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AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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Based on the topline results from the EPCORE® DLBCL-1 trial, AbbVie along with partner Genmab will e...

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AI Summary

AbbVie announces positive topline results from EPCORE® DLBCL-1 trial for epcoritamab. Epcoritamab improved progression-free survival in DLBCL patients receiving chemotherapy. Regulatory discussions are set to follow these successful trial results. Overall survival improvements were not statistically significant in the trial. Adverse events align with existing knowledge of epcoritamab's safety profile.

Sentiment Rationale

Epcoritamab's effectiveness in treating DLBCL could lead to increased demand for AbbVie's products. Similar trial successes have positively impacted stock valuations in the biotech sector.

Trading Thesis

Successful regulatory outcomes and market introduction could enhance long-term revenue. For instance, increased sales of new therapies usually bolster profitability over time.

Market-Moving

  • AbbVie announces positive topline results from EPCORE® DLBCL-1 trial for epcoritamab.
  • Epcoritamab improved progression-free survival in DLBCL patients receiving chemotherapy.
  • Regulatory discussions are set to follow these successful trial results.

Key Facts

  • AbbVie announces positive topline results from EPCORE® DLBCL-1 trial for epcoritamab.
  • Epcoritamab improved progression-free survival in DLBCL patients receiving chemotherapy.
  • Regulatory discussions are set to follow these successful trial results.
  • Overall survival improvements were not statistically significant in the trial.
  • Adverse events align with existing knowledge of epcoritamab's safety profile.

Companies Mentioned

  • GMAB (GMAB)
  • NVS (NVS)
  • AMGN (AMGN)

Research Analysis

The study's success could lead to expanded market opportunities for AbbVie, influencing investor sentiment.

AbbVie Reports Positive Phase 3 EPCORE® DLBCL-1 Trial Results for Epcoritamab in Relapsed/Refractory DLBCL

AbbVie (NYSE: ABBV) has announced promising topline results from its Phase 3 EPCORE® DLBCL-1 trial. This pivotal study evaluated epcoritamab, a subcutaneously administered T-cell engaging bispecific antibody, against the investigator's choice of chemoimmunotherapy in adult patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The results indicate a significant improvement in progression-free survival, prompting AbbVie and its partner Genmab to engage with global regulatory authorities regarding potential next steps.

Key Findings from the EPCORE® DLBCL-1 Trial

The EPCORE® DLBCL-1 trial, which involved 483 patients with relapsed or refractory DLBCL, demonstrated the following:

  • Improvement in Progression-Free Survival (PFS): Hazard Ratio (HR) of 0.74 (95% Confidence Interval: 0.60 to 0.92).
  • Increased Complete Response Rates (CRR), Duration of Response (DoR), and Time to Next Treatment: Measurements showed favorable outcomes for patients treated with epcoritamab.
  • No Statistically Significant Overall Survival (OS) Improvement: The study recorded an HR of 0.96 (95% CI: 0.77 to 1.20).

Background on DLBCL and Epcoritamab

Diffuse large B-cell lymphoma is the most prevalent form of non-Hodgkin lymphoma, comprising approximately 25-30% of all NHL cases worldwide. In the United States, about 25,000 new cases are diagnosed annually. DLBCL can affect lymph nodes and organs outside the lymphatic system, with higher incidence rates in older individuals and men.

Epcoritamab, branded as EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU, is designed to target CD3 on T cells and CD20 on B cells, promoting the immune system's ability to fight against CD20-positive cancers. It has been approved in over 65 countries for specific lymphoma indications.

Strategic Responses and Future Outlook

In response to the findings, AbbVie and Genmab will analyze the data and consider external factors, including the impact of the COVID-19 pandemic on trial execution. They plan to submit the full data for presentation at upcoming medical meetings and will work closely with regulatory authorities to discuss further regulatory plans.

About the EPCORE® DLBCL-1 Clinical Trial

The EPCORE® DLBCL-1 trial (NCT04628494) is a global, open-label, multi-center, randomized study designed to evaluate the efficacy of epcoritamab compared to standard chemotherapy choices such as rituximab plus gemcitabine plus oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) in eligible patients. The trial commenced on January 13, 2021, and is ongoing.

Conclusive Remarks

AbbVie continues to prioritize the development of epcoritamab, with plans to explore its use in combination therapies across a wide array of hematologic malignancies. As this potentially transformative treatment option advances, it may signify a pivotal moment in the management of relapsed or refractory DLBCL, representing hope for many affected patients.

For further details about the trial, please visit ClinicalTrials.gov.

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