CHMP recommends EU approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Roche has received a CHMP recommendation for EU approval of Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients ineligible for autologous stem cell transplant.
The recommendation is based on the phase III STARGLO study results, which demonstrated a 41% reduction in death risk compared to rituximab and GemOx. If approved, this combination will become the first bispecific antibody regimen available for DLBCL patients post-relapse.
DLBCL affects approximately 38,000 Europeans annually, with 40% of patients relapsing after initial treatment. The Columvi combination offers an off-the-shelf, fixed-duration treatment option that can be initiated immediately after cancer returns, addressing a significant unmet need in DLBCL treatment.
Roche ha ricevuto una raccomandazione dal CHMP per l'approvazione nell'UE di Columvi (glofitamab) in combinazione con gemcitabina e oxaliplatino (GemOx) per il trattamento di pazienti con linfoma diffuso a grandi cellule B (DLBCL) in recidiva o refrattari, non idonei per il trapianto di cellule staminali autologhe.
La raccomandazione si basa sui risultati dello studio di fase III STARGLO, che ha dimostrato una riduzione del 41% del rischio di morte rispetto a rituximab e GemOx. Se approvata, questa combinazione diventerà il primo regime di anticorpi bispecifici disponibile per i pazienti DLBCL dopo la recidiva.
Il DLBCL colpisce circa 38.000 europei ogni anno, con il 40% dei pazienti che recidiva dopo il trattamento iniziale. La combinazione Columvi offre un'opzione di trattamento pronta all'uso e a durata fissa che può essere avviata immediatamente dopo il ritorno del cancro, rispondendo a un'esigenza significativa non soddisfatta nel trattamento del DLBCL.
Roche ha recibido una recomendación del CHMP para la aprobación en la UE de Columvi (glofitamab) en combinación con gemcitabina y oxaliplatino (GemOx) para el tratamiento de pacientes con linfoma difuso de células B grandes (DLBCL) en recaída o refractarios, no elegibles para trasplante de células madre autólogas.
La recomendación se basa en los resultados del estudio de fase III STARGLO, que demostró una reducción del 41% en el riesgo de muerte en comparación con rituximab y GemOx. Si se aprueba, esta combinación se convertirá en el primer régimen de anticuerpos bispecíficos disponible para pacientes DLBCL tras la recaída.
El DLBCL afecta a aproximadamente 38,000 europeos anualmente, con un 40% de los pacientes que recaen después del tratamiento inicial. La combinación Columvi ofrece una opción de tratamiento lista para usar y de duración fija que puede iniciarse inmediatamente después de que el cáncer regrese, abordando una necesidad significativa no satisfecha en el tratamiento del DLBCL.
로슈는 자가 조혈모세포 이식이 불가능한 재발성 또는 불응성 미만성 대세포 B 림프종(DLBCL) 환자를 치료하기 위해 콜룸비 (글로피타맙)를 젬시타빈 및 옥살리플라틴(GemOx)과 병용하여 EU 승인을 위한 CHMP의 추천을 받았습니다.
이 추천은 rituximab 및 GemOx와 비교하여 사망 위험을 41% 감소시킨 3상 STARGLO 연구 결과를 기반으로 하고 있습니다. 승인될 경우, 이 조합은 재발 후 DLBCL 환자를 위한 최초의 이중 특이성 항체 요법이 될 것입니다.
DLBCL은 매년 약 38,000명의 유럽인을 영향을 미치며, 초기 치료 후 40%의 환자가 재발합니다. 콜룸비 조합은 암이 재발한 후 즉시 시작할 수 있는 즉시 사용 가능한 고정 기간 치료 옵션을 제공하여 DLBCL 치료에서 충족되지 않은 중요한 필요를 해결합니다.
Roche a reçu une recommandation du CHMP pour l'approbation de l'UE de Columvi (glofitamab) en association avec la gemcitabine et l'oxaliplatine (GemOx) pour le traitement des patients atteints de lymphome diffus à grandes cellules B (DLBCL) en rechute ou réfractaires, non éligibles pour une transplantation de cellules souches autologues.
La recommandation est basée sur les résultats de l'étude de phase III STARGLO, qui a démontré une réduction de 41 % du risque de décès par rapport au rituximab et au GemOx. Si elle est approuvée, cette combinaison deviendra le premier schéma d'anticorps bispécifiques disponible pour les patients DLBCL après une rechute.
Le DLBCL touche environ 38 000 Européens chaque année, avec 40 % des patients en rechute après le traitement initial. La combinaison Columvi offre une option de traitement prête à l'emploi et de durée fixe qui peut être initiée immédiatement après le retour du cancer, répondant ainsi à un besoin non satisfait important dans le traitement du DLBCL.
