News

A supplemental Biologics License Application has been submitted to the FDA for the combination of atezolizumab and bevacizumab or the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy, according to a press release from Roche.

Cetuximab plus mFOLFOX6 with the addition of avelumab resulted in an overall response rate of 81% in patients with RAS/BRAF-wildtype metastatic colorectal cancer, according to results of the phase II AVETUX study that were presented during the 2020 Gastrointestinal Cancers Symposium. But despite promising tumor responses, the trial missed its primary progression-free survival end point.

Atezolizumab failed to meet the primary end point, disease-free survival, as adjuvant monotherapy in patients with muscle-invasive urothelial cancer compared with observation in the phase III IMvigor010 clinical trial, according to a press release from Roche, developer of the drug.

Accelerated approval has been granted by the FDA to the methyltransferase inhibitor tazemetostat for the treatment of metastatic or locally advanced epithelioid sarcoma in adult and adolescent patients who are not eligible for complete resection.<br /> &nbsp;

A phase Ib/II clinical trial of the experimental anti-mitochondrial drug devimistat in combination with cisplatin and gemcitabine has been initiated in patients with biliary tract cancer, according to a press release from Rafael Pharmaceuticals, Inc. The company will collaborate with Michigan Medicine to proceed with the randomized multicenter clinical trial.

Myriad Genetics, Inc, has submitted a supplementary premarket approval application to the FDA for the myChoice CDx test for use in predicting outcomes for women with frontline platinum-responsive advanced ovarian cancer who are treated with niraparib, a PARP inhibitor, according to a press release from Myriad Genetics, Inc., the manufacturer of the test.

Neoadjuvant systemic therapy may enable patients with triple-negative breast cancer who are ineligible for breast conservation therapy to become eligible, according to a prespecified secondary analysis of the results from the phase III BrighTNess trial.

Entrectinib led to clinically meaningful responses in patients with NTRK-fusion-positive solid tumors, according to results from a pooled analysis of the phase I ALKA-372-001, the phase I STARTRK-1, and the phase II STARTRK-2 studies.

In an interview with&nbsp;Targeted Oncology, Benjamin Besse, MD, PhD,&nbsp;<a>discussed&nbsp;</a>the research around the Tedopi vaccine and how it addresses an unmet medical need for the treatment of patients with non-small cell lung cancer who have failed immune checkpoint inhibitors. He also explained the use of genomic testing to aid the treatment of non-small cell lung cancer.

In an interview with&nbsp;Targeted Oncology, Jennifer Woyach, MD, discussed the rationale for evaluating a response-dependent treatment discontinuation strategy for older patients with previously untreated chronic lymphocytic leukemia. She highlighted the importance of determining an optimal discontinuation strategy in this patient population.

Dasatinib, a second-generation Abl-tyrosine kinase inhibitor, used concurrently with an intensive chemotherapy regimen yields superior outcomes compared with imatinib plus chemotherapy in pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia, according to the results from the first randomized phase III clinical trial comparing the 2 drugs in this patients&nbsp;<a>population</a>.

In an interview with&nbsp;Targeted Oncology, Richard Kim, MD, discussed the research from several trials that support the use of doublet and triplet regimens as treatment of patients with metastatic colorectal cancer harboring a&nbsp;BRAF&nbsp;mutation.

Bemcentinib in combination with pembrolizumab demonstrated clinical efficacy in the stage 1 portion of a phase II trial, which evaluated the combination in patients with non&ndash;small cell lung cancer who progressed on prior immune checkpoint inhibition, meeting the primary end point of the study.

The FDA has granted a Fast Track Designation to the immune-gene therapy Oncoprex in combination with the EGFR inhibitor osimertinib for the treatment of patients with&nbsp;<em>EGFR</em>-mutant non&ndash;small cell lung cancer who have progressed after treatment with osimertinib alone.

The FDA granted Priority Review to the Biologics License Application for belantamab mafodotin, an anti&ndash;B cell maturation antigen monoclonal antibody for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapies included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, GlaxoSmithKline plc announced in a press release.<br /> &nbsp;

Durvalumab and tremelimumab have been granted Orphan Drug Designation for the treatment of hepatocellular carcinoma, according to a press release from AstraZeneca.

