News

In an interview with Targeted Oncology, Nizar Bahlis, MD, discussed the updated findings from the MAIA trial, which he presented at the 2019 ASH Annual Meeting. He highlighted the updates to the PFS, OS, and overall response rate data, as well as some other areas daratumumab is under investigation now following the positive data from this trial. 

Individuals with obesity who were diagnosed with locally advanced or metastatic clear cell renal cell carcinoma achieved longer overall survival than patients of normal weight in select groups of an independent cohort study, which evaluated overall survival and the transcriptomic differences in the primary tumor and peritumoral adipose tissue in adult patients with metastatic clear cell renal cell carcinoma.

In a preliminary clinical trial, ARQ 531, an investigational Bruton tyrosine kinase inhibitor, showed safety and clinical activity across a variety of B-cell malignancies.

With the absence of a standard of care for chronic neutrophilic leukemia and atypical chronic myeloid leukemia, 2 rare BCR-ABL1-negative myeloid neoplasms, ruxolitinib may be a viable treatment option after a phase II study showed potential for response in this patient population.

In December 2019, the FDA approved a number of new treatments in lung cancer, pancreatic cancer, urothelial carcinoma, breast cancer, and prostate cancer. A tissue complete assay was also approved by the FDA for use in a clinical trial evaluating pembrolizumab.

During a Targeted Oncology tweet chat, Erika P. Hamilton, MD, and Stephanie Graff, MD, discussed treatment options and considerations for the case of a patient with ER-positive, HER2-negative breast cancer who relapsed on letrozole, an aromatase inhibitor.

Ado-trastuzumab emtansine has been approved by the European Commission for the treatment of adult patients with HER2-positive early breast cancer, in the adjuvant setting who have residual invasive disease after taxane-based chemotherapy  and HER2-targeted therapy, in the neoadjuvant setting.¹

Adult patients&nbsp;with&nbsp;deleterious or suspected deleterious&nbsp;germline&nbsp;<em>BRCA</em>-mutated metastatic pancreatic adenocarcinoma who have not had disease progression on at least 16 weeks of first-line platinum-based chemotherapy may now receive maintenance therapy with the&nbsp;PARP inhibitor olaparib, according to an approval from the FDA.

Osimertinib demonstrated a manageable toxicity profile and encouraging activity in patients with non&ndash;small cell lung cancer who harbor an uncommon EGFR mutation, according to results from a phase II clinical trial conducted in Korea.

In an interview with&nbsp;Targeted Oncology&nbsp;at the 2019 Ruesch Center Symposium, Benjamin Weingberg, MD, shared key points from his discussion on mining the microbiome in patients with colorectal cancer and summarized the treatment landscape for patients with metastatic disease. He also discussed an upcoming basket trial that uses liquid biopsies to place patients on treatment plans that will be most effective for their individual needs.

The combination of off-the-shelf, antibody-targeted natural killer cells and IL-15 superagonist N-083 with low-dose metronomic chemoradiation, adenoviral and year tumor-associated antigen vaccines, and a PD-L1 checkpoint inhibitor had ongoing durable complete responses in patients with triple-negative breast cancer who failed standard-of-care treatment, according to a press release from NantKwest Inc., manufacturer of the NK cell-based therapy.

Results from a phase II prospective trial indicate that fluorouracil-, leucovorin-, irinotecan-, and oxaliplatin-based treatment and imaging-based biomarkers for borderline resectable pancreatic ductal adenocarcinoma achieved a resection rate of 45% and a median overall survival of 2 years.<br /> &nbsp;

The Cchek Prostate Cancer Confirmation test&mdash;which utilizes artificial intelligence, flow cytometry, and liquid-biopsy technology to detect prostate cancer&mdash;has been commercially launched, according to Anixa Biosciences, Inc., developer of the test. Once it becomes available, this test will reduce the need for expensive and invasive biopsy procedures to diagnose patients with prostate cancer in certain patients.<br /> &nbsp;

Selpercatinib will be compared with the standard of care in the first ever phase III clinical trial in patients with advanced or metastatic treatment-na&iuml;ve&nbsp;<em>RET</em>&nbsp;fusion-positive non&ndash;small cell lung cancer, according to a press release from Eli Lilly and Company.