Roche hat eine CHMP-Empfehlung für die EU-Zulassung von Columvi (glofitamab) in Kombination mit Gemcitabin und Oxaliplatin (GemOx) zur Behandlung von Patienten mit rezidiviertem oder refraktärem diffus großzelligem B-Zell-Lymphom (DLBCL) erhalten, die nicht für eine autologe Stammzelltransplantation geeignet sind.
Die Empfehlung basiert auf den Ergebnissen der Phase-III-Studie STARGLO, die eine 41%ige Reduktion des Sterberisikos im Vergleich zu Rituximab und GemOx zeigte. Sollte es genehmigt werden, wird diese Kombination das erste bispezifische Antikörperregime sein, das für DLBCL-Patienten nach einem Rückfall verfügbar ist.
DLBCL betrifft jährlich etwa 38.000 Europäer, wobei 40% der Patienten nach der Erstbehandlung einen Rückfall erleiden. Die Kombination Columvi bietet eine sofort einsatzbereite, zeitlich begrenzte Behandlungsoption, die sofort nach dem Rückfall des Krebses begonnen werden kann und somit einen erheblichen ungedeckten Bedarf in der DLBCL-Behandlung anspricht.
- 41% reduction in death risk demonstrated in Phase III trial
- First bispecific antibody showing improved survival in DLBCL
- Off-the-shelf availability enables immediate treatment initiation
- Addresses large market with 38,000 annual European DLBCL diagnoses
- to patients ineligible for stem cell transplant
- Pending final European Commission approval
- Treatment restricted to relapsed/refractory cases only
- Columvi plus chemotherapy showed a
41% reduction in the risk of death in the pivotal phase III STARGLO study1,2 - DLBCL—an aggressive disease with a high risk of progression—remains an area of high unmet need, especially for treatments that can be initiated soon after the cancer returns
- If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse
Basel, 28 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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). The standard second-line (2L) therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem cell transplant. New therapies have been recently introduced, however, not all patients can access or are eligible for these treatments.3 If approved, this Columvi combination could provide a much-needed, off-the-shelf treatment option. A final decision is expected from the European Commission in the near future.
DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. Each year in Europe, an estimated 38,000 people are diagnosed with DLBCL.4,5 Approximately four out of ten patients will relapse after first line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.6,7
“For patients with DLBCL who relapse after initial therapy, urgent and effective treatment is required to regain disease control,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “As the first bispecific antibody to show improved survival in DLBCL in a randomised phase III study, Columvi could offer an additional treatment option that is immediately available for patients who relapse.”
Whilst 2L 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.3 Columvi is designed to be off-the-shelf and readily available for infusion, meaning patients can avoid crucial delays in starting their next treatment.
The CHMP recommendation is based on results from the phase III STARGLO study, which were presented at the 29th European Hematology Association Congress and published in The Lancet.1,2 Data showed Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival improvement versus MabThera®/Rituxan® (rituximab) and GemOx, with a
Columvi was the first fixed-duration bispecific antibody to receive conditional marketing authorisation in the EU as a monotherapy to treat people with R/R DLBCL after two or more lines of systemic therapy based on the pivotal phase I/II NP30179 study [NCT03075696]. STARGLO was intended as a confirmatory study for the conditional marketing authorisation of Columvi in the EU.
Columvi, along with Lunsumio® (mosunetuzumab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio, with more than 7,300 patients treated with these therapies to date.8
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, cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study.
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 (R-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 (OS; primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.
In the primary analysis (conducted after a median follow-up of 11.3 months) patients treated with Columvi plus GemOx lived significantly longer, with a
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 and mantle cell lymphoma.
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.4 Approximately 160,000 people worldwide are diagnosed with DLBCL each year.4,9 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.
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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] 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.
[4] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited 2025 February]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.
[5] World Health Organization. Numbers derived from GLOBOCAN 2022. Europe Factsheet [Internet; cited 2025 February]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf
[6] 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.
[7] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858.
[8] Roche data on file.
[9] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited 2025 February]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.
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FAQ
What is the survival benefit of Columvi combination therapy for DLBCL patients (RHHBY)?
How many European patients are diagnosed with DLBCL annually that could benefit from Roche's Columvi (RHHBY)?
What makes Columvi unique in the DLBCL treatment landscape for Roche (RHHBY)?
What percentage of DLBCL patients relapse after first-line treatment who might need Columvi (RHHBY)?
