The FDA has granted Breakthrough Therapy Designation to enfortumab vedotin plus pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
In the phase II CLOVER-1 trial, the small-molecule phospholipid drug conjugate CLR 131, achieved high response rates in patients with relapsed/refractory multiple myeloma and relapsed/refractory non-Hodgkin lymphoma, meeting the primary efficacy end point of the study, according to a press release from Cellectar Biosciences, developer of the agent.
The FDA has granted Priority Review to the supplemental Biologic License Application for atezolizumab as first-line treatment of patients with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
Plinabulin in combination with docetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim led to a dose-dependent increase in mean haptoglobin and absolute neutrophil count, demonstrating potency in the stimulation of the adaptive and innate immune system following previous positive efficacy and safety results, according to data analyzed from the phase III BPI-2358-106 study presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium.
In an interview with <em>Targeted Oncology</em>, Rajneesh Nath, MD, discussed the background and rationale for the phase III SIERRA trial. He also explained what this research means for the treatment landscape of acute myeloid leukemia.
In an interview with Targeted Oncology, Martin T. King, MD, PhD,discusses INTREPId following his poster presentation of the trial design at the 2020 Genitourinary Cancer Symposium. He also discusses other another promising studies being presented at the conference.
The FDA has granted Fast Track Designation to ALX148 for the first-line treatment of patients with head and neck squamous cell carcinoma, and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma.
The FDA has granted Priority Review to the New Drug Application for lurbinectedin, which is being considered for accelerated approval as a treatment of patients with small cell lung cancer who have progressed after prior platinum-containing therapy.
The FDA has granted Priority Review to the New Drug Application for tazemetostat as treatment for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy. The drug will now be considered for accelerated approval and the application was designation as a supplemental NDA with a Prescription Drug User Fee Act target action date of June 18, 2020, Epizyme, Inc announced in a press release.
The FDA has granted Priority Review to the New Drug Application for the combination of tucatinib, trastuzumab, and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The prescription Drug User Fee Act, the FDA has set a target action date of August 20, 2020.
The FDA has granted Priority Review to the Biologics License Application for lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, after at least 2 prior therapies.
The FDA has granted Priority Review to the New Drug Application for ripretinib as treatment of patients with advanced gastrointestinal stromal tumors. This potential FDA approval has a Prescription Drug User Fee Act target action date of August 13, 2020, according to a press release from Deciphera Pharmaceuticals, Inc.<br />
First-line treatment with pembrolizumab in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients with metastatic triple-negative breast cancer who had PD-L1 expression in their tumors, meeting one of the coprimary end points of the phase III KEYNOTE-355 trial, according to the results of an interim analysis reported in a press release from Merck.
The combination of cabozantinib in combination with atezolizumab demonstrated encouraging efficacy and tolerability in patients with metastatic castration-resistant prostate cancer, according to the updated results of the phase Ib COSMIC-021 trial. The trial is evaluating the combination in locally advanced or metastatic solid tumors, Elexis, Inc, announced in a press release.
In the community practice setting, patients with hepatocellular carcinoma who receive systemic therapy have a poor prognosis, which reveals an unmet need for more effective treatment options, according to a real-world retrospective observational study. The study aimed to show how treatment patterns related to the overall survival of patients with HCC throughout the United States.
A supplemental Biologics License Application for daratumumab in combination with carfilzomib and dexamethasone was submitted to the FDA for consideration as treatment for relapsed/refractory multiple myeloma, according to a press release from Janssen Pharmaceuticals.
The FDA granted Priority Review to the New Drug Application for capmatinib, an investigational selective MET inhibitor, which will be used as treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping-mutated non–small cell lung cancer, Incyte announced in a press release.
An FDA Fast Track Designation was granted to the first-in-class radioenhancer NBTXR3 with or without cetuximab for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy, according to a press release from Nanobiotix.
Next-generation sequencing in patients with chronic lymphocytic leukemia treated with the combination of chlorambucil and ofatumumab showed that the presence of TP53, SF3B1, and NOTCH1 mutations were predictive of reduced efficacy, according to the results of the phase III COMPLEMENT1 trial published in Haematologica.
A Biologics License Application for the investigational chimeric antigen receptor T-cell therapy agent, KTE-X19, was accepted by the FDA and granted Priority Review for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, according to a press release from Kite, developer of KTE-X19.<sup> </sup>
The combination therapy of panobinostat and ruxolitinib was found to be safe and effective for the treatment of patients with primary myelofibrosis and post-polycythemia vera related myelofibrosis, and post essential thrombocythemia related myelofibrosis, according to the results of a dose-escalating, phase I trial, which was published in Leukemia Research.
The combination of ilixadencel plus sunitinib has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma, Immunicum AB announced in a press release. The research update presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium showed a survival curve separation in the phase II MERECA trial that gives promising signals for the future.
The detection of circulating tumor DNA in human papillomavirus with an experimental blood test has been associated with high positive predictive value and negative predictive value for identifying disease recurrence in HPV-positive oropharyngeal cancer, according to a press release from the University of North Carolina Lineberger Comprehensive Cancer Center.
Tremelimumab monotherapy showed clinical activity with durable responses in patients with metastatic urothelial carcinoma and documented transitional cell carcinoma of the urothelium who failed first-line platinum-based chemotherapy, according to results from a phase II study, which is evaluating the drug in solid tumors.
The majority of patients with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia who were participants in a phase I/IIa trial had clinical responses to treatment with TAK-007, a cord blood–derived chimeric antigen receptor natural killer–cell therapy that targets CD19, with no major toxicities experienced by patients, according to a press release from the University of Texas MD Anderson Cancer Center.
Performing a liquid biopsy of circulating tumor cells may help identify patients who are at risk for node-positive melanoma relapse and identify patients who wish to avoid the toxicities associated with systemic adjuvant therapy, according to the results of a prospective study from The University of Texas MD Anderson Cancer Center, which was recently published in Clinical Cancer Research.
The incidence of colorectal cancer is rising among people who are below 50 years of age, the colonoscopy screening age as recommended by the United States Preventive Service Task Force of the National Cancer Institute. To date, there is no research that can explain the rise which has led physicians to deliberation on whether the recommended screening age for colonoscopies should be lowered or left as is. During a debate at the 2020 Gastrointestinal Cancers Symposium, Uri Ladabaum, MD, and David S. Weinberg, MD, MSc, presented their stances on the topic.
In an interview with Targeted Oncology, Daniel H. Ahn, DO, discussed the phase Ib/II study of onvansertib plus FOLFIRI and bevacizumab for the treatment of patients with metastatic colorectal cancer with a KRAS mutation.
Afatinib demonstrated clinical activity against uncommon and compound <em>EGFR</em> mutations in patients with EGFR tyrosine kinase inhibitor-naive non–small cell lung cancer, a patient population for which limited data exist on the efficacy of treatment with EGFR- tyrosine kinase inhibitors, according to Yang et al.
The addition of the dinutuximab injection to irinotecan did not improve overall survival in patients with relapsed/refractory small cell lung cancer, failing to meet the primary end point of the phase III DISTINCT trial, according to top-line results announced in a press release from United Therapeutics, developer of dinutuximab.