EU’s CHMP Recommends Pembrolizumab Combo Approval in HER2+ Gastric Cancer
Findings from the phase 3 KEYNOTE-811 trial support the CHMP’s recommendation to approve pembrolizumab plus trastuzumab in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
APVO436 Combo Yields Favorable Responses in Acute Myeloid Leukemia
Data from a phase 1b dose escalation and expansion study highlight an encouraging duration of remission using APVO436 plus venetoclax and azacitidine in patients with acute myeloid leukemia.
Quizartinib May be Effective in an Older Population with FLT3-ITD+ AML
Mikkael A. Sekeres, MD, discusses how data from the phase 3 QuANTUM-First trial may advance the treatment field for patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia.
FDA Approves Quizartinib for Newly Diagnosed FLT3-ITD+ AML
Data from the phase 3 QuANTUM-First trial support the FDA’s approval of quizartinib for managing FLT3-ITD–positive acute myeloid leukemia.
Pembrolizumab Combo Yields Meaningful PFS Benefit in Cervical Cancer
The safety profile of pembrolizumab among patients with high-risk locally advanced cervical cancer in the phase 3 KEYNOTE-A18 trial appears to be consistent with previous reports of the agent.
Umbralisib Triplet May Benefit BTK-Naïve Population With R/R MCL
Umbralisib in combination with ublituximab and venetoclax appears tolerable and yields responses in a small cohort of patients with mantle cell lymphoma.
FDA Gives Fast Track Designation to ARX517 in Metastatic CRPC
The investigational antibody-drug conjugate ARX517 is currently under evaluation in patients with metastatic castration-resistant prostate cancer as part of the phase 1/2 APEX-01 trial.
Nurse Navigation Yields Non-Significant Distress Reduction in Breast Cancer
Findings from the REBECCA trial support additional research for nurse navigation intervention for managing psychological vulnerability among patients with breast cancer.
Fecal Microbiota Transplant Yields no Effect on Infection Incidence in AML
Findings from a phase 2 study may inform the design of future trials assessing fecal microbiota transplants in patients with acute myeloid leukemia.
Selinexor Receives FDA Fast Track Designation in Myelofibrosis
Selinexor plus ruxolitinib is under investigation as a treatment for JAK inhibitor-naïve patients with myelofibrosis as part of the phase 3 XPORT-MF-034 trial.
SBRT/ICI May Not Enhance Survival Outcomes in Advanced Solid Tumors
The addition of stereotactic radiotherapy to immune checkpoint inhibition appears safe but yields no significant survival benefit among patients with advanced solid tumors.
Non-Immunotherapy Interventions May Successfully Target Renal Cell Carcinoma
A better understanding of tumor biology may be necessary for identifying novel non-immunotherapy–based therapeutic strategies for patients with renal cell carcinoma, according to Rana R. McKay, MD.
Eltrombopag Reduces Bleeding, Raises Platelet Counts in Low-Risk MDS
Eltrombopag may be an effective therapy for the ‘challenging condition’ of severe thrombocytopenia in patients with low-risk myelodysplastic syndromes.
Expert Describes Direct Tumor Killing Strategies in Renal Cell Carcinoma
Probiotics and other agents targeting fatty acid oxidation are also under evaluation as treatment options for patients with renal cell carcinoma, according to Rana R. McKay, MD.
FDA Accepts NDA for Rivoceranib/Camrelizumab in Unresectable HCC
The new drug application for rivoceranib plus camrelizumab in unresectable hepatocellular carcinoma is supported by findings from the phase 3 CARES 310 study.
Black Population May Have Worse Breast Cancer Outcomes Vs White Population
Investigators report a disparity in survival among Black patients with inflammatory breast cancer, although receipt of treatment does not appear to vary according to race.
Belzutifan Generates ‘Excitement’ in Renal Cell Carcinoma, Expert Says
Other angiogenic agents are also under investigation in renal cell carcinoma, according to Rana McKay, MD, who indicates it will be interesting to see how they compare with belzutifan.
QPOLE Test May Be a Suitable Alternative to DNA Sequencing in Endometrial Cancer
The QPOLE assay may be a fast, low-cost alternative to other next-generation sequencing tools for POLE testing among patients with endometrial cancer.
Confirmatory Amivantamab NSCLC Trial Demonstrates Meaningful Benefit
Confirmatory results from the phase 3 PAPILLON study further support the FDA approval of amivantamab-vmjw for patients with locally advanced/metastatic EGFR exon 20 insertion–mutant non–small cell lung cancer.
Lenvatinib/Pembrolizumab Elicits Response in Metastatic RCC
Patients with metastatic renal cell carcinoma, and those who have been pretreated with immune checkpoint inhibitors and are naive, saw a benefit with lenvatinib plus pembrolizumab.
T-Cell and B-Cell Immune Repertoires Differences Associated With ICI Response in Metastatic RCC
Eddy Saad, MD, explained how responses to immune checkpoint inhibitors can be elicited in patients with metastatic renal cell carcinoma.
Zolbetuximab Accepted For Regulatory Review for Gastric/GEJ Cancer in Europe
The marketing authorization application for this first-in-class agent is based on data from the phase 3 SPOTLIGHT and GLOW trials; a recommendation is expected in 2024.
LOTIS-9 Trial in DLBCL Pauses Enrollment Due to Respiratory Toxicities
Investigators of the LOTIS-9 trial are assessing loncastuximab tesirine plus rituximab for the treatment of unfit or frail patients with untreated diffuse large B-cell lymphoma.
Olaparib Improves Efficacy in BAP1-mutated RCC
The phase 2 ORCHID trial met the respecified end point of Simon stage 1 design for patients with BAP1-mutated renal cell carcinoma.
Nivolumab/Chemo Extends Survival In Urothelial Carcinoma Sub-Study
The combination also demonstrates no new safety signals in patients with uresectable or metastatic disease and meets the phase 3 CheckMate-901 study’s primary survival end points.
Trastuzumab Deruxtecan Receives Chinese Approval in HER2-Low Breast Cancer
Findings from the phase 3 DESTINY-Breast04 trial supported the approval of fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer in China.
IMDC Does Not ‘Represent Accurate Biology’ in Clear Cell RCC
Better biology is needed to accurately determine risk stratification features in patients with clear cell renal cell carcinoma.
Evidenced-Based Trials Needed in Immunotherapy in Later-Line Advanced RCC
Robert J. Motzer, MD, reviews the need for increased studies on the use of immunotherapy in later-line settings for advanced renal cell carcinoma.
Neoadjuvant Immunotherapy May Help Improve Disease Control in RCC
In patients with metastatic renal cell carcinoma, neoadjuvant immunotherapy–based combinations yielded reductions in tumor size and pathologic necrosis at the time of cytoreductive nephrectomy.
A2ARs Receptor Agonist Combo May be Synergistic in Clear Cell RCC
Clear cell renal cell carcinoma is driven by a metabolic switch that decreases VHL and increases ATP, according to an expert from Vanderbilt University Medical Center.
