Genmab Receives Approval for TEPKINLY in Combination Therapy for Relapsed Follicular Lymphoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Genmab (GMAB) announced that the European Commission granted marketing authorization for TEPKINLY in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma. The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial that evaluated fixed-duration TEPKINLY + R2 compared to standard of care R2. "Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cite University, Hopital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option." Epcoritamab is being co-developed by Genmab and AbbVie (ABBV) as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
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Analyst Views on GMAB
Wall Street analysts forecast GMAB stock price to rise
7 Analyst Rating
5 Buy
2 Hold
0 Sell
Moderate Buy
Current: 28.010
Low
26.00
Averages
38.50
High
48.00
Current: 28.010
Low
26.00
Averages
38.50
High
48.00
About GMAB
Genmab A/S is a Denmark-based international biotechnology company. It specializes in the creation and development of antibody therapeutics for the treatment of cancer. The Company is the creator of the approved antibodies: DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications, Kesimpta for the treatment of adults with relapsing forms of multiple sclerosis, TEPEZZA (teprotumumab) for the treatment of thyroid eye disease and FASPRO, for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy Arzerra, approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Genmab develops a broad clinical and pre-clinical product pipeline, and owns four antibody technologies, DuoBody bispecific platform, HexaBody platform, DuoHexaBody platform & HexElect platform.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Genmab's TEPKINLY Approved by EU for Follicular Lymphoma
- Therapy Approval: Genmab A/S announced that the European Commission has approved TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab, marking a significant breakthrough as the first bispecific therapy for relapsed or refractory follicular lymphoma.
- Clinical Trial Results: Based on the EPCORE FL-1 trial results, TEPKINLY + R2 demonstrated a 79% reduction in the risk of disease progression or death (HR 0.21, p<0.0001), with overall response rates reaching 96%, significantly higher than the 81% seen with R2 alone, indicating its clinical significance.
- Treatment Paradigm Shift: TEPKINLY + R2 offers a chemotherapy-free treatment option that may change the treatment paradigm for follicular lymphoma, particularly for patients facing recurrent relapses, providing more durable responses and improving quality of life.
- Safety Profile: The safety profile of the combination was consistent with known effects of epcoritamab and R2, with 44% of patients experiencing serious adverse events, including common reactions like neutropenia, rash, and fatigue, necessitating close monitoring in clinical applications.
See More
TEPKINLY® Approved in Europe for Relapsed Follicular Lymphoma Treatment
- Clinical Trial Results: The Phase 3 EPCORE®FL-1 trial demonstrated a 79% reduction in the risk of disease progression or death with TEPKINLY + R2, indicating significant efficacy in treating relapsed follicular lymphoma and the potential to change existing treatment paradigms.
- Efficacy Data: The overall response rate for TEPKINLY + R2 reached 96%, compared to 81% for R2 alone, highlighting a higher complete response rate of 74% among patients treated with TEPKINLY, showcasing its potential clinical value.
- Safety Analysis: The safety profile of TEPKINLY + R2 in the EPCORE FL-1 study was consistent with known profiles of individual regimens, with 44% of patients experiencing serious adverse reactions, but management and monitoring measures provided safety assurance for patients.
- Market Impact: The approval of TEPKINLY offers a new treatment option for patients with relapsed follicular lymphoma, particularly at first relapse, which could significantly improve patient quality of life and enhance Genmab's market position in oncology.
See More
European Commission Approves Tepkinly Label Expansion for Blood Cancer Therapy
- Label Expansion Approved: The European Commission has authorized Tepkinly as a first-line treatment option for patients with relapsed or refractory follicular lymphoma, marking its legalization across 27 EU member states, Norway, Iceland, and Liechtenstein.
- Clinical Trial Support: This approval is backed by data from AbbVie and Genmab's Phase 3 EPCORE FL-1 trial, demonstrating significant advantages in treatment efficacy for the bispecific antibody therapy, further solidifying its market position.
- Growing Market Demand: Follicular lymphoma has a higher prevalence in Europe, with rates ranging from 11%-29%, compared to 2%-18% in other regions, indicating substantial market potential for Tepkinly to meet the increasing patient demand.
- Previous Approval Context: Tepkinly was previously approved in the U.S. under the brand name Epkinly as a monotherapy for patients with diffuse large B-cell lymphoma and relapsed follicular lymphoma who had undergone at least two prior lines of systemic therapy, showcasing its broad applicability across different indications.
