News

Based on findings from the phase III CheckMate-238 trial, nivolumab (Opdivo) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, according to Bristol-Myers Squibb, the developer of the PD-1 inhibitor.

Treatment with&nbsp;trifluridine/tipiracil combined with bevacizumab improved&nbsp;progression-free survival over capecitabine plus bevacizumab in patients with&nbsp;metastatic colorectal cancer who are not eligible for chemotherapy or surgical resection,&nbsp;according to findings presented at the 20th World Conference of Gastrointestinal Cancer.&nbsp;<br /> &nbsp;

Based on data from the phase II BRIGHT 1003 study, the FDA has granted a priority review to a new drug application for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia, according to Pfizer, the developer of the investigational oral smoothened inhibitor.

William B. Donnellan, MD, was recently promoted to director of Leukemia/Myelodysplastic Syndrome Research at the Sarah Cannon Research Institute in Nashville, Tennessee. Donnellan has served as an investigator of hematologic malignancies since 2014 at the Sarah Cannon Research Institute.

Regorafenib (Stivarga) improved overall survival and progression-free survival compared with lomustine (Gleostine) for patients with glioblastoma that recurred following surgery and treatment with the Stupp regimen, according to updated results presented in a poster at the 2018 ASCO Annual Meeting.

Bert H. O&rsquo;Neil, MD, recently shared his considerations for treatment when treating patients with gastrointestinal cancers. O&rsquo;Neil reviewed how he would treat patients with colon cancer and patients with hepatocellular carcinoma based on case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives presentation.<br /> &nbsp;

The combination of&nbsp;the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) has been approved by the FDA&nbsp;for the treatment of patients with<em>&nbsp;BRAF</em>-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.&nbsp;The approval is based data from the phase III COLUMBUS trial.

In findings from the&nbsp;randomized phase III SOLO-1 trial, olaparib (Lynparza) tablets&nbsp;reduced the risk of disease progression or death compared with placebo as frontline maintenance therapy for women with <em>BRCA</em>-positive advanced ovarian cancer.

The anticancer immunotherapy vaccine SL-701, when used with immunostimulants, induced antitumor activity in patients with relapsed/refractory glioblastoma both alone and in combination with bevacizumab, according to updated phase II results from the 2-stage STML-701-0114 trial presented at the 2018 ASCO Annual Meeting.

Alexander Drilon, MD, discusses findings from the phase I LIBRETTO-001 study on the safety of LOXO-292 for the treatment of patients with RET-altered cancers.

According to phase I findings recently published in the<em> New England Journal of Medicine,&nbsp;</em>^&nbsp;the&nbsp;recombinant oncolytic poliovirus PVSRIPO demonstrated&nbsp;a 2- and 3-year overall survival (OS) rate of 21% (95% CI, 11%-33%) for patients with recurrent grade IV malignant glioblastoma.

Overall survival and progression-free survival were improved with the combination of frontline atezolizumab with chemotherapy&nbsp;compared with chemotherapy alone in patients with extensive-stage small cell lung cancer, meeting the coprimary endpoints of the phase III IMpower133 trial.

Joseph F. Renzulli Jr, MD, an expert in robotic surgery for treating urologic cancers, is joining Lawrence and Memorial Hospital, an affiliate of Yale New Haven Health, in New London, Connecticut. He brings a specialized insight on diagnosing and treating prostate cancer to the growing team.

Overall survival was not improved with the combination of palbociclib and fulvestrant compared with&nbsp;fulvestrant and placebo in the phase III PALOMA-3 trial for patients with HR-positive, HER2-negative metastatic breast cancer who received prior endocrine therapy, according to Pfizer, the developer of the CDK4/6 inhibitor.

A supplemental&nbsp;biologics license application for the use of pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma has been accepted by the FDA,&nbsp;according to Merck, the manufacturer of the PD-1 inhibitor.

An overall response rate of 60% was induced with venetoclax (Venclexta) monotherapy in&nbsp;patients with poor-risk relapsed/refractory mantle cell lymphoma who were previously treated with&nbsp;a BTK inhibitor,&nbsp;according to results presented at the 2018 European Hematology Association Congress.&nbsp;Of the responding patients, 20% had a complete response.

