News

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

In the HER2CLIMB trial, the addition of tucatinib to trastuzumab and capecitabine significantly improved progression-free survival in patients with locally advanced, unresectable, or metastatic HER2-positive breast cancer, meeting the primary endpoint of the study, according to a press release from Seattle Genetics.<br /> &nbsp;

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.

In an interview with&nbsp;Targeted Oncology&nbsp;at the ILCA conference, Rimola, radiologist, Radiology Department, Barcelona Clinic Liver Cancer Group, University of Barcelona, explained how assessment criteria may change patterns of progression and ultimately change outcomes in patients with advanced HCC treated with nivolumab.

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 triplet combination of abemaciclib, trastuzumab, and fulvestrant showed a significant statistical improvement in progression-free survival compared with chemotherapy and trastuzumab in patients with heavily pretreated, hormone receptor&ndash;positive, HER2-positive breast cancer, according to the results of the phase II monarcHER trial.

The lack of approved therapies to target EGFR exon 20 insertion mutations, the third most common form of EGFR mutations, led to the study of osimertinib in combination with cetuximab in patients with advanced EGFR-mutant non&ndash;small cell lung cancer.<br /> &nbsp;

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.

In an interview with Targeted Oncology, Amit Singal, MD, MS,&nbsp;discussed issues with surveillance in patients with NASH, with or without cirrhosis. He also highlighted how combatting these issues can help improve the survival of patients with NASH-related HCC.

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.

In an interview with Targeted Oncology, Kristen M. Pettit, MD, discussed the data supporting the FDA&rsquo;s fast track designation of the novel agent IMG-7289 for the treatment of patients with MF.

TAS-102 improved overall survival in patients with metastatic gastric/gastroesophageal junction cancer, regardless of prior gastrectomy, according to a preplanned subgroup analysis from the phase III TAGS trial published in&nbsp;<em>JAMA Oncology</em>.<br /> &nbsp;

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.

Patients with treatment-na&iuml;ve EGFR-mutant non&ndash;small cell lung cancer experienced a statistically significant and clinically meaningful improvement in progression-free survival with the combination of ramucirumab and erlotinib compared with erlotinib alone, according to the results of the phase III RELAY trial which was recently published in The Lancet Oncology.