See More
Genmab's Tepkinly Approved by European Commission
- Drug Approval: Genmab announced that its cancer drug Tepkinly, in combination with lenalidomide, has been approved by the European Commission, marking a significant milestone that will strongly support the company's market expansion in cancer treatment.
- Market Potential: The approval of Tepkinly is expected to significantly enhance Genmab's revenue potential, particularly in the European market, addressing the growing patient demand and strengthening the company's competitive position in the biopharmaceutical industry.
- Strategic Partnerships: This approval lays the groundwork for potential collaborations between Genmab and other pharmaceutical companies, further driving its global business development and innovation capabilities.
- Investor Confidence: This approval news is likely to boost investor confidence in Genmab, with expectations of a positive impact on its stock price, reflecting the market's optimistic outlook on its future growth prospects.
See More
AbbVie's Epkinly Shows Significant Survival Benefits in Lymphoma Patients
- Clinical Trial Results: AbbVie's experimental T-cell engaging bispecific antibody Epkinly (epcoritamab) combined with Revlimid (lenalidomide) demonstrated significant improvements in progression-free survival for large B-cell lymphoma patients, reducing disease progression and death by 60% and 56%, respectively, compared to the control group receiving Rituxan (rituximab), gemcitabine, and oxaliplatin.
- Significant Treatment Impact: The phase 3 EPCOREDLBCL-4 trial results indicate that patients in the Epkinly group experienced markedly lower rates of disease progression and mortality, providing a new treatment option that could potentially redefine the standard of care for large B-cell lymphoma.
- Market Potential: With Epkinly approved for third-line treatment of large B-cell lymphoma, its combination with Revlimid may attract increased attention from clinicians, thereby driving AbbVie's market share growth in this therapeutic area.
- Strategic Partnership: AbbVie markets Epkinly in collaboration with Genmab (GMAB), a partnership that not only enhances both companies' competitive positions in the biopharmaceutical sector but also lays the groundwork for future joint research and market expansion efforts.
See More
Genmab Phase 3 Study Success
- Clinical Trial Success: Genmab announced that its Phase 3 study of epcoritamab combined with lenalidomide successfully met its primary endpoint, demonstrating the efficacy of this combination in treating specific cancer types, potentially offering new treatment options for patients.
- Significant Market Potential: The success of this study not only enhances Genmab's competitive position in the market but may also increase its share in the global oncology treatment market, likely attracting more investor interest.
- Future Development Plans: Genmab plans to submit regulatory applications in the coming months, and if approved, this will accelerate the commercialization process of the therapy, leading to substantial revenue growth for the company.
- Strategic Collaboration Opportunities: This success opens up potential collaboration opportunities between Genmab and pharmaceutical companies, which could lead to more R&D partnerships and market promotions, further strengthening its influence in the biopharmaceutical sector.
See More
Genmab's TEPKINLY Approved by EU for Follicular Lymphoma
- Therapy Approval: Genmab A/S announced that the European Commission has approved TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab, marking a significant breakthrough as the first bispecific therapy for relapsed or refractory follicular lymphoma.
- Clinical Trial Results: Based on the EPCORE FL-1 trial results, TEPKINLY + R2 demonstrated a 79% reduction in the risk of disease progression or death (HR 0.21, p<0.0001), with overall response rates reaching 96%, significantly higher than the 81% seen with R2 alone, indicating its clinical significance.
- Treatment Paradigm Shift: TEPKINLY + R2 offers a chemotherapy-free treatment option that may change the treatment paradigm for follicular lymphoma, particularly for patients facing recurrent relapses, providing more durable responses and improving quality of life.
- Safety Profile: The safety profile of the combination was consistent with known effects of epcoritamab and R2, with 44% of patients experiencing serious adverse events, including common reactions like neutropenia, rash, and fatigue, necessitating close monitoring in clinical applications.
See More
TEPKINLY® Approved in Europe for Relapsed Follicular Lymphoma Treatment
- Clinical Trial Results: The Phase 3 EPCORE®FL-1 trial demonstrated a 79% reduction in the risk of disease progression or death with TEPKINLY + R2, indicating significant efficacy in treating relapsed follicular lymphoma and the potential to change existing treatment paradigms.
- Efficacy Data: The overall response rate for TEPKINLY + R2 reached 96%, compared to 81% for R2 alone, highlighting a higher complete response rate of 74% among patients treated with TEPKINLY, showcasing its potential clinical value.
