AbbVie Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma
Rhea-AI Summary
AbbVie (NYSE: ABBV) received European Commission marketing authorization for TEPKINLY (epcoritamab) + lenalidomide + rituximab (R2) to treat adult relapsed or refractory follicular lymphoma in the second-line setting. This fixed‑duration, chemotherapy‑free, bispecific-based regimen is the first of its kind approved in Europe.
In Phase 3 EPCORE FL-1, TEPKINLY + R2 reduced risk of progression or death by 79% (HR 0.21) versus R2, achieved 96% overall response and 74% complete response, versus 81% and 43% for R2. Serious adverse reactions occurred in 44% of patients, including cytokine release syndrome and infections.
Positive
- European Commission approval for TEPKINLY + R2 in second-line relapsed or refractory follicular lymphoma
- EPCORE FL-1: 79% reduction in risk of progression or death versus R2 alone (HR 0.21)
- Overall response rate 96% and complete response rate 74% with TEPKINLY + R2
- First approved bispecific-based, fixed-duration, chemotherapy-free regimen for this setting in Europe
Negative
- Serious adverse reactions in 44% of patients receiving TEPKINLY + R2
- Common (≥20%) adverse reactions include neutropenia, rash, infections, fatigue, diarrhea, anemia, thrombocytopenia and cytokine release syndrome
- Serious adverse reactions ≥5% included cytokine release syndrome, pneumonia, COVID-19 and febrile neutropenia
News Market Reaction – ABBV
In the Jul 6 session, ABBV declined 2.42%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 29 | Phase 3 clinical data | Positive | -1.1% | Positive Phase 3 epcoritamab plus lenalidomide data in R/R DLBCL versus R-GemOx. |
| Jun 29 | Regulatory opinion | Positive | +0.4% | Positive CHMP opinion for upadacitinib in severe alopecia areata in the EU. |
| Jun 29 | Regulatory opinion | Positive | +0.4% | Positive CHMP opinion for upadacitinib in non-segmental vitiligo in the EU. |
| Jun 26 | FDA approval | Positive | +0.4% | FDA approval of SKYRIZI for pediatric plaque psoriasis and psoriatic arthritis. |
| Jun 26 | Earnings call notice | Neutral | +4.2% | Scheduling announcement for AbbVie’s second-quarter 2026 earnings release and call. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent AbbVie news has usually seen modestly positive price reactions, with one notable divergence on strong epcoritamab clinical data.
Key Terms
progression-free survival medical
overall response rate medical
complete response medical
cytokine release syndrome medical
non-hodgkin lymphoma medical
bispecific-based therapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- TEPKINLY® (epcoritamab) plus lenalidomide and rituximab (R2) is the first and only bispecific-based therapy approved in
Europe for the treatment of relapsed or refractory follicular lymphoma in the second-line setting, offering a chemotherapy-free option - In the Phase 3 EPCORE® FL-1 trial, fixed-duration TEPKINLY + R2 achieved statistically significant improvement of progression-free survival and overall response rates compared to R2, with approximately three out of four patients achieving a complete response
"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 Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de
The marketing authorization is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R2 compared to R2 alone in patients with R/R FL. The study demonstrated TEPKINLY + R2 reduced the risk of disease progression or death by
The safety profile of TEPKINLY + R2 in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R2). In the trial, the most common (≥
"There remains a critical need for new treatment options to improve outcomes for patients with relapsed or refractory follicular lymphoma, particularly in earlier lines of therapy," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This approval is important because it brings an effective treatment option to patients across
FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases.1 FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent.2 FL is considered incurable, and there is no standard of care treatment for third-line or later FL.1,3 Patients who achieve remission also often experience relapse.4,5,6
"A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment," said Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation. "The approval of epcoritamab now in combination with R2 in
About the EPCORE® FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus lenalidomide and rituximab (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Patients were randomized to receive epcoritamab in combination with R2 (n=243) or R2 alone (n=245). Patients received epcoritamab in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026.
About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.6
Epcoritamab (approved under the brand name EPKINLY® in the
AbbVie and Genmab continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.
EU Indications and Important Safety Information about Tepkinly® ▼ (epcoritamab)
Indications
Tepkinly (epcoritamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Important Safety Information
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use
Cytokine release syndrome (CRS)
CRS, which may be life-threatening or fatal, occurred in patients receiving Tepkinly. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea.
Most CRS events occurred in Cycle 1 and were associated with the first full dose of Tepkinly. Administer prophylactic corticosteroids to mitigate the risk of CRS. Patients should be monitored for signs and symptoms of CRS following Tepkinly administration. At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as appropriate. Patients should be counselled on the signs and symptoms associated with CRS and patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of Tepkinly based on the severity of CRS.
