News

For detecting genetic drivers and molecular aberrations in patients with metastatic non–small cell lung cancer, performing biopsies with comprehensive cell-free DNA, or liquid biopsies, may be a viable substitute for tissue-based biopsies. 

In an interview with <em>Targeted Oncology</em>, Naval G. Daver, MD, discussed the possibility of combination therapy in patients with AML. He highlights some of the most recent data to come out for this patient population, including for those harboring a <em>TP53</em> or <em>FLT3</em> mutation.

Preliminary results from a phase II trial demonstrated promising activity for brigatinib in patients with non&ndash;small cell lung cancer with an&nbsp;<em>ALK&nbsp;</em>rearrangement who have progressed on treatment with another next-generation ALK tyrosine kinase inhibitor.

The FDA has granted a fast track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.<br /> &nbsp;

Patients with chronic lymphocytic leukemia showed high responses when given a combination of acalabrutinib and obinutuzumab, which targets BTK and the CD20 antigen. High response rates over 90% were seen across various settings of disease, according to the results of a small, preliminary trial.

Based on the results from a phase III SOPHIA clinical trial, the HER2-targeted antibody, margetuximab, was superior to trastuzumab in improving progression-free survival in patients with pretreated HER2-positive metastatic breast cancer. In CD16A-158F carriers, the PFS was significantly enhanced.<br /> &nbsp;

A phase III trial has begun for the investigational agent pemigatinib in comparison with gemcitabine and cisplatin chemotherapy for the treatment of newly diagnosed patients with metastatic or surgically unresectable cholangiocarcinoma who have activating <em>FGFR2 </em>rearrangements. The first patient has already been treated with the selective FGFR inhibitor in the open-label, randomized FIGHT-302 trial, according to a press release from Incyte, the company developing the agent.

The FDA has accepted a biologics license application for the investigational agent luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes&ndash;associated anemia who have ring sideroblasts and require red blood cell transfusions, and for the treatment of adult patients with beta-thalassemia&ndash;associated anemia who require RBC transfusions. In addition, a priority review designation was granted for the beta-thalassemia indication.<br /> &nbsp;

Findings from a cohort of the&nbsp;phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket study revealed that heavily pretreated patients with&nbsp;metastatic breast cancer and high mutational burden benefited from pembrolizumab monotherapy.&nbsp;

The treatment of&nbsp;<em>EGFR</em>-mutant non&ndash;small cell lung cancer has experienced significant improvements with the&nbsp;development of tyrosine kinase inhibitors, but resistance mechanisms that promote disease recurrence have tampered the runaway success of these revolutionary agents, said&nbsp;Katerina A. Politi, PhD, during the 2019 ASCO Annual Meeting. Early findings are presented for 2 novel agents aiming to potentially overcome resistance.&nbsp;

According to the latest Annual Report to the Nation on the Status of Cancer, cancer death rates have declined in men, women, and children across all cancer types, and have continued to decline between 1999 and 2016. In a special section of this year&rsquo;s report, however, data show that both cancer incidence and death rates were higher in women aged 20 to 49 compared to male counterparts.

The novel bispecific antibody ZW25 has been granted a fast track designation by the FDA for the treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma to be used in combination with standard-of-care chemotherapy.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.

A new drug application for&nbsp;tazemetostat was submitted to the FDA for the treatment of patients with&nbsp;epithelioid sarcoma who are not eligible for curative surgery, according to Epizyme, the&nbsp;manufacturer of the EZH2 inhibitor.

Copanlisib has been granted with a breakthrough therapy designation from the FDA for the&nbsp;treatment of adult patients with relapsed marginal zone lymphoma who have received at least 2 prior therapies.

Aziz Nazha, MD, discusses the different agents being explored for patients who have progressed on ruxolitinib, and why this is a significant unmet need. He also highlights the role of genetics in patients with MF and how a better understanding can help guide treatment decisions.

A supplemental new drug application has been approved by the FDA&nbsp;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^&reg; protein degrader, has received a fast track designation from the FDA for the treatment of patients with&nbsp;metastatic castration-resistant prostate cancer who have disease progression following &ge;2 systemic therapies.

Patients with aggressive papillary thyroid cancer may be good candidates for treatment with anti&ndash;PD-(L)1 immunotherapy due to elevated levels of serum PD-L1, according to findings from a new study presented during the 2019 AACR-AHNS Head and Neck Cancer Conference.

The FDA has granted a fast track designation to the investigational agent lasofoxifene for the treatment of women with estrogen receptor-positive, HER2-negative metastatic breast cancer who have an ESR1 mutation. The agent is currently being investigated in a phase II trial in this setting.

John M. Burke, MD, reviews the treatment options he considers when treating a patient with chronic lymphocytic leukemia and the factors that sway his clinical decisions.

The R²&nbsp;regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) has been approved by the FDA for the treatment of patients&nbsp;with previously treated follicular lymphoma and marginal zone lymphoma, based on findings from the&nbsp;phase III AUGMENT trial.

Dostarlimab (TSR-042), an&nbsp;investigational anti&ndash;PD-1 therapy, demonstrated durable responses across subgroups of patients with&nbsp;microsatellite instability&ndash;high and microsatellite stable advanced or recurrent endometrial cancer, according to results&nbsp;from the phase I/II GARNET study.

Olga K. Weinberg, MD, discusses how genomic testing has evolved over the years and how she envisions the role of NGS will change as more is learned about genetic mutations.&nbsp;

Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

The combination of sorafenib plus gemcitabine and oxaliplatin demonstrated &ldquo;moderate&rdquo; benefits compared with sorafenib monotherapy in patients with advanced hepatocellular carcinoma, according to findings from an open-label phase II trial recently published in the <em>British Journal of Cancer.</em>

Ruxolitinib (Jakafi) has received approval from the FDA as a treatment for&nbsp;adult and pediatric patients &ge;12 years of age with&nbsp;steroid-refractory acute graft-versus-host disease.

Rami S. Komrokji, MD, explains the diagnostic and molecular workup behind myeloproliferative neoplasm diagnoses and discusses treatment options based on the case scenario of a patient with myelofibrosis.

The FDA has granted a breakthrough therapy designation to novel tumor-infiltrating lymphocyte therapy LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical cancer who have progressed on or after chemotherapy.