A supplemental new drug application for ibrutinib in combination with rituximab has been granted a priority review by the FDA. According to Pharmacyclics and Janssen Biotech, the codevelopers of ibrutinib, this combination could be a treatment option across all lines of therapy for patients with Waldenstr&ouml;m macroglobulinemia.

According to long-term follow-up data from the phase III CLL11 study, treatment with obinutuzumab combined with chlorambucil&nbsp;reduced the risk of death by 24% versus rituximab plus chlorambucil in treatment-na&iuml;ve patients with chronic lymphocytic leukemia with comorbidities. These findings were presented&nbsp;at the 2018 European Hematology Association Congress.

A&nbsp;supplemental biologics license application has been accepted by the FDA seeking approval for&nbsp;the combination of nivolumab plus ipilimumab for the frontline treatment of patients with advanced non&ndash;small cell lung cancer with tumor mutational burden&nbsp; &ge;10 mutations per megabase, according to Bristol-Myers Squibb, the manufacturer of both immune checkpoint inhibitors.

In patients with untreated advanced-stage classical Hodgkin lymphoma, PET can be safely used to&nbsp;guide treatment after 2 cycles of&nbsp;upfront de-escalated BEACOPP, according to the final analysis of the&nbsp;phase III LYSA study presented at the 2018 European Hematology Association Congress.

John Marshall, MD, recently shared the treatment considerations and decisions he makes when treating patients with gastrointestinal (GI) cancers. Marshal, chief of the Division of Hematology/Oncology, director of the Otto J. Ruesch Center for the Cure of GI Cancer, Medstar Georgetown University Hospital, in Washington, DC, explained his treatment decisions based on a case scenario during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.

The Hutchinson Institute for Cancer Outcomes Research released the first Community Care Cancer in Washington State: Quality and Cost Report to provide transparency for patients and health providers, establishing a more value-based care model.

The FDA has added PD-L1 status to the&nbsp;labels for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma. The addition was made&nbsp;based on lower overall survival rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1&ndash;low expressing platinum-eligible urothelial carcinoma.

The 16-gene Leukemic-MCL16 (L-MCL16) Assay reliably distinguished between classic and indolent mantle cell lymphoma subtypes in patients with leukemic presentation, according to results published in <em>Blood</em>. Combined with genomic complexity, the assay was prognostic for overall survival.

Promising antitumor activity was seen in patients with&nbsp;heavily pretreated HER2-positive breast cancer with or without brain metastases with the use of tucatinib in combination with capecitabine, trastuzumab, or both agents, according to phase Ib findings published in <em>The Lancet Oncology</em>.

Matthew S. Davids, MD, MMSc,&nbsp;discusses the findings with duvelisib plus fludarabine-cyclophosphamide-rituximab as a frontline therapy for&nbsp;younger patients with CLL, as well as the potential future for this agent in the treatment of patients with CLL.

Based on survival data from the phase III TOWER study, blinatumomab has been granted full marketing authorization by the&nbsp;European Commission for&nbsp;the treatment of adult patients with Philadelphia&nbsp;chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia,&nbsp;according to Amgen, the developer of the anti-CD19 immunotherapy.

Pembrolizumab (Keytruda) induced a median overall survival (OS) of 32.7 months versus 15.9 months for ipilimumab (Yervoy) in patients with unresectable stage III-IV melanoma, according to 4-year survival results from the KEYNOTE-006 trial presented at the 2018 ASCO Annual Meeting.

Christa Dominick, MD, a gynecologic oncology fellow at University Hospitals, discusses the rationale behind this trial and the results. She also highlights her plans moving forward with other trials involving the cowpea mosaic virus in ovarian cancer.<br /> &nbsp;

Michael R. Grunwald, MD,&nbsp;discusses new and emerging agents in AML and ALL, as well as sequencing and toxicity challenges with these treatments.<br /> &nbsp;