News

Sorafenib in combination with hepatic arterial infusion chemotherapy demonstrated an improvement in overall survival compared with sorafenib alone for patients with hepatocellular carcinoma and portal vein invasion, according to the results of a randomized phase III trial.

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.

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Phillipe Moreau, MD, discussed the findings from the phase III CASSIOPEIA trial and the potential role for daratumumab in patients with newly diagnosed multiple myeloma in combination with standard-of-care VTd before SCT.

During a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation, Tanios Bekaii-Saab, MD, discussed with a group of physicians the treatment options for patients with gastrointestinal cancers and the characteristics that influence his decision making. Bekaii-Saab explained his clinical decisions based on the case scenario of one patient with colorectal cancer and one with hepatocellular carcinoma.

A review of patients with advanced non&ndash;small cell lung cancer treated in a community practice setting demonstrated that not all patients recommended for receiving genomic testing are being appropriately tested for potential genetic drivers of disease.<br /> &nbsp;

One set of researchers are exploring the possibility of re-challenging patients with ovarian cancer with PARP inhibitors later in the course of treatment when their disease became recurrent. As the first to examine re-challenging patients with PARP inhibitors, researchers found that patients who had prior exposure to PARP inhibitors did not develop resistance and could, therefore, receive repeat treatment with PARP inhibitors.

<em>Targeted Oncology</em>&nbsp;spoke with experts in attendance at the 2019 ASCO Annual Meeting to review what they believed were some of the biggest takeaways from this year&#39;s presentation across the fields of lung cancer, breast cancer, GI cancers, genitourinary cancers, melanoma, and multiple myeloma.

Combined treatment with ibrutinib and venetoclax was shown to be a safe and effective first-line oral regimen for high-risk and older patients with chronic lymphocytic leukemia, according to findings from an open-label phase II trial published recently in the<em> New England Journal of Medicine</em>.<br /> &nbsp;

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Emese Zsiros, MD, PhD, discussed the findings from this phase II trial investigating the triplet regimen in patients with recurrent disease. In addition, she shared details for the next steps planned for this regimen.

Topline results from the ASCERTAIN trial of the&nbsp;cedazuridine and decitabine combination in patients with&nbsp;intermediate and high-risk myelodysplastic syndromes or chronic myelomoncyctis leukemia showed that the&nbsp;phase III trial met its primary endpoint. The fixed-dose combination demonstrated a&nbsp;decitabine exposure equivalence of total 5-day dosing compared with intravenous decitabine in the study patient population.&nbsp;

Pembrolizumab has been approved by the FDA as monotherapy for newly diagnosed patients with&nbsp;metastatic or unresectable recurrent head and neck squamous cell carcinoma&nbsp;whose tumors express PD-L1 and for use in combination with platinum and fluorouracil for this patient population, irrespective of PD-L1 expression.

In an interview with&nbsp;<em>Targeted Oncology</em>, Paul L. Crispen, MD, discussed several ongoing trials for patients with bladder cancer focused on the importance of bladder preservation. He also highlighted a clinical trial currently enrolling at the University of Florida Health for patients with upper tract disease.

Polatuzumab vedotin in combination with&nbsp;bendamustine and rituximab has been granted an accelerated approval from the FDA for the&nbsp;treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.<br /> &nbsp;

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

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.