Nivolumab/Cisplatin/Radiotherapy Improves DFS in Locally Advanced SCCHN
The phase 3 NIVOPOSTOP GORTEC 2018-01 trial shows that nivolumab added to radiotherapy and cisplatin had improved efficacy over SOC treatments in SCCHN.
FDA Gives Fast Track Designation to VGT-309 for Lung Tumor Visualization
Efficacy findings from a phase 2 trial demonstrated that abenacianine visualized lung tumor tissue and was well tolerated when used during surgery.
Novel Drug Receives FDA Breakthrough Therapy Designation for R/R Osteosarcoma
GSK5764227 yielded promising antitumor efficacy while showing no new safety signals in patients with relapsed/refractory osteosarcoma, the phase 2 ARTEMIS-002 trial found.
IMM-1-104 Regimens Yield Promising Activity in Pancreatic Cancer
Investigators of a phase 2a trial plan to include additional combination arms assessing treatment with IMM-1-104 across different patient populations.
Amivantamab/Lazertinib Show OS Improvement for mNSCLC Over Osimertinib
Results from the phase 3 MARIPOSA trial found that amivantamab plus lazertinib met the final pre-specified secondary end point of overall survival in NSCLC.
Early-Onset Colorectal Cancer Incidence Has Risen on Global Scale
Data suggest a need for international preventive strategies and educational efforts regarding the increasing incidence of early-onset colorectal cancer.
FDA Issues Guidance Considerations for Tissue Biopsies in Clinical Trials
According to the FDA, biopsies should be optional in clinical protocol when information will be used to evaluate only non-key secondary end points.
FDA Grants Orphan Drug Designation to Amezalpat in Hepatocellular Carcinoma
Data from a phase 1b/2 trial show improvements in overall survival with amezalpat plus atezolizumab/bevacizumab among patients with metastatic HCC.
FDA Grants Priority Review to Sunvozertinib for EGFR exon20 NSCLC
The WU-KONG1 trial found that sunvozertinib yielded a best ORR of 53.3% and a cORR of 44.9% in patients with NSCLC harboring EGFR exon20ins mutations.
Novel HER2 TKI Shows Preliminary Activity in Breast Cancer Brain Metastases
Phase 1 data may support further development of ZN-1041 combination therapies for a larger breast cancer population.
Nivolumab/Ipilimumab Continues to Show Survival Benefit in Melanoma
The CheckMate 067 trial found that, at a 10-year follow-up, nivolumab/ipilimumab elicited a median OS of 71.9 months in patients with previously untreated, advanced melanoma.
Upamostat Combo Demonstrates Tolerability in Metastatic Pancreatic Cancer
No dose-limiting toxicities were observed with upamostat combination therapy in patients with metastatic pancreatic cancer.
Pandemic Cancer Incidence Observance Shows Further Recovery Still Needed
A study observed differences between expected and observed cancer incidence in 2020 and 2021 to evaluate the pandemic’s disruption of cancer detection.
Savolitinib Combo Earns Priority Review in China for EGFR+ NSCLC
Findings from the phase 3 SACHI trial support the National Medical Products Administration’s priority review designation for savolitinib/osimertinib.
Using Multidisciplinary Lifestyle Medicine to Enhance Cancer Survivor QOL
Authors of an article published in ONCOLOGY® detail how a novel multidisciplinary lifestyle medicine clinic can meet the needs of cancer survivors.
SBRT/Concurrent Chemoradiotherapy Shows Favorable Activity in NSCLC
Although not hitting its primary end point, a phase 2 trial showed that SBRT plus concurrent radiotherapy improved on results elicited in other trials.
Taletrectinib Gains Chinese Approval for Advanced ROS1-Positive NSCLC
The decision is supported by results from the phase 2 TRUST-1 trial, which evaluated the safety and efficacy of taletrectinib in ROS1-positive NSCLC.
Atezolizumab Combo Results Shows Promising Option in EGFR-Mutated NSCLC
Atezolizumab combination therapy elicited better responses in patients with PD-L1 expression of 1% or more with EGFR-mutant NSCLC.
Gemcitabine Combo May Prolong Survival in Pancreatic Adenocarcinoma
Gemcitabine plus capecitabine was found to elicit longer survival outcomes than capecitabine alone in patients with pancreatic adenocarcinoma.
Real-World Data Shows Improved Responses for Pembrolizumab/Chemo in TNBC
A study of patients who received the KEYNOTE-522 regimen showed an improved pathologic complete response in real-world data vs what study data showed.
Zanabrutinib Remains Favorable Over Bendamustine/Rituximab in CLL/SLL
At a median follow-up of 61.2 months, zanabrutinib demonstrated superior PFS vs bendamustine and rituximab in patients with CLL and SLL.
Developer Submits BLA for TLX250-CDx Kidney Cancer Imaging in ccRCC
TLX250-CDx elicited a mean sensitivity of 85.5% and a mean specificity of 87.0% in patients with indeterminate renal masses in the phase 3 ZIRCON trial.
Satri-cel Improves PFS in CLDN18.2+ Advanced Gastric/GEJ Cancers
Treatment with satricabtagene autoleucel met the primary end point of progression-free survival in the phase 2 CT041-ST-01 trial.
Psilocybin May Elicit Positive Personality Changes in Cancer Populations
A pooled analysis of 2 trials show that psilocybin-assisted psychotherapy may provide mental health benefits for patients with cancer.
Datopotamab Deruxtecan EU Application Is Voluntarily Withdrawn for NSCLC
Feedback from the European Medicines Agency following results of the phase 3 TROPION-Lung01 informed the marketing authorization application withdrawal.
FDA Receives NDA for Dordaviprone in Recurrent H3 K27M+ Glioma
Developers have requested priority review status for dordaviprone as a treatment for patients with recurrent H3 K27M-mutated glioma.
Avutometinib With Defactinib Accepted for Review by FDA in Recurrent LGSOC
Avutometinib/defactinib was granted priority review by the FDA in the treatment of patients with recurrent, KRAS-mutant low-grade serous ovarian cancer.
Pembrolizumab Added to Preoperative Radiotherapy and Surgery Enhances DFS in Sarcoma
The SU2C-SARC032 study evaluating pembrolizumab plus radiotherapy and surgery found the regimen was well tolerated with infrequent surgical complications.
CAR T-Cell Therapy Debate in Leukemia/Lymphoma Subtypes
A Satellite Sessions event that took place at Fred Hutchinson Cancer Center and discussed treatments surrounding LCL and CLL.
Nivolumab/Ipilimumab Combo Elicits Further PFS Benefit in Frontline MSI-H/dMMR mCRC
Updated efficacy findings from the phase 3 CheckMate-8HW trial also showed fewer grade 3/4 adverse events with nivolumab/ipilimumab vs chemotherapy.
