FDA accepts supplemental Biologics License Application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Roche announced FDA acceptance of a supplemental Biologics License Application (sBLA) for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients. The application is based on the phase III STARGLO study, which demonstrated significant overall survival improvement compared to standard treatment.
The FDA decision is expected by July 20, 2025. The treatment targets patients who have received at least one prior therapy and are ineligible for stem cell transplant. The study results showed Columvi combination therapy to be the first CD20xCD3 bispecific antibody demonstrating survival benefits in DLBCL in a randomized phase III trial.
Roche ha annunciato l'accettazione da parte della FDA di una richiesta supplementare di licenza biologica (sBLA) per Columvi in combinazione con gemcitabina e ossaliplatino (GemOx) per il trattamento di pazienti con linfoma diffuso a grandi cellule B (DLBCL) in recidiva o refrattari. L'applicazione si basa sullo studio STARGLO di fase III, che ha dimostrato un miglioramento significativo della sopravvivenza globale rispetto al trattamento standard.
La decisione della FDA è attesa entro il 20 luglio 2025. Il trattamento è destinato a pazienti che hanno ricevuto almeno una terapia precedente e non sono idonei per il trapianto di cellule staminali. I risultati dello studio hanno mostrato che la terapia combinata con Columvi è il primo anticorpo bispecifico CD20xCD3 a dimostrare benefici nella sopravvivenza in DLBCL in uno studio clinico randomizzato di fase III.
Roche anunció la aceptación por parte de la FDA de una solicitud suplementaria de licencia biológica (sBLA) para Columvi en combinación con gemcitabina y oxaliplatino (GemOx) para el tratamiento de pacientes con linfoma difuso de células B grandes (DLBCL) en recaída o refractarios. La solicitud se basa en el estudio STARGLO de fase III, que demostró una mejora significativa en la supervivencia general en comparación con el tratamiento estándar.
Se espera la decisión de la FDA para el 20 de julio de 2025. El tratamiento está dirigido a pacientes que han recibido al menos una terapia previa y no son elegibles para un trasplante de células madre. Los resultados del estudio mostraron que la terapia combinada con Columvi es el primer anticuerpo bispecífico CD20xCD3 que demuestra beneficios en la supervivencia en DLBCL en un ensayo clínico aleatorizado de fase III.
로슈는 콜럼비와 gemcitabine 및 oxaliplatin (GemOx)의 조합에 대한 보충 생물학적 라이선스 신청서 (sBLA)가 FDA에 의해 수용되었음을 발표했습니다. 이 신청은 표준 치료에 비해 전체 생존율 향상을 입증한 3상 STARGLO 연구에 기반합니다.
FDA의 결정은 2025년 7월 20일까지 예상됩니다. 이 치료는 최소한 하나의 이전 치료를 받은 환자와 줄기세포 이식이 불가능한 환자를 대상으로 합니다. 연구 결과는 Columvi 복합요법이 무작위 3상 시험에서 DLBCL의 생존 이점을 입증한 최초의 CD20xCD3 이으면역항체로 나타났습니다.
Roche a annoncé l'acceptation par la FDA d'une demande de licence biologique supplémentaire (sBLA) pour Columvi en combinaison avec la gemcitabine et l'oxaliplatine (GemOx) pour traiter les patients atteints d'un lymphome diffus à grandes cellules B (DLBCL) en rechute ou réfractaire. La demande est fondée sur l'
La décision de la FDA est attendue d'ici le 20 juillet 2025. Le traitement cible des patients ayant reçu au moins une thérapie antérieure et n'étant pas éligibles pour une transplantation de cellules souches. Les résultats de l'étude ont montré que la thérapie combinée avec Columvi est le premier anticorps bispécifique CD20xCD3 à démontrer des avantages en matière de survie dans le DLBCL lors d'un essai randomisé de phase III.
Roche hat die Akzeptanz einer zusätzlichen Biologischen Lizenzanwendung (sBLA) durch die FDA für Columvi in Kombination mit Gemcitabin und Oxaliplatin (GemOx) zur Behandlung von Patienten mit rezidiviertem oder refraktärem diffusem großzelligen B-Zell-Lymphom (DLBCL) bekannt gegeben. Die Anwendung basiert auf der Phase III STARGLO-Studie, die eine signifikante Verbesserung der Gesamtüberlebensrate im Vergleich zur Standardbehandlung zeigte.
Die Entscheidung der FDA wird bis zum 20. Juli 2025 erwartet. Die Therapie richtet sich an Patienten, die mindestens eine vorherige Therapie erhalten haben und nicht für eine Stammzelltransplantation geeignet sind. Die Studienergebnisse zeigten, dass die Kombinationstherapie mit Columvi der erste bispezifische Antikörper CD20xCD3 ist, der in einer randomisierten Phase-III-Studie Überlebensvorteile bei DLBCL nachweist.
- First CD20xCD3 bispecific antibody showing survival benefit in DLBCL phase III trial
- Already approved in over 50 countries for R/R DLBCL treatment
- Statistically significant improvement in overall survival versus standard treatment
- Safety profile consistent with known individual medicine profiles
- FDA approval decision pending until July 2025
- Treatment to patients ineligible for stem cell transplant
- Application is based on data from the phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival1,2
- This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression
- Improving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those who aren’t eligible for transplant3
Basel, 5 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. The FDA is expected to make a decision on approval by 20 July 2025.
The standard second-line therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem-cell transplant, however, not all patients are a candidate due to age or coexisting medical conditions. While newer therapies are becoming available, barriers remain for many and alternative treatment options are needed for these patients to improve survival outcomes.3
“For people with aggressive lymphomas like DLBCL, timely intervention with effective therapies can be crucial to reduce the risk of disease progression and improve long-term outcomes,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are encouraged by the overall survival benefit seen with this Columvi combination and hope it can become an important treatment option for those who are in need of alternative therapies.”
The sBLA is based on results from the phase III STARGLO study, which were presented at the European Hematology Association Congress earlier this year and recently published in The Lancet.1,2 Data showed Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera®/Rituxan® (rituximab) and GemOx (R-GemOx), making it the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in a randomised phase III trial.1,2 Safety of the combination appeared consistent with the known safety profiles of the individual medicines.1,2
Data from the STARGLO study have been submitted to other health authorities around the world for approval consideration, including the European Medicines Agency.
Columvi is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme, which has seen more than 3,000 patients treated in clinical trials and more than 2,600 treated in clinical practice to date.4 Columvi was the first fixed-duration bispecific antibody to receive accelerated approval by the U.S. FDA and conditional marketing authorisation in the EU as a monotherapy to treat people with R/R DLBCL after two or more lines of systemic therapy and is currently approved in more than 50 countries around the world.
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), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study.
About the STARGLO study5
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
STARGLO is intended as a confirmatory study to convert the accelerated approval of Columvi in the US and conditional marketing authorisation in the EU to full approvals for people with R/R DLBCL after two or more lines of systemic therapy based on the pivotal phase I/II NP30179 study [NCT03075696].
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 the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.6 DLBCL is an aggressive (fast-growing) type of NHL.6 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] Gisselbrecht C and Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol 2018; 182(5): 633–643.
[4] Roche data on file.
[5] ClinicalTrials.gov. A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: NCT04408638 [Internet; cited 2024 November]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04408638.
[6] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited 2024 November]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.
[7] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858.
[8] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited 2024 November]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.
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