ASCO 2025 daily highlights: Sunday 1st June
Plenary Session
Phase 3 ATOMIC trial evolving Colon Cancer Treatment with Atezolizumab
Results of randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC).
Atezolizumab, combined with mFOLFOX6 chemotherapy, is set to transform the treatment landscape for stage III colon cancer with deficient mismatch repair (dMMR).
- Patients receiving atezolizumab with mFOLFOX6 showed a significant improvement in Disease Free Survival (DFS), with a three-year DFS rate of 86.4% compared to 76.6% for the chemotherapy alone group.
- The efficacy of atezolizumab was consistent across various subgroups, highlighting the broad applicability of this approach.
- Atezolizumab combined with mFOLFOX6 was well tolerated, with manageable adverse events.
Atezolizumab with mFOLFOX6 therapy represents a new era in colon cancer therapy, offering hope for better outcomes and a brighter future for patients.
Strategic next steps for pharma industry
- Further stratification of patients: Despite the combination treatment of 6 months of FOLFOX and 1 year of atezolizumab, there are still 13% recurrences. This highlights the need for continued monitoring and development of biomarkers to access those patients most likely to relapse. There is also a need to identify patients
- Focus on Phase Contributions: Examining the contributions of different phases (neoadjuvant and extended adjuvant) of treatment can provide insights into the most critical aspects of the therapy. This can help refine treatment strategies and improve overall efficacy
Potential as a new standard treatment in resected head and neck squamous cell carcinoma for the first time in two decades...
Results of NIVOPOSTOP (GORTEC 2018-01): A phase III randomized trial of adjuvant nivolumab added to radio-chemotherapy in patients with resected head and neck squamous cell carcinoma at high risk of relapse.
Nivolumab, combined with cisplatin-radiotherapy (CRT), is set to change the treatment landscape for resected locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). The Phase 3 NIVOPOSTOP study has demonstrated that this combination significantly improves disease-free survival (DFS) compared to the current standard of care.
- Patients receiving nivolumab with CRT showed a significant improvement in DFS, with a three-year DFS rate of 63.1% compared to 52.5% for the CRT alone group.
- The efficacy of nivolumab was consistent across various subgroups, highlighting the broad applicability of this approach.
- Nivolumab combined with CRT was well tolerated, with fewer grade 4 adverse events compared to CRT alone.
Nivolumab represents a new era in head and neck cancer therapy, offering hope for better outcomes and a brighter future for patients.
Considerations for pharma and physicians
The critical reviewer of this clinical trial brought up some areas that need clarification or further consideration
- Definition of high risk: What is meant by “High Risk of relapse” in terms of immunotherapy this needs defined
- Promotion of MDT discussions: In a world where anti-PD-L1 adjuvant and neoadjuvant therapies are available, multi-disciplinary discussion of patient treatment management is optimal
- Laboratory Testing: Granular analysis of PD-L subgroups would be advisable
- Reporting of OS: Overall survival data needed to provide confidence for treating physicians
Transforming Polycythemia Vera Treatment with Rusfertide
Results from Part 1a of VERIFY, a phase 3, double-blind, placebo (PBO)-controlled study of rusfertide for treatment of polycythemia vera (PV).
Polycythemia vera (PV) is a condition characterized by the overproduction of red blood cells. Rusfertide is a new, self-injected peptide that mimics hepcidin and reduces erythrocytosis. The VERIFY study is a global phase 3 trial assessing Rusfertide versus placebo (PBO) in patients with PV who require frequent phlebotomies.
Review of study concluded that Rusfertide is revolutionizing the management of polycythemia vera (PV). This innovative therapy has shown significant promise in Part 1a of the phase 3 VERIFY study, meeting its primary and all key secondary endpoints. Patients treated with Rusfertide experienced a substantial reduction in the need for phlebotomies and improved hematocrit control, along with significant improvements in fatigue and symptom scores.