A new phase III trial has found that luspatercept reduced the severity of anemia in patients with transfusion-refractory, lower-risk myelodysplastic syndromes with ring sideroblasts. Results from the MEDALIST trial, which included data from 65 sites in 11 countries, were published recently in the New England Journal of Medicine.

The FDA has granted a Priority Review to the New Drug Application for olaparib as treatment for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent, AstraZeneca reported in a press release.

In an interview with&nbsp;Targeted Oncology, Pier Francesco Ferrucci, MD, discussed the findings from the updated analysis, which he shared in a presentation at the 16th International Congress of the Society for Melanoma Research, highlightening the important takeaways from this follow-up analysis.

The Investigational New Drug Application for the novel EGFR tyrosine kinase inhibitor BBT-176 was cleared by the FDA for treatment of&nbsp;EGFR C797S&ndash;mutant non&ndash;small cell lung cancer, according to a press release from Bridge Biotherapeutics, Inc, developer of BBT-176.

Lenvatinib demonstrated a longer median overall survival compared with palliative therapy in patients with stage IVC anaplastic thyroid cancer, a rare disease for which the survival rate has not improved in roughly 20 years. The introduction of targeted therapy to the treatment landscape for anaplastic thyroid cancer has been challenging in the past because some patients do not have time to undergo therapy on a clinical trial because the process is time-consuming, and the procedure for study enrollment may exceed time to progression.

Ruxolitinib plus low-dose&nbsp;pegylated interferon-a2 improved peripheral blood cell counts, bone marrow cellularity and fibrosis, and symptom burden with acceptable toxicity in patients with polycythemia vera or proliferative myelofibrosis, according to the 2-year, end-of-study results of the phase II COMBI study, which were recently published in Haematologica.

In an interview with&nbsp;Targeted Oncology, Ruben Mesa, MD, discussed the findings from the pooled analysis of fedratinib at full dose in patients with myelofibrosis who had baseline platelet counts below 100 X 10⁹/L. He also highlighted other agents and therapies that appear promising for the treatment of patients with myeloproliferative neoplasms.

For patients with non&ndash;small cell lung cancer, having a body mass index &ge;30 at baseline could be independently associated with an improvement in overall survival with atezolizumab and could be considered a stratification factor in immune checkpoint inhibitor trials, according to a study published in JAMA Oncology.

In an interview with&nbsp;Targeted Oncology, Steven H. Kirtland, MD, FCCP, discussed the different factors that play a role in the decline of lung cancer mortality over the last few years. He highlighted how these advancements will continue to impact the survival of patients with lung cancer and his thoughts on the evolving landscape.

In an interview with&nbsp;Targeted Oncology,&nbsp;Pasi A. J&auml;nne, MD, PhD,&nbsp;discussed the current treatment landscape for patients with&nbsp;EGFR-mutant lung cancer, as well as some therapies that currently are under both preclinical and clinical investigation at the Dana-Farber Cancer Institute. He shared advice for community oncologists treating this patient population.

In an interview with&nbsp;Targeted Oncology, John M. Burke, MD, discussed the ongoing phase Ib First-MIND clinical trial of tafasitamab in combination with R-CHOP with or without lenalidomide as treatment of patients with newly diagnosed diffuse large B-cell lymphoma.

In an interview with&nbsp;Targeted Oncology, Eric Pujade-Lauraine, MD, PhD, discussed the data from the JAVELIN Ovarian 200 trial, which he presented at the 2019 Society of Gynecologic Oncology Annual Meeting. He highlighted the need for biomarkers in this space, as well as some data from an exploratory analysis from this trial.

A rolling submission of a New Drug Application for umbralisib has been initiated by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. The company reported in a press release that one application was considered to be acceptable for both drugs and the NDA will be completed in the first half of 2020.<br /> &nbsp;

The autologous dendric cell vaccine targeting Wilms tumor-1 antigens with or without preferentially Expressed Antigen in Melanoma was well tolerated and feasible in patients with acute myeloid leukemia, meeting the co-primary end points of the phase I/II clinical trial.