European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
Roche (RHHBY) has received European Commission approval for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.
The approval is based on the Phase III STARGLO study results, which showed that the Columvi combination demonstrated a 41% reduction in death risk compared to MabThera/Rituxan plus chemotherapy. The study revealed a median overall survival of 25.5 months for the Columvi combination versus 12.9 months for R-GemOx, with more than twice as many patients experiencing complete response (58.5% vs 25.3%).
This marks Columvi as the first bispecific antibody regimen available in Europe for DLBCL patients whose cancer has returned or didn't respond to initial treatment. The treatment offers an 'off-the-shelf' option with fixed duration, allowing immediate availability and a defined treatment endpoint.
Roche (RHHBY) ha ricevuto l'approvazione della Commissione Europea per Columvi in combinazione con gemcitabina e oxaliplatino (GemOx) per il trattamento di pazienti adulti con linfoma diffuso a grandi cellule B (DLBCL) recidivante o refrattario che non sono idonei a un trapianto autologo di cellule staminali.
L'approvazione si basa sui risultati dello studio di Fase III STARGLO, che ha dimostrato che la combinazione di Columvi ha mostrato una riduzione del 41% del rischio di morte rispetto a MabThera/Rituxan più chemioterapia. Lo studio ha rivelato una sopravvivenza globale mediana di 25,5 mesi per la combinazione di Columvi rispetto a 12,9 mesi per R-GemOx, con più del doppio dei pazienti che hanno mostrato una risposta completa (58,5% contro 25,3%).
Questo segna Columvi come il primo regime di anticorpi bispecifici disponibile in Europa per i pazienti DLBCL il cui cancro è tornato o non ha risposto al trattamento iniziale. Il trattamento offre un'opzione 'pronta all'uso' con durata fissa, consentendo disponibilità immediata e un termine di trattamento definito.
Roche (RHHBY) ha recibido la aprobación de la Comisión Europea para Columvi en combinación con gemcitabina y oxaliplatino (GemOx) para tratar a pacientes adultos con linfoma difuso de células B grandes (DLBCL) en recaída o refractario que no son elegibles para un trasplante autólogo de células madre.
La aprobación se basa en los resultados del estudio de Fase III STARGLO, que mostró que la combinación de Columvi demostró una reducción del 41% en el riesgo de muerte en comparación con MabThera/Rituxan más quimioterapia. El estudio reveló una supervivencia global mediana de 25.5 meses para la combinación de Columvi frente a 12.9 meses para R-GemOx, con más del doble de pacientes experimentando una respuesta completa (58.5% frente a 25.3%).
Esto marca a Columvi como el primer régimen de anticuerpo bispecífico disponible en Europa para pacientes con DLBCL cuyo cáncer ha regresado o no ha respondido al tratamiento inicial. El tratamiento ofrece una opción 'lista para usar' con duración fija, permitiendo disponibilidad inmediata y un punto final de tratamiento definido.
로슈 (RHHBY)는 자가 조혈모세포 이식이 불가능한 성인 환자의 재발성 또는 불응성 미만성 대세포 B 림프종(DLBCL) 치료를 위해 Columvi와 gemcitabine 및 oxaliplatin (GemOx) 조합에 대한 유럽연합의 승인을 받았습니다.
이번 승인은 사망 위험 41% 감소를 보여준 3상 STARGLO 연구 결과를 기반으로 하고 있습니다. 연구 결과, Columvi 조합의 중앙 전체 생존 기간은 25.5개월로 R-GemOx의 12.9개월에 비해 더 높은 수치를 보였으며, 완전 반응을 경험한 환자는 두 배 이상 많았습니다 (58.5% 대 25.3%).
이는 Columvi가 초기 치료에 반응하지 않거나 재발한 DLBCL 환자에게 유럽에서 사용할 수 있는 최초의 이중 특이 항체 요법으로 자리매김하게 됩니다. 이 치료는 즉시 사용 가능하고 정의된 치료 종료점을 제공하는 '즉시 사용 가능' 옵션을 제공합니다.
Roche (RHHBY) a reçu l'approbation de la Commission Européenne pour Columvi en combinaison avec la gemcitabine et l'oxaliplatine (GemOx) pour traiter des patients adultes atteints de lymphome diffus à grandes cellules B (DLBCL) en rechute ou réfractaire, qui ne sont pas éligibles à une greffe de cellules souches autologues.
Cette approbation est basée sur les résultats de l'étude de Phase III STARGLO, qui a montré que la combinaison Columvi a entraîné une réduction de 41% du risque de décès par rapport à MabThera/Rituxan plus chimiothérapie. L'étude a révélé une survie globale médiane de 25,5 mois pour la combinaison Columvi contre 12,9 mois pour R-GemOx, avec plus de deux fois plus de patients ayant présenté une réponse complète (58,5% contre 25,3%).
