Jordyn Sava is an assistant editor for Targeted Oncology.
FDA Grants Orphan Drug Designation to ABM-1310 for Glioblastoma
ABM-1310 is a novel small molecule BRAF inhibitor that has shown promising anti-cancer activity and a good safety profile across a variety of advanced BRAF V600-mutant solid tumors.
FDA Approves Trifluridine/Tipiracil Plus Bevacizumab in mCRC
Trifluridine/tipiracil plus bevacizumab improved rates of progression-free and overall survival vs trifluridine/tipiracil alone in the SUNLIGHT study. Now, the combination is FDA-approved for patients with metastatic colorectal cancer.
Study of SYNCAR-001 and STK-009 Begins in CD19+ Hematologic Malignancies
The phase 1 study is evaluating the combination of a CD19-targeting chimeric antigen receptor and an orthogonal IL-2 in patients with CD19-positive hematologic malignancies.
FDA Green Lights ODD for Elraglusib in Pancreatic Cancer
A promising disease control rate and overall response rate was seen with elraglusib when given with chemotherapy for patients with pancreatic cancer, according to phase 2 study findings.
Niraparib Maintenance Improves Survival in BRCA Wild-Type Ovarian Cancer
In an interview with Targeted Oncology, Robert L. Coleman, MD, FACOG, FACS, discussed real-world findings from a trial evaluating second-line maintenance niraparib in patients with recurrent ovarian cancer.
FDA Grants Fast Track Designation to IVS-3001 for RCC
IVS-3001, a chimeric antigen receptor therapy developed to target and kill HLA-G-bearing cells, is currently in late-stage preclinical development for the treatment of solid tumors.
KEYNOTE-756 of Pembrolizumab/Chemotherapy Improves pCR in ER+HER2- Breast Cancer
KEYNOTE-756 is the first positive phase 3 study to generate a statistically significant improvement in pathological complete response rate with an immunotherapy regimen in the neoadjuvant setting for ER-positive/HER2-negative breast cancer.
FDA Issues Complete Response Letter to BLA of Denileukin Diftitox for CTCL
Although no safety or efficacy issues were reported in the biologics license application for denileukin diftitox for cutaneous T-cell lymphoma, a complete response letter has been issued.
Quizartinib Improves OS in FLT3-ITD+ AML
The phase 3 QuANTUM-First trial showed that quizartinib plus chemotherapy with or without allogeneic hematopoietic stem cell transplant improved overall survival in patients with acute myeloid leukemia with a FLT3-ITD mutation.
VOYAGER Trial Shows Potential of ctDNA Analysis in GIST
ctDNA sequencing can efficiently detect KIT/PDGFRA mutations and predict outcomes in patients with tyrosine kinase inhibitor-resistant gastrointestinal stromal tumor treated with avapritinib.
UGN-102 Meets Primary End Points in Phase 3 Trials of LG-IR-NMIBC
Topline data from the phase 3 ATLAS and ENVISION trials of UGN-102 showed a robust and consistent therapeutic profile when used for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer.
NCCN Guidelines Add Flotufolastat F 18 Injection for Prostate Cancer
Data from 2 studies, LIGHTHOUSE and SPOTLIGHT, have shown the benefit of flotufolastat F 18 injection as a radiohybrid PSMA-targeted pet imaging agent in prostate cancer. The agent has now been added to the NCCN guidelines.
Trastuzumab Deruxtecan Provides Clinical Benefit in Metastatic Gastric/GEJ Cancer
According to data from the primary and updated analyses of the phase 2 DESTINY-Gastric02 study, trastuzumab deruxtecan is beneficial for patients with HER2-positive advanced gastric cancer.
Maintenance Therapy With Niraparib Prolongs PFS in Ovarian Cancer
Niraparib as a monotherapy is supported as standard of care for a broad patient population with advanced ovarian cancer after first-line platinum-based chemotherapy.