As we look to the future
- Additional data from longer-term follow-up will further solidify Rusfertide's role in PV treatment.
- This groundbreaking therapy offers new hope for patients, aiming to reduce the need for cytoreduction and potentially lower the risk of progression to more severe conditions like myelofibrosis or acute myeloid leukemia.
Camizestrant represents a new era in personalized breast cancer therapy, offering hope for better outcomes
Results of Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.
Camizestrant, combined with CDK4/6 inhibitors, is set to transform the treatment landscape for HR+/HER2– advanced breast cancer. The groundbreaking SERENA-6 trial has demonstrated that using ctDNA to detect ESR1 mutations and guide therapy changes can significantly improve progression-free survival (PFS) for patients.
- Patients switching to camizestrant showed a median PFS of 16.0 months, nearly doubling the 9.2 months seen with continued AI therapy.
- The PFS advantage was observed across all patient subgroups, highlighting the broad applicability of this approach.
- Camizestrant was well tolerated, with a safety profile consistent with existing treatments.
Strategic steps for pharma industry and impact on laboratory
- Undetermined Clinical Utility: The clinical utility of serial ctDNA testing as a treatment strategy for ER+ metastatic breast cancer (MBC) is not yet determined. This means that more evidence is needed to establish the effectiveness and practicality of using ctDNA monitoring in clinical practice.
- Need for Additional Outcome Data: There is a need for more information on other outcomes before this treatment strategy can be widely adopted. This includes data on long-term efficacy, safety, and overall survival benefits
- Impact of demand of ctDNA testing on healthcare system and patients-How often do patients need tested, how will they be tested and what will be the cost
- Different ctDNA Platforms: How do different ctDNA platforms compare in terms of accuracy and reliability?
- Applicability: Can this strategy be applied to other mutations, drugs, or diseases?
Revolutionizing Gastric Cancer Treatment with Durvalumab
Results of event-free survival (EFS) in MATTERHORN: A randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC).
Durvalumab combined with FLOT chemotherapy is set to transform the treatment landscape for resectable gastric and gastroesophageal junction cancer (GC/GEJC). The MATTERHORN study has demonstrated that this combination significantly improves event-free survival (EFS) compared to the current standard of care.
- Patients receiving durvalumab with FLOT showed a significant improvement in EFS, with the median EFS not yet reached, compared to 32.8 months for the placebo group.
- The 24-month EFS rate was higher for the durvalumab group, highlighting the long-term benefits of this combination.
- Durvalumab combined with FLOT was well tolerated, with similar adverse event rates to the placebo group.
Durvalumab represents a new era in gastric cancer therapy, offering hope for better outcomes and a brighter future for patients.
Considerations for treating physicians
Should we offer for all? The consensus is to offer the treatment to all patients. There is no subgroup to exclude, and it is recommended for all PD-L1 subgroups.
Will OS be positive? While the MATTERHORN study's answer is "TBD," a promising curve shape and a strong design with a p-value threshold of 0.049 at final analysis.
Strategic next steps for pharma
- Expand Research and Clinical Trials: Further research and clinical trials are essential to validate and expand the use of D-FLOT in different patient subgroups.
- Leverage MATTERHORN's Rich Dataset: The MATTERHORN study contains an incredibly rich dataset that can be explored to identify new biomarkers and improve personalized treatment approaches. This includes examining other clinical and biomarker subgroups.
- Investigate ctDNA Performance: Exploring the performance of circulating tumor DNA (ctDNA) can enhance early detection and monitoring of cancer progression or response to treatment. This can lead to more precise and timely interventions.
- Optimize Treatment Protocols: Analyzing the features of responders and non-responders will help optimize treatment protocols and improve patient outcomes.
- Focus on Phase Contributions: Examining the contributions of different phases (neoadjuvant, adjuvant and extended adjuvant) of treatment can provide insights into the most critical aspects of the therapy. This can help refine treatment strategies and improve overall efficacy.
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