Researchers from Dana-Farber Cancer Institute are presenting four phase 3 clinical trials at the ESMO Congress 2025 in Berlin, focusing on breast, lung, and bladder cancers, with findings to be shared both in person and online from October 17 to October 21.

These presentations aim to showcase how Daiichi Sankyo’s ADC portfolio continues to advance cancer treatment standards and broaden options across multiple tumor types.

Results from the DESTINY-Breast09 trial have supported a priority review in the U.S. for ENHERTU as a first-line treatment for HER2-positive metastatic breast cancer, indicating its potential approval.

The safety profile of Trodelvy includes risks such as neutropenia, diarrhea, hypersensitivity reactions, nausea, vomiting, and issues related to reduced UGT1A1 activity, with specific management guidelines provided.

The VERITAC-2 trial emphasizes patient-reported outcomes, which could influence regulatory and commercial decisions by highlighting tolerability and quality of life benefits.

The company underscores its long-standing history in biotech and diagnostics, its commitment to sustainability, and its leadership in developing innovative, life-saving cancer treatments.

Several drugs, including investigational agents targeting specific genetic alterations or receptors, are discussed with the aim of improving efficacy and reducing toxicity.

Additional investigational agents are designed to target genetic mutations or receptors in cancers, aiming to enhance treatment efficacy and minimize side effects.

The TACTIVE-N study is evaluating vepdegestrant as a neoadjuvant therapy, potentially expanding its clinical application in cancer treatment.

Foundation Medicine emphasizes its mission to improve cancer diagnosis and treatment through advanced genomic tools, collaborating with biopharmaceutical companies to develop personalized therapies.

Foundation Medicine supports personalized cancer treatment with comprehensive diagnostic solutions and partnerships aimed at developing new therapies and improving patient outcomes.

Arvinas, based in Connecticut, is focused on developing protein degradation therapies using its PROTAC platform, with several investigational drugs including vepdegestrant in clinical development.

Genomic signatures like homologous recombination deficiency and HRD are being used to guide targeted therapies such as PARP inhibitors in cancers like ovarian and lung.

In lung cancer, the HARMONi-6 phase III study demonstrated that ivonescimab plus chemotherapy outperforms tislelizumab plus chemotherapy in first-line treatment of advanced squamous non-small cell lung cancer, showing significant progression-free survival benefits.

In renal cancer, plasma kidney injury molecule-1 (KIM-1) has been analyzed for its prognostic value, suggesting its utility in patient stratification and response prediction.

Research highlights novel therapeutic strategies, including immune checkpoint inhibitors, targeted therapies, and personalized treatments guided by circulating tumor DNA, reflecting a shift towards tailored approaches in gastrointestinal oncology.

Dr. Catherine Wu discussed the potential of therapeutic cancer vaccines to harness the immune system for durable, personalized tumor eradication, marking a new era in immunotherapy.

Genentech will present updates on its research, emphasizing its role in advancing cancer therapies and its commitment to innovation.

These clinical trials aim to address key challenges in oncology and improve patient outcomes through innovative research approaches.

Incyte highlights the significance of recent developments in addressing unmet medical needs for patients with solid tumors and remains committed to advancing cancer therapies.

The SOHO-01 phase 1/2 trial reports that sevabertinib shows meaningful and durable responses in previously treated HER2-mutant NSCLC, with the FDA granting priority review for this indication.

The event will feature updates, live content, and post-event coverage through a dedicated 'Spotlight On' page, emphasizing key data and analysis.

The studies demonstrate advancements in cancer treatment strategies, including novel therapies and combination treatments tailored to specific cancer types.

The Phase 1 study of INCA33890, a bispecific antibody targeting PD-1 and TGFβR2, focuses on advanced solid tumors, including colorectal cancer.

Vepdegestrant aims to address unmet needs in patients with ESR1 mutations and is part of a broader pipeline using PROTAC technology, with FDA approval for NDA and Fast Track designation.

Investigational drugs domvanalimab and zimberelimab, targeting TIGIT and PD-1, are being studied in combination therapies with promising survival data reported for gastric and esophageal cancers.

Research includes data on FoundationOne Monitor, a tissue-free assay for circulating tumor DNA, which shows promise in predicting treatment response, especially early reduction in ctDNA correlating with better outcomes in metastatic triple-negative breast cancer.

Key focus areas include prevention, screening, early diagnosis, recent breakthroughs, and the roles of new diagnostics and therapies in cancer care.

The FLAURA2 trial presented by Dr. Pasi Jänne showed that osimertinib, alone or with chemotherapy, improves survival in patients with EGFR-mutated advanced non-small cell lung cancer, especially those with poor prognostic factors.

Roche's IMvigor011 trial demonstrates that circulating tumor DNA-guided adjuvant treatment with atezolizumab significantly improves disease-free and overall survival in muscle-invasive bladder cancer, with ongoing efforts to refine treatment strategies.

In genitourinary cancers, there is a focus on developing novel agents and identifying predictive and prognostic biomarkers, especially in kidney cancer.

In gynecologic cancers, advances in targeted therapies and ADCs are anticipated, with ongoing phase 3 trials that could influence future treatment practices, particularly in endometrial cancer.

Vepdegestrant, an investigational PROTAC estrogen receptor degrader, has received FDA approval for NDA and Fast Track designation, with Arvinas collaborating with Pfizer on this drug, which aims to treat ER+/HER2- advanced breast cancer with ESR1 mutations.

Arvinas’s broader pipeline includes first-in-class medicines in oncology and autoimmunity, with operations across North America, Europe, and Asia.

Additional results from the ASCENT-04/KEYNOTE-D19 study will evaluate quality of life in patients receiving Trodelvy plus Keytruda versus chemotherapy in metastatic triple-negative breast cancer.

In breast cancer, key topics include antibody-drug conjugates and new hormone receptor–positive therapies, especially CDK 4/6 inhibitors combined with PI3K/mTOR inhibitors.

Updated findings from the phase III ALEX study support adjuvant Alecensa as the standard of care for resected ALK-positive NSCLC, with data showing improved disease-free survival and overall survival.