LOTIS-9 Study of Lonca R in Previously Untreated DLBCL Discontinues
Investigators do not believe the benefit-risk profile of Lonca R in previously untreated diffuse large B-cell lymphoma supports continuation of the LOTIS-9 trial.
XPORT-EC-042 Studies Selinexor Maintenance in TP53WT Endometrial Cancer
Investigators are evaluating the efficacy and safety of selinexor vs placebo when used as a maintenance therapy for patients with p53 wild-type advanced or recurrent endometrial cancer.
Rivoceranib/Camrelizumab is Effective in the First-Line for uHCC
Significant progression-free survival and overall survival benefits were demonstrated with rivoceranib plus camrelizumab for patients with unresectable hepatocellular carcinoma when used in the first-line setting.
Analysis Supports Consolidative Stem Cell Transplant for CD30+ PTCL Post A+CHP
Though the benefit of consolidative stem cell transplant for patients who received A+CHP appeared less pronounced vs those treated with the CHOP regimen, the method is still supported for patients with CD30-positive peripheral T-cell lymphomas.
Changes to the SCLC Treatment Landscape Stirs Up Hope for Oncologists
In an interview with Targeted Oncology, Sagun Shrestha, MD, evaluated new developments and clinical trials for patients with extensive-stage small cell lung cancer.
BOND-003 Study of Cretostimogene Grenadenorepvec in NMIBC Completes Enrollment
A total of 110 patients with Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer have been enrolled in a phase 3 study evaluating cretostimogene grenadenorepvec.
PANOVA-3 Trial Should Continue to Assess TTFields in Pancreatic Cancer
Interim analysis results of the phase 3 PANOVA-3 trial in patients with unresectable, locally advanced pancreatic cancer support the company proceeds with the final analysis
FDA Approves Quizartinib Plus Chemotherapy for Newly-Diagnosed FLT3-ITD+ AML
Data from the phase 3 QuANTUM-First trial have led the FDA to approve quizartinib with or without standard chemotherapy for the treatment. of FLT3-ITD-mutant acute myeloid leukemia .
Adding Perioperative Chemo to Surgery Improves Survival in Sarcomatoid UC
In an interview, Rohan Garje, MD, discussed his research on comparing the outcomes of sarcomatoid and classic urothelial carcinoma of bladder.
APVO436 Triplet Shows Promise in Treatment-Naïve AML
New duration of remission data add to a growing body of clinical evidence supporting the development of APVO436 in combination therapy for patients with acute myeloid leukemia.
FDA Grants Fast Track Designation to ARX517 for mCRPC
Initial data from the phase 1/2 APEX-01 trial support the FDA’s fast track designation for ARX517 in patients with metastatic castration-resistant prostate cancer.
Sarcoma Awareness Month: Impact of Molecular Testing and Individualized Treatments
For Sarcoma Awareness Month, Lisa B. Ercolano, MD, and Mark Agulnik, MD, discussed the importance of understanding the genomics of sarcomas and how molecular testing can be useful in this space.
Early Data Shows Potential of Surgically Targeted Radiation Therapy in GBM
In an interview with Targeted Oncology, Ahmad Ozair, MBBS, discussed treatments for glioblastoma and a trial evaluating surgically targeted radiation therapy in this patient population.
Phase 1/2 Study of THE-630 Terminates Enrollment of Patients With GIST
THE-630 will no longer be developed for patients with GIST after patients treated at the 27 mg dose experienced dose-limiting toxicities.
Mature Data From KEYNOTE-826 Study of Pembrolizumab Addition in Cervical Cancer
Bradley J. Monk, MD, FACS, FACOG, discusses findings from the phase 3 KEYNOTE-826 trial of the addition of pembrolizumab to chemotherapy for patients with persistent, recurrent, or metastatic cervical cancer.
FDA Accepts NDA for Rivoceranib Plus Camrelizumab in Unresectable HCC
The acceptance of a new drug application for rivoceranib plus camrelizumab by the FDA is supported by data from the phase 3 CARES 310 study in patients with unresectable hepatocellular carcinoma.
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