News

A combination of nivolumab plus brentuximab vedotin was highly active in 73% of patients with relapsed/refractory primary mediastinal large B-cell lymphoma, based on results from the phase I/II CheckMate 436 trial, recently announced during the 15th International Conference on Malignant Lymphoma.<br /> &nbsp;

A complete response letter has been issued to&nbsp;Daiichi Sankyo from the FDA, alerting the company to the reasons why the new drug application for quizartinib as a&nbsp;treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia would not be approved.&nbsp;

A new meta-analysis quantifying the risks and benefits of using hydroxyurea to treat polycythemia vera found that while the incidence of thrombosis and acute myeloid leukemia were stable over time, mortality and transformation to myelofibrosis varied depending on follow-up duration.

The combination of venetoclax and bortezomib lead to an increased number of deaths by infection in patients with multiple myeloma in the phase III BELLINI trial, according to data presented at the 2019 EHA Congress. Deaths increased in spite of promising responses data and a high progression-free survival rate.

During an interview with <em>Targeted Oncology</em>, lead study author Dhruvajyoti Roy, PhD, the director of technology at Laboratory for Advanced Medicine, Inc., shared information about the study, commented on other liquid biopsy research presented by peers at ASCO and provided insight as to what these data mean for the future of cell-free DNA methylation.

The first regulatory approval has been granted to entrectinib in Japan. The Japanese&nbsp;Ministry of Health, Labour and Welfare recently&nbsp;approved the agent for the treatment of adult and pediatric patients with&nbsp;<em>NTRK&nbsp;</em>fusion&ndash;positive, advanced recurrent solid tumors.

Charles G. Mullighan, MBBS, MSc, MD, discussed with&nbsp;<em>Targeted Oncology&nbsp;</em>the role of genetic variants in understanding a patient&rsquo;s predisposition to ALL. He highlighted findings in research that may help in utilizing the current understanding of these genetic variants to make treatment decisions for patients with ALL.

In an interview with <em>Targeted Oncology</em>, Rory McCulloch, MD, discussed the results from a retrospective analysis for R-BAC treatment following relapse on a BTK inhibitor in patients with mantle cell lymphoma.

Olaparib has been approved by the European Commission as a treatment in the maintenance setting for adult patients&nbsp;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.

Two abstracts presented at the 2019 ASCO Annual Meeting analyzed potential combinations with osimertinib (Tagrisso), a third-generation EGFR TKI, with additional agents to potentially overcome resistance mutations following progression in patients with <em>EGFR</em>-mutant NSCLC.

In an interview with&nbsp;<em>Targeted Oncology</em>, Kazuhiko Nakagawa, MD, PhD discussed the findings from the RELAY trial for the combination of ramucirumab plus erlotinib compared to erlotinib plus placebo. He suggested that these data could be practice-changing for the treatment of newly diagnosed patients with&nbsp;<em>EGFR</em>-positive NSCLC.<br /> &nbsp;

Patients with early-stage, asymptomatic, newly diagnosed chronic lymphocytic leukemia showed improved survival outcomes with ibrutinib monotherapy compared with placebo, according to results from phase III CLL12 study presented at the 2019 European Hematology Association Congress.<br /> &nbsp;

Kartik Konduri, MD, discussed with a group of physicians in a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation the diagnostic workup and treatment considerations he makes when he sees a patient with non&ndash;small cell lung cancer in the clinic. Konduri explained his treatment decision making based on the case scenario of a patient with locally advanced NSCLC.&nbsp;

An accelerated approval has been granted by the FDA to&nbsp;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 &ge;1 other prior line of therapy.

New data from the phase II/III IMerge trial show that imetelstat may allow for transfusion independence for patients with debilitating anemia caused by myelodysplastic syndrome,&nbsp;according to results presented at the&nbsp;2019 EHA Congress.<br /> &nbsp;

When bevacizumab was added to capecitabine plus irinotecan, the combined regimen was shown to be a safe and effective second-line treatment option for patients with metastatic colorectal cancer, according to findings from a phase II trial published recently in the&nbsp;International Journal of Clinical Oncology.

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Andrew X. Zhu, MD, PhD, FACP, discussed the results from the REACH-2 trial and the significance of the approval of ramucirumab monotherapy in patients with advanced HCC and high AFP levels who have previously failed sorafenib.

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&nbsp; 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;