A trastuzumab biosimilar has officially been prequalified as the first biosimilar by the World Health Organization, which may be used for the treatment of breast cancers, according to a press release. The organization predicts this will be more affordable for patients and will, therefore, expand access to treatment.

Results from a phase I/Ib trial showed revealed that preliminary activity was seen with IMGN632, an investigational anti-CD123 antibody-drug conjugate, given to patients with relapsed/refractory acute myelogenous leukemia or blastic plasmacytoid dendritic cell neoplasm, according to data presented at the 2019 ASH Annual Meeting.

Recent study results suggest that guideline recommendations for biomarker testing in metastatic colon cancer are not consistent with real-world care. A retrospective review of the COTA Real World Data database showed suboptimal adherence to testing guidelines for RAS, BRAF, and microsatellite instability (MSI)/mismatch repair deficiency in this patient population.

Shekeab Jauhari, MD, a medical oncologist/hematologist, has been named principal investigator at the Florida Cancer Specialists &amp; Research Institute, and he will lead phase I clinical trials at the FCS Drug Development Unit in Lake Mary, Florida, at the Sarah Cannon Research Institute, which is the newest unit in the FCS that is set to open in January 2020.

The incidence of thyroid cancer in the United States may be on decline since the rise in thyroid cancer diagnoses observed between 1974 and 2013. This finding is based on observational analysis of data from the Surveillance, Epidemiology, and End Results 13 registry, which were recently published in JAMA.<br /> &nbsp;

In an interview with Targeted Oncology, Ian W. Flinn, MD, PhD, discussed the results from the ZUMA-2 trial which evaluated the efficacy and safety of KTE-X19, a CAR T-cell therapy, in patients with relapsed/refractory mantle cell lymphoma. He highlighted how unique this product is compared to other CAR T-cell therapies and where he believes it will fit into the treatment landscape for patients with mantle cell lymphoma.

Tucatinib developer, Seattle Genetics, Inc., has submitted a new drug application to the FDA for tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least 3 prior HER2-directed drugs alone or in combination with other drugs, in the neoadjuvant, adjuvant, or metastatic setting, according to a press release.<br /> &nbsp;

A new drug application for selinexor has been submitted to the FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma who have had at least 2 prior multi-drug therapies,and who are ineligible for stem cell transplantation, including chimeric antigen receptor T-cell therapy, according to a press release from Karypharm Therapeutics, developer of selinexor.<br /> &nbsp;

The first half-yearly follow-up&nbsp;results from a phase I study of ilixadencel monotherapy in patients with advanced gastrointestinal stromal tumors will be presented by Alex Karlsson-Parra, MD, PhD on February 6, 2020, during poster session A, at the Clinical Immuno-Oncology Symposium, according to a press release from Immunicum AB, where Karlsson-Parra serves as the chief executive officer.<br /> &nbsp;

Older patients with mantle cell lymphoma were more likely to have a maintained response with induction rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone followed by rituximab maintenance when compared against R-CHOP and interferon-alpha maintenance.

Fam-trastuzumab deruxtecan-nxki has been granted an accelerated approval by the FDA for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least 2 prior lines of anti&ndash;HER2-based regimens in the metastatic setting.

A biologics license application has been submitted to the FDA for margetuximab in combination with chemotherapy for the treatment of patients with metastatic HER2-positive breast cancer, according to a press release from MacroGenics, Inc.<br /> &nbsp;

A Biologics License Application has been submitted to the FDA for ABP 798, a biosimilar candidate for rituximab, announced Amgen and Allergan, who are collaborating on 4 biosimilar agents together, in a press release.

The target number of patients with advanced gastrointestinal stromal tumors have been enrolled in the phase III VOYAGER study in China, which is evaluating the safety and efficacy investigational drug avapritinib in the third- or fourth-line settings, according to a press release from CStone Pharmaceuticals.<br /> &nbsp;

The FDA has granted a&nbsp;<a>priority review designation to the new drug application&nbsp;</a>for UGN-101 for the potential treatment of patients with low-grade upper tract urothelial cancer, UroGen Pharma Ltd., announced in a press release.

A new study has found that enzalutamide given with androgen deprivation therapy significantly reduced the risk of metastatic progression or death in men with metastatic hormone-sensitive prostate cancer versus placebo plus ADT, including patients with low-volume disease and/or prior docetaxel therapy.<br /> &nbsp;