarcinoma.

Ruxolitinib demonstrated a significant improvement in overall response rate over best available therapy at day 28 in patients with steroid-refractory acute graft-versus-host disease, according to topline results from the phase III REACH2 trial.&nbsp;Novartis, the company developing the JAK inhibitor, announced in a press release that this met the primary endpoint of the trial.

A phase III trial, HER2CLIMB-02, has been initiated to investigate the combination of tucatinib and ado-trastuzumab emtansine in patients with locally advanced or metastatic HER2-positive breast cancer.&nbsp;The results of the trial will support registration for tucatinib in the United States.

The FDA has granted a fast track designation to navicixizumab for the treatment of patients with high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received &ge;3 prior therapies and/or prior bevacizumab.

The FDA has granted duvelisib with an orphan drug designation for the treatment of patients with T-cell lymphoma, according to a press release from Verastem Oncology, the company developing duvelisib.<br /> &nbsp;

The FDA has granted a breakthrough therapy designation to niraparib for the treatment of patients with <em>BRCA1/2</em>-mutated metastatic castration-resistant prostate cancer who have previously received taxane chemotherapy and androgen receptor&ndash;targeted therapy.

The FDA has approved a labeling supplement for neratinib for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer. The labeling supplement adds safety information based on interim findings from the phase II CONTROL trial, which investigated the use of preventive strategies to reduce the incidence and severity of neratinib-associated diarrhea.