- Safety Analysis: The safety profile of TEPKINLY + R2 in the EPCORE FL-1 study was consistent with known profiles of individual regimens, with 44% of patients experiencing serious adverse reactions, but management and monitoring measures provided safety assurance for patients.
- Market Impact: The approval of TEPKINLY offers a new treatment option for patients with relapsed follicular lymphoma, particularly at first relapse, which could significantly improve patient quality of life and enhance Genmab's market position in oncology.
See More
European Commission Approves Tepkinly Label Expansion for Blood Cancer Therapy
- Label Expansion Approved: The European Commission has authorized Tepkinly as a first-line treatment option for patients with relapsed or refractory follicular lymphoma, marking its legalization across 27 EU member states, Norway, Iceland, and Liechtenstein.
- Clinical Trial Support: This approval is backed by data from AbbVie and Genmab's Phase 3 EPCORE FL-1 trial, demonstrating significant advantages in treatment efficacy for the bispecific antibody therapy, further solidifying its market position.
- Growing Market Demand: Follicular lymphoma has a higher prevalence in Europe, with rates ranging from 11%-29%, compared to 2%-18% in other regions, indicating substantial market potential for Tepkinly to meet the increasing patient demand.
- Previous Approval Context: Tepkinly was previously approved in the U.S. under the brand name Epkinly as a monotherapy for patients with diffuse large B-cell lymphoma and relapsed follicular lymphoma who had undergone at least two prior lines of systemic therapy, showcasing its broad applicability across different indications.
See More
Genmab's Tepkinly Approved by European Commission
- Drug Approval: Genmab announced that its cancer drug Tepkinly, in combination with lenalidomide, has been approved by the European Commission, marking a significant milestone that will strongly support the company's market expansion in cancer treatment.
- Market Potential: The approval of Tepkinly is expected to significantly enhance Genmab's revenue potential, particularly in the European market, addressing the growing patient demand and strengthening the company's competitive position in the biopharmaceutical industry.
- Strategic Partnerships: This approval lays the groundwork for potential collaborations between Genmab and other pharmaceutical companies, further driving its global business development and innovation capabilities.
- Investor Confidence: This approval news is likely to boost investor confidence in Genmab, with expectations of a positive impact on its stock price, reflecting the market's optimistic outlook on its future growth prospects.
See More
AbbVie's Epkinly Shows Significant Survival Benefits in Lymphoma Patients
- Clinical Trial Results: AbbVie's experimental T-cell engaging bispecific antibody Epkinly (epcoritamab) combined with Revlimid (lenalidomide) demonstrated significant improvements in progression-free survival for large B-cell lymphoma patients, reducing disease progression and death by 60% and 56%, respectively, compared to the control group receiving Rituxan (rituximab), gemcitabine, and oxaliplatin.
- Significant Treatment Impact: The phase 3 EPCOREDLBCL-4 trial results indicate that patients in the Epkinly group experienced markedly lower rates of disease progression and mortality, providing a new treatment option that could potentially redefine the standard of care for large B-cell lymphoma.
- Market Potential: With Epkinly approved for third-line treatment of large B-cell lymphoma, its combination with Revlimid may attract increased attention from clinicians, thereby driving AbbVie's market share growth in this therapeutic area.
- Strategic Partnership: AbbVie markets Epkinly in collaboration with Genmab (GMAB), a partnership that not only enhances both companies' competitive positions in the biopharmaceutical sector but also lays the groundwork for future joint research and market expansion efforts.
See More
Genmab Phase 3 Study Success
- Clinical Trial Success: Genmab announced that its Phase 3 study of epcoritamab combined with lenalidomide successfully met its primary endpoint, demonstrating the efficacy of this combination in treating specific cancer types, potentially offering new treatment options for patients.
- Significant Market Potential: The success of this study not only enhances Genmab's competitive position in the market but may also increase its share in the global oncology treatment market, likely attracting more investor interest.
- Future Development Plans: Genmab plans to submit regulatory applications in the coming months, and if approved, this will accelerate the commercialization process of the therapy, leading to substantial revenue growth for the company.
- Strategic Collaboration Opportunities: This success opens up potential collaboration opportunities between Genmab and pharmaceutical companies, which could lead to more R&D partnerships and market promotions, further strengthening its influence in the biopharmaceutical sector.
See More
