Latest Updates From OncoNexus

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...
IL-15 Receptor Lymphocyte–Stimulating Agent NAI + BCG in BCG-Unresponsive Papillary-Only NMIBC

ANKTIVA® Plus BCG Demonstrates Durable Response, Bladder Preservation, and 96% Survival in BCG-Unresponsive Papillary NMIBC

This article reviews long-term outcomes of the IL-15 receptor agonist nogapendekin alfa inbakicept (NAI) combined with intravesical bacillus Calmette-Guérin (BCG)...

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 and Pivotal Trials in Lymphoma: Key Insights Shaping Modern Practice

ASH 2025: Emerging Clinical Evidence and Pivotal Trials in Lymphoma: Key Insights Shaping Modern Practice

Explore recent pivotal trials in CLL, SLL, and high-risk MCL, highlighting next-generation BTK inhibitors, early CAR-T integration, and chemotherapy-sparing approaches....

ASH 2025: Advances in Individualized Leukemia Care: Insights from GIMEMA and AUGMENT-101 Trials

Explore recent pivotal trials in AML and CLL, highlighting MRD-guided therapy, targeted agents, and chemotherapy-sparing strategies. GIMEMA and AUGMENT-101 studies...

ASH 2025: Optimizing MM Care: Key Trials and Consensus Updates on Targeted, Immune-Based, and Risk-Adapted Approaches

Explore recent pivotal trials and consensus updates in multiple myeloma, including MajesTEC-3, COBRA, and the first IMS–IMWG high-risk definition. This...

Latest Updates in Genitourinary Oncology

IL-15 Receptor Lymphocyte–Stimulating Agent NAI + BCG in BCG-Unresponsive Papillary-Only NMIBC

ANKTIVA® Plus BCG Demonstrates Durable Response, Bladder Preservation, and 96% Survival in BCG-Unresponsive Papillary NMIBC

This article reviews long-term outcomes of the IL-15 receptor agonist nogapendekin alfa inbakicept (NAI) combined with intravesical bacillus Calmette-Guérin (BCG)...
A New Era in MIBC: Perioperative Pembrolizumab + Enfortumab Vedotin Approved for Cisplatin-Ineligible Patients

A New Era in MIBC: Perioperative Pembrolizumab + Enfortumab Vedotin Approved for Cisplatin-Ineligible Patients

On November 21, 2025, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda or Keytruda Qlex) combined with enfortumab vedotin-ejfv...

Prospective DRIVE Study Demonstrates Strong Diagnostic Performance of CxBladder Triage Plus in Hematuria Evaluation

The CxBladder Triage Plus DRIVE study showed high accuracy in detecting urothelial carcinoma in patients with hematuria, with 94% sensitivity...

New CMS J-Code Set to Enhance Adoption of Mitomycin Therapy for Recurrent LG-IR-NMIBC

CMS has assigned a permanent J-code (J9282) to ZUSDURI, an intravesical mitomycin therapy for recurrent low-grade, intermediate-risk NMIBC, effective January...

IMvigor011: Signatera™ ctDNA Testing Guides Adjuvant Atezolizumab Benefit in Muscle-Invasive Bladder Cancer

Signatera-positive patients treated with atezolizumab had statistically significant improvements in disease-free and overall survival.

KEYNOTE-905: First Perioperative Therapy to Demonstrate Survival Benefit in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

First positive Phase 3 trial shows perioperative immunotherapy combination addresses critical gap for cisplatin-ineligible patients.

Latest Updates in Breast Cancer

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.

Datroway Achieves First OS Benefit in Immunotherapy-Ineligible Triple-Negative Breast Cancer

First cancer drug to show OS benefit vs chemotherapy for TNBC patients ineligible for immunotherapy in landmark phase 3 trial.

Verzenio Demonstrates Overall Survival Benefit in High-Risk Early Breast Cancer: Seven-Year monarchE Results

Two years of Verzenio plus endocrine therapy shows OS benefit in high-risk HR+, HER2- early breast cancer at seven-year follow-up.

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.

Latest Updates in Lung Cancer

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.

Zipalertinib Demonstrates Activity in EGFR-Mutant NSCLC: Updated REZILIENT Trial Results from IASLC 2025

Zipalertinib demonstrated 27.4% response rate in EGFR ex20ins NSCLC patients post-amivantamab with 8.5-month duration of response.

Ideaya Advances Precision Oncology Pipeline with Positive Data from Three Cancer Drug Candidates

Ideaya presents promising data across three cancer drugs: darovasertib (76% response), IDE849 (58% response), and IDE397 combo (57% response).

Latest Updates in GI Cancer

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...

PurIST® Algorithm Validated for Pancreatic Cancer First-Line Therapy Selection in Landmark Real-World Study

Real-world evidence demonstrates PurIST's ability to guide first-line treatment decisions and improve outcomes for patients.

Pan-GI Cancer Microbiota Analysis Reveals Universal Prognostic Bacterial Signatures

Fifteen bacterial genera consistently associated with prognosis across six GI tumor types, predicting survival and metastasis risk.

Targeting ‘Undruggable’ KRAS in Pancreatic Cancer: Clinical Breakthroughs and Resistance Strategies

KRASG12C inhibitors achieve 21-33% response rates with superior safety vs standard chemo in PDAC patients.

Adjuvant Camrelizumab Plus Chemoradiation Improves Survival in Resected Cholangiocarcinoma and Gallbladder Cancer: ACCORD Trial Results

Camrelizumab plus chemoradiation improved 3-year OS to 58.2% vs 30.5% observation in resected cholangiocarcinoma/gallbladder cancer.

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.