Latest Updates From OncoNexus

HERIZON-GEA-01: Zanidatamab Plus Chemotherapy ± Tislelizumab Advances First-Line Treatment in HER2-Positive Gastroesophageal Adenocarcinoma

HERIZON-GEA-01 is a pivotal phase III trial evaluating zanidatamab-based regimens, with or without the PD-1 inhibitor tislelizumab, compared with trastuzumab...
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Dr. Katie S. Murray, DO on Evolving Treatment Strategies for NMIBC

Dr. Katie Murray discusses the diagnosis and management of non–muscle invasive bladder cancer, emphasizing cystoscopy and initial TURBT as the...

Maintenance Therapy Intensification with Palbociclib Improves PFS in HR-Positive, HER2-Positive Metastatic Breast Cancer

In the phase 3 PATINA trial, adding the CDK4/6 inhibitor palbociclib to maintenance HER2-targeted and endocrine therapy significantly prolonged progression-free...
FDA Approval

FDA Approves Trastuzumab Deruxtecan (T-DXd) Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

The FDA has approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab for first-line treatment of unresectable or metastatic HER2-positive breast cancer....

ZIRCON-X: TLX250-CDx PET/CT Changes Management in Indeterminate Renal Masses

Indeterminate renal masses (IRMs) are a common diagnostic challenge, often leading to invasive biopsies, unnecessary surgery, or prolonged surveillance due...

Phase III COMMIT Study Shows Promising Frontline Approach for dMMR/MSI-H Metastatic Colorectal Cancer

The phase III COMMIT trial demonstrates that intensifying first-line immunotherapy with chemotherapy and antiangiogenic therapy can substantially improve outcomes for...

Latest Updates in Genitourinary Oncology

murray_thumbnail_evolving_treatments_strategies

Dr. Katie S. Murray, DO on Evolving Treatment Strategies for NMIBC

Dr. Katie Murray discusses the diagnosis and management of non–muscle invasive bladder cancer, emphasizing cystoscopy and initial TURBT as the...

ZIRCON-X: TLX250-CDx PET/CT Changes Management in Indeterminate Renal Masses

Indeterminate renal masses (IRMs) are a common diagnostic challenge, often leading to invasive biopsies, unnecessary surgery, or prolonged surveillance due...

Targeting HIF‑2α and VEGF in Post-Immunotherapy RCC: Belzutifan + Lenvatinib Clinical Insights

The combination of belzutifan (WELIREG) plus lenvatinib (LENVIMA) met the primary endpoint of progression-free survival in the Phase 3 LITESPARK-011...
FDA Approval

Rucaparib FDA Approval: New PARP Inhibitor Options for BRCA-Mutated mCRPC

The FDA has granted full approval to rucaparib, an oral PARP inhibitor, for adults with BRCA1/2-mutated metastatic castration-resistant prostate cancer...

EMBARK Phase III: Enzalutamide Plus ADT Improves Survival in High-Risk Biochemically Recurrent Prostate Cancer

High-risk biochemically recurrent (hrBCR) prostate cancer represents a clinically challenging disease state, characterized by rising prostate-specific antigen (PSA) levels despite...
FDA Approval

Phase 3 AMPLITUDE Trial Supports FDA Approval of Akeega in mCSPC

FDA approves Akeega (niraparib + abiraterone acetate with prednisone) for BRCA2-mutated metastatic castration-sensitive prostate cancer, showing significant improvements in radiographic...

Latest Updates in Breast Cancer

Maintenance Therapy Intensification with Palbociclib Improves PFS in HR-Positive, HER2-Positive Metastatic Breast Cancer

In the phase 3 PATINA trial, adding the CDK4/6 inhibitor palbociclib to maintenance HER2-targeted and endocrine therapy significantly prolonged progression-free...
FDA Approval

FDA Approves Trastuzumab Deruxtecan (T-DXd) Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

The FDA has approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab for first-line treatment of unresectable or metastatic HER2-positive breast cancer....

Can Multimodal AI Be Trusted in the Clinic? New SABCS 2025 Data Support Its Role in Personalized Breast Cancer Care

At SABCS 2025, new data evaluated whether multimodal artificial intelligence (MMAI) can be trusted to support clinical decision-making in early-stage...

SABCS 2025: Redefining Endocrine-Based Care in HR+, HER2-Negative Breast Cancer Across Early and Metastatic Settings

Key data from SABCS 2025 highlight how endocrine-based, biology-driven strategies continue to reshape the management of ER-positive, HER2-negative breast cancer....
Emerging Clinical Evidence in HER2+ and HR+ Breast Cancer: Key Trials to Watch

SABCS 2025: Transforming HER2+ Breast Cancer Care: Key Updates from HER2CLIMB-05, DESTINY, and PHILA Trials

This article reviews recent pivotal HER2+ breast cancer trials, highlighting oral TKIs, antibody-drug conjugates, and chemotherapy-sparing strategies. Key studies—including HER2CLIMB-05,...

TUKYSA Combination Improves Progression-Free Survival in First-Line HER2+ Metastatic Breast Cancer: HER2CLIMB-05 Phase 3 Results

TUKYSA combo improves PFS in first-line HER2+ metastatic breast cancer maintenance, the first update to treatment paradigm since 2012.