Haemophagocytic lymphohistiocytosis (HLH)
Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving Tepkinly. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias. HLH should be considered when the presentation of CRS is atypical or prolonged. Patients should be monitored for clinical signs and symptoms of HLH. For suspected HLH, Tepkinly must be interrupted for diagnostic workup and treatment for HLH initiated. If HLH is confirmed, administration of Tepkinly should be discontinued.
Immune effector cell-associated neurotoxicity syndrome (ICANS)
ICANS, including fatal events, have occurred in patients receiving Tepkinly. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema. The majority of cases of ICANS occurred within Cycle 1 of Tepkinly treatment, however some occurred with delayed onset. Patients should be monitored for signs and symptoms of ICANS following Tepkinly administration. At the first signs or symptoms of ICANS treatment with corticosteroids and non-sedating-anti-seizure medicinal products should be instituted as appropriate. Patients should be counselled on the signs and symptoms of ICANS and that the onset of events may be delayed. Patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Tepkinly should be delayed or discontinued as recommended.
Serious infections
Treatment with Tepkinly may lead to an increased risk of infections. Serious or fatal infections were observed in patients treated with Tepkinly in clinical studies. Administration of Tepkinly should be avoided in patients with clinically significant active systemic infections. As appropriate, prophylactic antimicrobials should be administered prior to and during treatment with Tepkinly. Patients should be monitored for signs and symptoms of infection, before and after Tepkinly administration, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.
Hypogammaglobulinaemia has also been reported in patients receiving Tepkinly. Immunoglobulin (Ig) levels should be monitored prior to and during treatment. Patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis.
Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported in patients treated with Tepkinly who have also received prior treatment with other immunosuppressive medications. If neurological symptoms suggestive of PML occur during Tepkinly therapy, treatment with Tepkinly should be discontinued and appropriate diagnostic measures initiated.
Tumour Lysis Syndrome (TLS)
TLS has been reported in patients receiving Tepkinly. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
Tumour flare
Tumour flare has been reported in patients treated with Tepkinly. Manifestations could include localized pain and swelling. Consistent with the mechanism of action of Tepkinly, tumour flare is likely due to the influx of T-cells into tumour sites following Tepkinly administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ. Patients treated with Tepkinly should be monitored and evaluated for tumour flare at critical anatomical sites.
CD20-negative disease
There are limited data available on patients with CD20-negative DLBCL and patients with CD20-negative FL treated with Tepkinly, and it is possible that patients with CD20-negative DLBCL and CD20-negative FL may have less benefit compared to patients with CD20-positive DLBCL and patients with CD20-positive FL, respectively. The potential risks and benefits associated with treatment of patients with CD20-negative DLBCL and FL with Tepkinly should be considered.
Immunisation
Live and/or live-attenuated vaccines should not be given during Tepkinly therapy. Studies have not been conducted in patients who received live vaccines.
Fertility, pregnancy and lactation
Tepkinly is not recommended during pregnancy, while breast-feeding, and in women of childbearing potential not using contraception.
Effects on ability to drive and use machines
Tepkinly has a major influence on the ability to drive and use machines. Due to the potential for ICANS, patients receiving Tepkinly are at risk of altered level of consciousness. Patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.
Undesirable effects
Summary of the safety profile
Tepkinly Monotherapy
The safety of Tepkinly was evaluated in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), FL (N=129) and FL (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of TEPKINLY. The most common adverse reactions (≥
Serious adverse reactions occurred in
Dose delays due to adverse reactions occurred in
Tepkinly in combination with lenalidomide and rituximab
The safety of Tepkinly in combination with lenalidomide and rituximab was evaluated in 243 patients with relapsed or refractory follicular lymphoma (FL) after one prior line of therapy (3-step step-up dose schedule N=133). The most common (≥
Serious adverse reactions occurred in
Dose delays due to an adverse reaction occurred in
This is not a complete summary of all safety information.
See Tepkinly® full Summary of Product Characteristics (SmPC) at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Contacts:
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1 | Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed May 2026. |
2 | Zhau Y, et al. Anthropometric indicators may explain the high incidence of follicular lymphoma in Europeans: Results from a bidirectional two-sample two-step Mendelian randomization. Volume 911, 15 June 2024, 148320. https://doi.org/10.1016/j.gene.2024.148320. |
3 | Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421 |
4 | Lymphoma Research Foundation official website. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/. Accessed May 2026. |
5 | Rivas‐Delgado, A., Magnano, L., Moreno‐Velázquez, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708 |
6 | Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. |
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