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SC Pembrolizumab Noninferior to IV in NSCLC: Phase 3 Trial Results
Enriqueta Felip, MD, PhD, discusses the 3475A-D77 trial of subcutaneous pembrolizumab vs intravenous pembrolizumab plus chemotherapy in metastatic NSCLC.
The Targeted Pulse: FDA Approvals in HCC and CRC, Promise for SCLC, and More
The week marked several FDA approvals for drugs and devices, plus data continues to show tarlatamab’s benefit in small cell lung cancer.
Clinical Evaluation of TMLI and PTCy in MRD-Negative AML Transplant
Anthony S. Stein, MD, discusses a study of total marrow and lymphoid irradiation 20 Gy and post-transplant cyclophosphamide in acute myeloid leukemia undergoing allogeneic hematopoietic cell transplantation.
Leighl Covers PALOMA-3 Trial of SC Amivantamab in NSCLC
Natasha Leighl, MD, MMSc, BSc, discussed key findings from the PALOMA-3 trial for a community oncologist audience.
AI Tool Earns FDA Breakthrough Device Designation in Pancreatic Cancer
The DAMO PANDA can accurately detect pancreatic cancer lesions, and FDA breakthrough therapy designation aims to accelerate its development and approval.
Bria-IMT Plus Retifanlimab Shows Promising Survival in HR+ Breast Cancer
Phase 2 data suggest a survival benefit with Bria-IMT and retifanlimab in heavily pretreated HR-positive metastatic breast cancer, outperforming historical controls.
Bexmarilimab Shows Promise in Tough-to-Treat HR MDS; Phase 3 Planned
Bexmarilimab and azacitidine showed continued tolerability and a high overall response rate in relapsed/refractory higher-risk myelodysplastic syndromes in a phase 2 study.
FDA Clears IND Application for CLD-201 in Solid Tumors
The FDA has granted clearance to an investigational new drug application for CLD-201 for solid tumor treatment, based on preclinical findings.
Italian Study Highlights Real-World Data for Melphalan Flufenamide in Myeloma
Melphalan flufenamide (melflufen) is approved in Europe for relapsed/refractory multiple myeloma, but the FDA withdrew its approval of the treatment last year.
Lenvatinib as a Key First-Line Therapy in RAI-Refractory DTC
Francis P. Worden, MD, discusses his key takeaways for other oncologists treating patients with radioidine-refractory differentiated thyroid cancer.
Analysis Illuminates CAR T-Cell Optimization for CLL
Fewer prior therapies with liso-cel in chronic lymphocytic leukemia showed improved overall response rate in TRANSCEND-CLL-004 analysis.
Well-Tolerated TLX101 Shows Efficacy in Recurrent Glioma
Preliminary results from the phase 2 IPAX-Linz study show encouraging efficacy and a favorable safety profile for TLX101 in recurrent high-grade glioma.
FDA Grants Novel Therapy RMAT Designation for Dysphagia Following Head and Neck Cancer Treatment
The FDA granted regenerative medicine advanced therapy designation to iltamciocel for patients with oropharyngeal dysphagia following head and neck cancer treatment.
New Phase in Prostate Cancer Fight: Cu-SAR-bisPSMA Trial Begins
The first patient in a phase 2 clinical trial evaluating 67Cu-SAR-bisPSMA for patients with metastatic castration-resistant prostate cancer has been dosed.
Immunotherapy Inches Forward in Head and Neck Cancer Trials
The precise use of immunotherapy agents in locally advanced head and neck squamous cell carcinoma has not been clearly delineated, even in phase 3 trials.
Auletta Delves Into the ACCESS Trial and GVHD Prevention
Jeff Auletta, MD, discusses the background, methods, design and findings from the ACCESS trial.
Nivolumab Plus Ipilimumab Trends Toward Prolonged OS in nccRCC
Nivolumab plus ipilimumab showed a strong median overall survival (OS) advantage at 12 months and a trend toward overall prolonged OS vs SOC in non-clear cell renal cell carcinoma.
FDA to Review Nogapendekin Alfa in Bladder Cancer and Lymphopenia
A supplemental biologics license application has been submitted to the FDA for nogapendekin alfa plus Bacillus Calmette-Guérin in papillary non-muscle invasive bladder cancer.
Predicting Palbociclib Outcomes in Breast Cancer Using Deep Learning
Xiaojie Zhang, MD, and Akshat Singhal, PhD, discuss their research leveraging deep learning to predict how patients with ER+/HER2- breast cancer will respond to palbociclib.
AI May Replace the Front Desk in Health Care
AI is no longer in the realm of speculative science fiction—it’s here, and it’s moving fast.
Real-World Bispecific Antibody Use Post-CAR T in DLBCL
Geoffrey Shouse, DO, PhD, discusses what motivated this retrospective review of bispecific antibodies in diffuse large B-cell lymphoma at City of Hope.
Novel Radioenhancer JNJ-1900 Shows Potential Across Cancers
Jared Weiss, MD, discussed the mechanism of action of JNJ-1900 and the preliminary data presented at the 2025 European Lung Cancer Congress.
Behind the Phase 3 3475A-D77 Trial of SC Pembrolizumab in NSCLC
Enriqueta Felip, MD, PhD, discusses the design of the phase 3 3475A-D77 trial evaluating subcutaneous pembrolizumab in metastatic NSCLC.
Savolitinib/Osimertinib Yields Durable Responses in EGFR-Mutated, MET+ NSCLC
The phase 2 SAVANNAH trial of savolitinib plus osimertinib has demonstrated the combination’s efficacy and safety in EGFR-mutated NSCLC.
SGX301 Shows Rapid and Durable Responses in Early-Stage CTCL
SGX301 has shown rapid and sustained benefit in early cutaneous T-cell lymphoma in an investigator-initiated study, with good safety.
FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
Following a recent Type D meeting with the FDA, a phase 3 clinical trial design for darovasertib in primary uveal melanoma has been announced.
Promising Trials Expand Approaches Across Multiple Myeloma Settings
John M. Burke, MD, highlights findings from the AQUILA, DREAMM 7, and MajesTEC-5 trials in multiple myeloma.
Neoadjuvant Nivolumab/Chemo Shows Promise in HPV-Negative HNSCC
Neoadjuvant nivolumab/chemotherapy followed by response-stratified de-escalated chemoradiation showed strong potential in HPV-negative head and neck cancer.
The Targeted Pulse: SC Pembrolizumab Combo Matches SOC in NSCLC and CAR T-cells Transform the Solid Tumor Space
Chemotherapy/Pembrolizumab SC shows noninferior to SOC in NSCLC, expert insights on advances with CAR T-cells, and a full approval for gastric cancer.
Ferreyros on Biomarker Access and Physician Autonomy in Community Oncology
Nicolas Ferreyros discusses the Community Oncology Alliance’s position statements on biomarker testing and physician autonomy.