Latest Updates in Lung Cancer

Osimertinib Plus Platinum–Pemetrexed Improves Overall Survival in EGFR-Mutated Advanced NSCLC (FLAURA2)

Final results from the phase III FLAURA2 trial demonstrate that adding platinum–pemetrexed chemotherapy to first-line osimertinib significantly improves overall survival...
FDA Approval

FDA Grants Approval for Subcutaneous Amibantamab (Rybrevant Faspro) in EGFR-Mutated NSCLC

The FDA has approved subcutaneous amivantamab (Rybrevant Faspro) for adult patients with advanced or metastatic EGFR-mutated NSCLC. In the Phase...
FDA Grants Traditional Approval to Tarlatamab-dlle for ES-SCLC After Phase 3 Survival Benefit

FDA Grants Traditional Approval to Tarlatamab-dlle for ES-SCLC After Phase 3 Survival Benefit

The FDA has granted full approval to Tarlatamab-dlle (Imdelltra) for patients with extensive-stage small-cell lung cancer progressing after platinum therapy....

AI Model Predicts EGFR Mutations from Pathology Slides in Real-Time Silent Trial for Lung Adenocarcinoma

AI can extract critical genetic insights directly from routine pathology slides, streamlining decisions and accelerating targeted therapy access.

FDA Approves First Maintenance Therapy for ES-SCLC: Lurbinectedin Plus Atezolizumab Extends Survival in IMforte Trial

FDA approves lurbinectedin plus atezolizumab for ES-SCLC maintenance, extending OS to 13.2 months vs 10.6 months with atezolizumab alone (HR...

EMPOWER-Lung 1: Cemiplimab Shows Sustained 5-Year Survival Benefit in Advanced NSCLC

Five-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy in advanced NSCLC patients with ≥50% PD-L1 expression.

Latest Updates in GI Cancer

HERIZON-GEA-01: Zanidatamab Plus Chemotherapy ± Tislelizumab Advances First-Line Treatment in HER2-Positive Gastroesophageal Adenocarcinoma

HERIZON-GEA-01 is a pivotal phase III trial evaluating zanidatamab-based regimens, with or without the PD-1 inhibitor tislelizumab, compared with trastuzumab...

Phase III COMMIT Study Shows Promising Frontline Approach for dMMR/MSI-H Metastatic Colorectal Cancer

The phase III COMMIT trial demonstrates that intensifying first-line immunotherapy with chemotherapy and antiangiogenic therapy can substantially improve outcomes for...

BREAKWATER Cohort 3: Early Integration of Encorafenib–Cetuximab Plus FOLFIRI Improves Response in BRAF V600E mCRC

Patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) represent a biologically distinct subgroup with historically poor outcomes and limited first-line,...

Perioperative Durvalumab Plus FLOT Improves Survival in Resectable Gastric and GEJ Cancer

The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with FLOT chemotherapy as the first and only perioperative immunotherapy for...

Zanzalintinib Plus Atezolizumab Improves Survival in Refractory MSS Metastatic Colorectal Cancer

Patients with refractory metastatic colorectal cancer (mCRC) and microsatellite-stable (MSS) disease have limited treatment options and historically derive minimal benefit...

From ‘Undruggable’ to Breakthrough: Pan-RAS Inhibitors Transform GI Oncology Practice

Pan-RAS inhibitors like RMC-6236 are showing unprecedented 30% response rates in previously treated pancreatic cancer, potentially ending the decades-long frustration...

Latest Updates in Oncology

ASCENT-03: Trodelvy Plus Pembrolizumab Demonstrates Significant PFS Benefit in First-Line Metastatic Triple-Negative Breast Cancer

ASCENT-03 trial shows Trodelvy plus pembrolizumab significantly improved PFS vs chemo plus pembrolizumab in first-line mTNBC patients.

FDA Approves First Maintenance Therapy for ES-SCLC: Lurbinectedin Plus Atezolizumab Extends Survival in IMforte Trial

FDA approves lurbinectedin plus atezolizumab for ES-SCLC maintenance, extending OS to 13.2 months vs 10.6 months with atezolizumab alone (HR...

FDA Grants Priority Review to Enhertu Plus Pertuzumab for First-Line HER2+ Metastatic Breast Cancer

FDA grants Priority Review for Enhertu plus pertuzumab in first-line HER2+ metastatic breast cancer, with decision expected April 2025.

FDA Approves Gemcitabine Intravesical System (Inlexzo) for BCG-Unresponsive Bladder Cancer

FDA approves gemcitabine intravesical system for BCG-unresponsive bladder cancer, showing 82% complete response rate in SunRISe-1 trial.

FDA Approves Modeyso as First Treatment for H3 K27M-Mutant Diffuse Midline Glioma

Modeyso, the first treatment option for this ultra-rare and aggressive brain tumor, is commercially available in the US.

Verzenio Achieves Overall Survival Milestone in Early Breast Cancer Competition”

Verzenio plus endocrine therapy offers statistically significant OS improvements over endocrine therapy alone in high-risk patients.