Cela marque Columvi comme le premier régime d'anticorps bispécifiques disponible en Europe pour les patients DLBCL dont le cancer est revenu ou n'a pas répondu au traitement initial. Ce traitement offre une option 'prête à l'emploi' avec une durée fixe, permettant une disponibilité immédiate et un objectif de traitement défini.
Roche (RHHBY) hat die Genehmigung der Europäischen Kommission für Columvi in Kombination mit Gemcitabin und Oxaliplatin (GemOx) zur Behandlung von erwachsenen Patienten mit rezidiviertem oder refraktärem diffusen großzelligen B-Zell-Lymphom (DLBCL) erhalten, die nicht für eine autologe Stammzelltransplantation geeignet sind.
Die Genehmigung basiert auf den Ergebnissen der Phase-III-Studie STARGLO, die zeigte, dass die Kombination von Columvi eine 41%ige Reduktion des Sterberisikos im Vergleich zu MabThera/Rituxan plus Chemotherapie aufwies. Die Studie ergab eine mediane Gesamtüberlebenszeit von 25,5 Monaten für die Columvi-Kombination im Vergleich zu 12,9 Monaten für R-GemOx, wobei mehr als doppelt so viele Patienten eine vollständige Ansprechrate hatten (58,5% gegenüber 25,3%).
Dies markiert Columvi als das erste bispezifische Antikörperregime, das in Europa für DLBCL-Patienten verfügbar ist, deren Krebs zurückgekehrt ist oder nicht auf die Erstbehandlung angesprochen hat. Die Behandlung bietet eine 'sofort einsatzbereite' Option mit fester Dauer, die sofortige Verfügbarkeit und einen definierten Behandlungszeitpunkt ermöglicht.
- 41% reduction in death risk compared to standard treatment
- Nearly doubled median overall survival (25.5 vs 12.9 months)
- More than doubled complete response rate (58.5% vs 25.3%)
- First bispecific antibody approval in this treatment setting
- Immediate availability as off-the-shelf treatment
- None.
- Approval based on Phase III STARGLO study where Columvi in combination with chemotherapy showed a
41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy1,2 - DLBCL is an aggressive cancer with a high risk of progression meaning urgent and effective treatments are needed for people who relapse or have refractory disease
- This Columvi regimen offers a much needed off-the-shelf and fixed-duration treatment option for those ineligible for transplant
Basel, 14 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment. In July 2023, Columvi received a conditional marketing authorisation to treat people with R/R DLBCL after two or more lines of systemic therapy. In addition to today’s approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled.
“Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.”
“People with R/R DLBCL not eligible for ASCT represent a challenging population, especially those with primary refractory disease or early relapse whose need for a readily accessible and effective therapy is insufficiently addressed globally,” said Franck Morschhauser, MD, PhD, Professor of Haematology, University Hospital Lille and STARGLO study investigator. “This new Columvi combination is immediately available if a patient’s cancer returns or doesn’t respond to first-line therapy, which is a welcome addition to manage DLBCL.”
Approval is based on results from the pivotal phase III STARGLO study, where Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera®/Rituxan® (rituximab) and GemOx (R-GemOx) in people with R/R DLBCL.1,2 In the primary analysis (conducted after a median follow-up of 11.3 months), there was a
DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. In Europe, an estimated 38,000 people are diagnosed with DLBCL each year.3,4 Approximately four out of ten DLBCL patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.5,6
Whilst second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that can control the disease and improve survival.7 Columvi in combination with GemOx offers an ‘’off-the-shelf’’ treatment regimen, readily available for infusion in any setting, meaning patients can avoid delays in starting their next treatment. Columvi is also designed to be given for a fixed period offering a target end date for people’s course of therapy and the possibility of a treatment-free period after completion.
Columvi, along with Lunsumio® (mosunetuzumab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Roche aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems.
About the STARGLO study
The STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.
About Columvi® (glofitamab)
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma.
As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080].
About diffuse large B-cell lymphoma (DLBCL)
DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.3 Approximately 160,000 people worldwide are diagnosed with DLBCL each year.3,8 While it is generally responsive to treatment in the frontline, as many as
About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] Abramson J, et al. Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results of a Global Randomized Phase III trial (STARGLO). Presented at: EHA Hybrid Congress; 2024 Jun 3-16. Abstract #LB3438.
[2] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404 (10466): 1940-1954.
[3] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited 2025 April]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.
[4] World Health Organization. Numbers derived from GLOBOCAN 2022. Europe Factsheet [Internet; cited 2025 April]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf.
[5] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073.
[6] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858.
[7] Fabbri N, Mussetti A and Sureda A. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312.
[8] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited 2025 April]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.
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