News

Despite evidence from previous studies that showed that platinum-based chemotherapy agents are active in patients with breast cancer, platinum-based chemotherapy was not found to be superior to standard chemotherapy in terms of eliciting pathologic complete responses in patients with HER2-negative breast cancer carrying a BRCA mutation, according to data from the INFORM trial published in the Journal of Clinical Oncology.

According to results from the phase III DANUBE bladder cancer trial, neither of the co-primary end points of the trial were met. The combination of durvalumab, and tremelimumab did not show an improvement in overall survival in treatment-naïve patients with unresectable, stage IV bladder cancer. Also, durvalumab alone failed to show an OS benefit over standard-of-care chemotherapy alone in patients with high PD-L1 expression.

The FDA granted Orphan Drug Designation to umbralisib, an investigational oral PI3K delta inhibitor as treatment for patients with follicular lymphoma, according to a press release from TG Therapeutics. This designation follows a New Drug Application for treatment of marginal zone lymphoma and follicular lymphoma, which was submitted to the FDA in October 2019, based on results from the phase IIb UNITY-NHL study.

In an interview with Targeted Oncology, Augusto Villanueva, MD, discussed the role of driver mutations in patients with HCC and how liquid biopsies may help improve the treatment landscape in this patient population.

The combination of fulvestrant and capivasertib prolonged progression-free survival compared with placebo in patients with estrogen receptor-positive breast cancer who were previously treated with aromatase inhibition, according to results from the phase II FAKTION trial, published in The Lancet Oncology.

Changes in the tumor microenvironment following progression on EGFR tyrosine kinase inhibitor therapy suggest a potential for benefit from PD-1/PD-L1 inhibitors in patients with EGFR-positive non–small cell lung cancer, according to the results of a retrospective study published in Clinical Cancer Research.

In an interview with Targeted Oncology, Alexey V. Danilov, MD, PhD, discussed the ELEVATE-TN trial and other potentially practice-changing BTK inhibitor combinations expected to emerge in chronic lymphocytic leukemia.

In an interview with Targeted Oncology, Alexandra S. Bercow, MD, discussed the results from a retrospective study, which evaluated the role of palliative care in women who died from cervical cancer between 2000 and 2017 at 2 institutions. She also highlighted the benefit of palliative care and why this patient population could benefit more than those with ovarian or endometrial cancers.

In an interview with Targeted Oncology, Shilpa Gupta, MD, discussed the results of the BLASST-1 trial evaluating neoadjuvant nivolumab plus gemcitabine and cisplatin in patients with muscle-invasive bladder cancer undergoing a cystectomy. She highlighted the next steps and key points community oncologists need to know about these data now.

In an interview with Targeted Oncology, Van K. Morris, MD, discussed a pooled analysis of the TRIBE trials to determine how oligometastatic disease status impacts treatment decisions. He also discussed advances in the field, including novel treatments that are emerging for advanced CRC.

The FDA has granted Breakthrough Device designation to GALAD score, a serum biomarker-based device that predicts the probability that patients with chronic liver disease will develop hepatocellular carcinoma.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

Both autologous stem cell transplant and allogeneic stem cell transplant can be used as consolidation therapy in patients with mantle cell lymphoma, according to results from a single-center analysis, presented in a poster at the 2020 Transplantation & Cellular Therapy Meetings. However, the benefit of alloSCT is offset by an increased risk of transplant-related mortality and the development of graft-versus-host-disease.

According to findings from a retrospective analysis published in JAMA Oncology, the testosterone-related genetic variant HSD3B1 (1245C) is associated with more aggressive disease in patients with metastatic prostate cancer. This is the first clinical trial to validate the relationship between the variant and clinical outcomes, and the results may help physicians determine which patients are more likely to benefit from more aggressive therapy.

The FDA has granted a fast track designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas, according to a press release from Kura Oncology, Inc. The fast track designation includes patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with a T follicular helper phenotype.

The FDA has granted Fast Track Designation to AL101, an injectable small molecule gamma secretase inhibitor, as treatment of patients with recurrent or metastatic adenoid cystic carcinoma. The designation follows an Orphan Drug Designation granted in May of 2019 for treatment of ACC, Ayala Pharmaceuticals, Inc. announced in a press release.

The triplet combination of selinexor, bortezomib, and dexamethasone demonstrated an improved median progression-free survival rate over the standard regimen of bortezomib and dexamethasone in treating patients with multiple myeloma in the BOSTON trial

The combination of venetoclax plus low-dose cytarabine did not demonstrate a statistically significant improvement in overall survival compared with LDAC plus placebo in patients with acute myeloid leukemia who were ineligible for intensive chemotherapy at the time of a planned analysis, missing the primary end point of the phase III VIALE-C trial.

The FDA has approved the combination of isatuximab-irfc with pomalidomide and dexamethasone as treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Treatment with pembrolizumab resulted in a statistically and clinically significant improvement in progression-free survival compared with brentuximab vedotin in adults patients with relapsed or refractory classical Hodgkin lymphoma , meeting a dual primary end point of the phase III KEYNOTE-204 trial, according to the interim analysis results announced in press release from Merck.

The FDA has granted Priority Review to the newly accepted Biologics License Application for tafasitamab and lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The Prescription Drug User Fee Act target action date was set as August 30, 2020, with no plans for an advisory committee meeting to discuss the application.

Cemiplimab is an active treatment option for locally advanced cutaneous squamous cell carcinoma and has an acceptable safety profile, according to the results of an international phase II open-label study published recently in Lancet Oncology.

Patients with metastatic renal cell carcinoma in a real-world cohort of a retrospective analysis demonstrated positive activity and a favorable safety profile when receiving frontline tivozanib.

High volumes of mutations observed through liquid biopsies may be associated with an improvement in progression-free survival  and clinical benefit after first-line standard-of-care pembrolizumab-based therapy in patients with metastatic non-small cell lung cancer, according to findings from a prospective biomarker trial conducted by investigators at the University of Pennsylvania Perelman School of Medicine and Abramson Cancer Center, which were published in Clinical Cancer Research.

Data from 3 phase I/II clinical trials confirm that larotrectinib is a highly active agent for the treatment of TRK fusion-positive advanced solid tumors and is feasible for long-term use, according to a pooled analysis recently published in The Lancet Oncology.

In an interview with Targeted Oncology, Zofia Piotrowska, MD, MHS, discussed the role of EGFR inhibition as frontline treatment of patients with EGFR-mutant lung cancers, as well as the combinations with osimertinib that are currently underway and appearing promising for this treatment landscape.

The FDA has granted Breakthrough Therapy Designation for Debio 1143, an inhibitor of apoptosis proteins, for the treatment of patients with a confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin-based concomitant standard fractionation chemoradiation, the current standard of care, announced Debiopharm in a press release.<br /> &nbsp;

The FDA Oncologic Drugs Advisory Committee agreed that ramucirumab plus erlotinib showed a favorable benefit/risk profile in patients with untreated metastatic EGFR-positive non&ndash;small cell lung cancer in the phase III RELAY study. The vote was 6 to 5 in favor of the combination and ODAC has scheduled a hearing to discuss the terms of the Biologic License Application.<br /> &nbsp;

The FDA has approved a supplemental New Drug Application for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have previously received 2 or more anti&ndash;HER2-based regimens in the metastatic setting, according to a press release issued by the manufacturer Puma Biotechnology, Inc.

Updated results from the phase II arm of the DeCidE1 trial of DPX-Survivac demonstrated promising activity and tolerability in patients with heavily pretreated, advanced recurrent ovarian cancer, according to the developer of the agent IMV Inc.