News

In solid tumors, targeted therapies are scarce for patients with mutations like KRAS or fusions like NRG1. Two clinical trials are investigating novel agents targeting these alterations to improve outcomes in patients with these particular genetic drivers of disease. The research was recently presented at the 2019 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

The phase III VOYAGER study may soon introduce a new treatment option for patients with locally advanced metastatic or unresectable gastrointestinal stromal tumors, a patient population with an unmet need for novel agents that are durable and can target specific drivers. The trial is looking at the efficacy of novel drug avapritinib versus standard-of-care regorafenib.<br /> &nbsp;

During a recent&nbsp;Targeted Oncology&nbsp;live case-based peer perspectives event, Olga Frankfurt, MD, discussed the complications that could development during the treatment of patients with graft-vs-host disease. Frankfurt explained these complications in the context of a patient who develops acute GVHD after undergoing hematopoietic cell transplant.&nbsp;

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.

Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of tafasitamab with lenalidomide had a statistically significant and superior objective response rate compared with lenalidomide monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma who were not eligible for high-dose chemotherapy and stem cell transplant, announced MorphoSys AG, the manufacturer of tafasitamab, in a press release.

In an interview with&nbsp;<em>Targeted Oncology</em>, Catherine Sinclair, MD, discussed the importance of early detection in patients with thyroid cancer. She also highlighted surgical decisions for these patients and how she makes these choices for each patient.

In an interview with&nbsp;Targeted Oncology, Jia Ruan, MD, PhD, examined the evolving treatment landscape for mantle cell lymphoma. She also discussed modern strategies like precision medicine and ctDNA liquid biopsy that are aiding the evolution.

A new exploratory study has found that increased levels of&nbsp;plasma VEGF-A and serum thyroglobulin adversely affected clinical outcomes in patients with radioactive iodine-refractory differentiated thyroid cancer, although no biomarker successfully predicted sorafenib response. This study, which was published recently in&nbsp;Clinical Cancer Research, was a retrospective analysis conducted using samples from the earlier phase III DECISION trial.

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&ndash;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.

In an interview with&nbsp;Targeted Oncology, Hannah Linden, MD, discussed the current treatment landscape during Breast Cancer Awareness Month. She also highlighted the value of liquid biopsy, tissue biopsy, and imaging techniques in this space for identifying patients with targetable mutations and how these assays and techniques can further impact treatment and outcomes of these patients.

In an interview with&nbsp;Targeted Oncology, Raoul S. Concepcion, MD, discussed the existing challenges with implementing genetic testing and genetic counseling in community practices and how they can potentially be addressed.

According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant&nbsp;manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.

Atezolizumab as monotherapy or in combination with platinum-based chemotherapy may improve progression-free survival in patients with locally advanced or metastatic urothelial carcinoma, based on the <a href="https://www.targetedonc.com/conference/esmo-2019/firstline-atezolizumabchemotherapy-improves-outcomes-in-metastatic-urothelial-cancer">results from the phase III IMvigor130 trial</a>.

In the phase II biomarker-driven trial combining retinoic acid receptor alpha agonist SY-145 with azacitidine, newly diagnosed adult patients with RARA-positive acute myeloid leukemia who were unfit for intensive chemotherapy continued to show responses to the combination and demonstrate tolerability of the regimen, according to a press release from Syros Pharmaceuticals.

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.

In an interview with <em>Targeted Oncology</em>, at the Lynn Sage Breast Cancer Symposium, Susan Domchek, MD, explained the meaning of low to moderate penetrance genes and how they are indicative of breast cancer risk. She also explained the importance of germline and genetic testing to reveal mutations in these genes.&nbsp;

During a <em>Targeted Oncology </em>live case-based peer perspectives live discussion, Anna C. Pavlick, DO, MS, explained to a group of physicians best practices for the diagnosis and management of patients with metastatic melanoma. Pavlick, discussed treatment options between immunotherapy and targeted therapy based on the case scenario of a patient with <em>BRAF </em>wild-type metastatic melanoma.

In an interview with <em>Targeted Oncology</em>, Suresh S. Ramalingam, MD, deputy director of Winship Cancer Institute of Emory University, discussed the updated OS results from the FLAURA trial and evaluated the role of osimertinib in patients with <em>EGFR-</em>mutant NSCLC. He also highlighted some next steps with research for this patient population, such as the potential combination of osimertinib with other agents.

Margetuximab, an investigational monoclonal antibody, prolonged survival in pretreated patients with HER2-positive metastatic breast cancer when combined with chemotherapy, according to the second interim analysis of the phase III SOPHIA trial, which was reported in a press release from MacroGenics.<br /> &nbsp;

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

The combination of onvansertib, a third-generation adenosine triphosphate inhibitor, with FOLFIRI and bevacizumab achieved positive responses in patients with metastatic colorectal cancer in the second-line setting, according to the results of a phase Ib/II reported in a press release from Trovagene, Inc.<br /> &nbsp;

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;

Bemcentinib, a first-in-class AXL inhibitor, has been approved for a fast track designation by the FDA for the treatment of elderly patients with relapsed or refractory acute myeloid leukemia, according to a press release from BerGenBio.<br /> &nbsp;

Target resequencing and DNA profiling of purified tumor samples collected from younger patients with mantle cell lymphoma found that mutations of <em>KMT2D</em> and disruption of <em>TP53</em> by deletion or mutation were associated with an increased risk of progression and death, both in univariate and multivariate analysis, from standard treatments, according to a study published recently in <em>Haematologica</em>.<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.

In an interview with <em>Targeted Oncology</em>, Dr. Miles, discussed the importance of early detection for patients with thyroid cancer. He also highlighted how the treatment options differ for patients with disease that is caught early on versus those with more advanced and aggressive diseases, such as anaplastic thyroid cancer.<br /> &nbsp;

During a&nbsp;Targeted Oncology&nbsp;tweet chat, Naveen Pemmaraju, MD, and Aaron Gerds, MD, MS, led a discussion on a patient case with myelofibrosis. They reviewed the options from a Twitter poll and how they would approach treatment of this particular patient.

The phase I/II CIRLL trial has opened an expansion cohort to include patients with mantle cell lymphoma in the study of the monoclonal antibody, cirmtuzumab, plus ibrutinib. The study was previously open to patients with chronic lymphocytic leukemia and small lymphocytic leukemia only.¹