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Priority Review Granted to Pembrolizumab Combo in Metastatic Esophageal and GEJ Cancer
December 17th 2020The FDA granted a Priority Review designation to pembrolizumab for potential approval with platinum and fluoropyrimidine-based chemotherapy as frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction.
Pembrolizumab Plus Lenvatinib Significantly Improves Survival in Advanced Endometrial Cancer
December 17th 2020Pembrolizumab plus lenvatinib induced a statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate compared with chemotherapy in patients with advanced endometrial cancer after prior systemic therapy in the phase 3 KEYNOTE-775/Study 309 trial.
Neratinib Plus Capecitabine Improved PFS in Patients With HER2+ Breast Cancer With Brain Mets
December 15th 2020Neratinib in combination with capecitabine induced a 34% reduction in the risk of disease progression or death as treatment of patients with HER2-positive breast cancer who had central nervous system metastases at baseline compared with lapatinib and capecitabine.
ctDNA Biomarker for Responses, Outcomes Observed for High-Risk Patients With Early Breast Cancer
December 15th 2020Following neoadjuvant chemotherapy with or without pembrolizumab in patients with high-risk early-stage breast cancer, the presence of ctDNA was a biomarker for response and distant recurrence-free survival.
Updated Findings Show Continued Efficacy for CAR T-Cell Therapy in Heavily Pretreated Myeloma
December 14th 2020In an interview with Targeted Oncology, Yi Lin, MD, PhD discussed the updated findings from the CRB-401 study of idecabtagene vicleucel as treatment of patients with relapsed/refractory multiple myeloma.
FDA Grants Emergency Use Authorization to First Vaccine for COVID-19 Prevention
December 14th 2020The FDA granted the first Emergency Use Authorization to the vaccine, BNT162b2, for the prevention of COVID-19, which allows for the vaccine to be distributed in the United States for individuals who are at least 16 years or older.
Phase 3 LAURA Study to Explore Efficacy of Maintenance Osimertinib in Stage III EGFR-Mutant NSCLC
December 14th 2020The phase 3 LAURA clinical trial is currently enrolling patients with stage III, unresectable EGFR-mutant non–small cell lung cancer to explore the efficacy and safety of the third-generation tyrosine kinase inhibitor osimertinib as maintenance therapy following chemoradiation.
Practice Gaps for Immunotherapy Identified in Community Oncology Centers
December 14th 2020Only 61% of patients completed therapy fully with checkpoint inhibition as planned, while treatment was delayed or discontinued in 22% due to immune-related adverse events, according to findings from a quality improvement research study conducted by the Association of Community Cancer Centers.
Exploring Increase of Point Mutations Associated with High-Dose Melphalan in Multiple Myeloma
December 14th 2020In an interview with Targeted Oncology, Mehmet Samur, PhD, discussed the investigation of high-dose melphalan following autologous stem cell transplant in patients with multiple myeloma and shared insights into how the ongoing questions can be explored in the future.
Tucatinib Combo Lengthens Time to Deterioration of HRQoL in HER2+ mBC With Brain Mets
December 12th 2020Patients with HER2-positive metastatic breast cancer and brain metastases treated with the combination of tucatinib, trastuzumab, and capecitabine had significantly lengthened the time to deterioration of health-related quality of life, according to the results of an analysis of the HER2CLIMB clinical trial presented during the 2020 San Antonio Breast Cancer Symposium.
CAR T Cells Inching Toward FDA Approval in Heavily Pretreated Multiple Myeloma
December 12th 2020In an interview with Targeted Oncology, Jesus G. Berdeja, MD, discussed a subanalysis of the KarMMA study and updated results from CARTITUDE-1, which provide insights on the use CAR T-cell therapy in heavily pretreated patients with multiple myeloma, including the elderly and frail.
Atezolizumab More Likely to Benefit Urothelial Cancer With Detectable ctDNA
December 12th 2020Adjuvant atezolizumab in patients with high-risk muscle-invasive urothelial cancer with detectable circulating tumor DNA demonstrated more benefit compared with those with MIUC and undetectable ctDNA, according to data from the IMvigor010 trial.
Broad Spectrum of Upfront Therapies Available for Follicular Lymphoma
December 10th 2020In an interview with Targeted Oncology, John M. Burke, MD, discussed the current treatment paradigm for patients with follicular lymphoma and reviewed the factors he considers when making treatment decisions for this population.
Elderly Patients With HER2+ Advanced Breast Cancer Experience Poorer Outcomes, Increased Toxicity
December 9th 2020Despite having similar disease characteristics and treatment patterns, elderly patients with HER2-positive advanced breast cancer aged ≥ 70 years experienced shorter chemotherapy durations than patients under the age of 70, as well as, poorer overall survival, and increased rates of adverse events in a real-world study.
FDA Grants Sotorasib Breakthrough Therapy Designation for Advanced KRAS G12C-Mutant NSCLC
December 8th 2020The FDA granted a Breakthrough Therapy designation to sotorasib for the treatment of patients with locally advanced or metastatic non–small cell lung cancer who harbored a KRAS G12C mutation following at least 1 prior line of systemic therapy.
Mosunetuzumab Elicits High and Durable Responses in Subgroups of Patients With FL
December 8th 2020A phase clinical trial has demonstrated that administering a mosunetuzumab fixed-duration leads to high, durable, and consistent responses in patients with follicular lymphoma across multiple subgroups. Data from the study were presented during the virtual 2020 American Society of Hematology Annual Meeting.
FDA Halts Phase 1/2 CAR T-Cell Study in Pancreatic and Prostate Cancer
December 8th 2020The phase 1/2 study of the investigational chimeric antigen receptor T-cell agent BPX-601 administered as treatment of patients with previously treated metastatic pancreatic or prostate cancer is no longer active after the FDA place a partial clinical hold on the trial.
Activity of Brentuximab Vedotin Plus Nivolumab Clinically Meaningful for Subset of Patients with HL
December 7th 2020The combination of brentuximab vedotin and nivolumab demonstrated activity in patients with previously untreated Hodgkin lymphoma who had comorbidities in a phase 2 clinical trial, despite the trial not meeting its prespecified criteria for activity.
Bispecific Anti-CD20, Anti-CD19 CAR T Cells Inspire Hope for CAR-Naïve NHL in Phase 1
December 7th 2020In an interview with Targeted Oncology, Nirav N. Shah, MD, discussed the findings from the phase 1 study of a CAR T-cell therapy dual targeting CD19 and CD20 as treatment of patients with B-cell lymphomas.
First-In-Human Trial Shows Responses With Off-the-Shelf CAR T-Cell Therapy in Myeloma
December 5th 2020The off-the-shelf CAR T-cell therapy ALLO-715, which targets BCMA, demonstrated responses as treatment of patients with heavily pretreated relapsed/refractory multiple myeloma in a first-in-human clinical trial.
ROR1-Directed ADC Generates Clinical Activity in First-In-Human Study of MCL and DLBCL
December 5th 2020The novel ROR1-targeted antibody-drug conjugate VLS-101 induced encouraging clinical efficacy, consistent pharmacokinetics, and a favorable safety profile as treatment of heavily pretreated patients with mantle cell lymphoma and diffuse large B-cell lymphoma.
Navitoclax Plus Ruxolitinib Improves Spleen Volume, Symptoms in R/R Myelofibrosis
December 5th 2020Improvements in spleen volume and total symptom score were clinically meaningful with the addition of navitoclax to ruxolitinib in patients with myelofibrosis who no longer benefited from prior ruxolitinib therapy.