Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024
Roche will present over 40 abstracts across nine blood disorders at the 66th ASH Annual Meeting in December 2024. Key highlights include five-year data from the POLARIX study showing positive trends in overall survival for first-line DLBCL patients using Polivy combination therapy. Extended follow-up data of up to four years demonstrates long-lasting remissions for Lunsumio and Columvi in treating follicular lymphoma and DLBCL respectively.
New data for a subcutaneous formulation of Lunsumio shows promising response rates with lower cytokine release syndrome. The STARGLO study reveals comparable quality of life outcomes between treatment arms. Additional presentations include investigational combinations of Polivy with bispecific antibodies, showing potential for earlier treatment lines.
Roche presenterà oltre 40 abstract su nove disturbi ematologici al 66° Congresso Annuale ASH che si svolgerà a dicembre 2024. I punti salienti includono i dati a cinque anni dello studio POLARIX che mostrano tendenze positive nella sopravvivenza complessiva per i pazienti con DLBCL in prima linea che utilizzano la terapia combinata con Polivy. I dati di follow-up estesi fino a quattro anni dimostrano remissioni durevoli per Lunsumio e Columvi nel trattamento del linfoma follicolare e del DLBCL, rispettivamente.
Nuovi dati su una formulazione sottocutanea di Lunsumio mostrano tassi di risposta promettenti con una minore sindrome da rilascio di citochine. Lo studio STARGLO rivela risultati comparabili nella qualità della vita tra i bracci di trattamento. Ulteriori presentazioni includono combinazioni in fase sperimentale di Polivy con anticorpi bispecifici, mostrando potenziale per linee di trattamento più precoci.
Roche presentará más de 40 resúmenes sobre nueve trastornos hematológicos en la 66ª Reunión Anual de ASH en diciembre de 2024. Los aspectos destacados incluyen los datos a cinco años del estudio POLARIX, que muestran tendencias positivas en la supervivencia general para pacientes con DLBCL en primera línea que utilizan la terapia combinada con Polivy. Los datos de seguimiento prolongado de hasta cuatro años demuestran remisiones duraderas para Lunsumio y Columvi en el tratamiento del linfoma folicular y DLBCL, respectivamente.
Nuevos datos sobre una formulación subcutánea de Lunsumio muestran tasas de respuesta prometedoras con un menor síndrome de liberación de citoquinas. El estudio STARGLO revela resultados comparables en la calidad de vida entre los grupos de tratamiento. Presentaciones adicionales incluyen combinaciones experimentales de Polivy con anticuerpos biespecíficos, mostrando un potencial para líneas de tratamiento más tempranas.
로슈는 2024년 12월에 열리는 66회 ASH 연례 회의에서 아홉 가지 혈액 질환에 대한 40개 이상의 초록을 발표할 예정입니다. 주요 하이라이트로는 POLARIX 연구의 5년 데이터를 통해 Polivy 병용 요법을 사용하는 1차 DLBCL 환자의 전체 생존율이 긍정적인 추세를 보인다는 점이 있습니다. 최대 4년간의 연장된 추적 데이터는 각각 여포 림프종 및 DLBCL 치료에 대한 Lunsumio와 Columvi의 지속적인 완화를 보여줍니다.
Lunsumio의 피하 제형에 대한 새로운 데이터는 사이토카인 방출 증후군이 적은 유망한 반응률을 보여줍니다. STARGLO 연구는 치료 군 간의 유사한 삶의 질 결과를 나타냅니다. 추가 발표로는 Polivy와 이중 특이성 항체의 실험적 조합이 포함되어 있어 조기 치료 라인에 대한 잠재력을 보여줍니다.
Roche présentera plus de 40 résumés sur neuf troubles sanguins lors du 66e Congrès Annuel de l'ASH en décembre 2024. Parmi les points forts, on trouve les données sur cinq ans de l'étude POLARIX, montrant des tendances positives dans la survie globale des patients atteints de DLBCL en première ligne, utilisant la thérapie combinée à Polivy. Des données de suivi prolongées allant jusqu'à quatre ans démontrent des rémissions durables pour Lunsumio et Columvi dans le traitement du lymphome folliculaire et du DLBCL, respectivement.
De nouvelles données sur une formulation sous-cutanée de Lunsumio montrent des taux de réponse prometteurs avec un syndrome de libération de cytokines réduit. L'étude STARGLO révèle des résultats similaires sur la qualité de vie entre les bras de traitement. Des présentations supplémentaires incluent des combinaisons expérimentales de Polivy avec des anticorps bispécifiques, montrant un potentiel pour des lignes de traitement plus précoces.
Roche wird auf dem 66. ASH-Jahrestreffen im Dezember 2024 über 40 Abstracts zu neun Blutkrankheiten vorstellen. Zu den wichtigsten Highlights gehören die fünfjährigen Daten der POLARIX-Studie, die positive Trends in der Gesamtüberlebensrate bei DLBCL-Patienten in der Erstlinie zeigen, die eine Kombinationstherapie mit Polivy erhalten. Erweiterte Follow-up-Daten von bis zu vier Jahren zeigen langanhaltende Remissionen für Lunsumio und Columvi bei der Behandlung von follikulärem Lymphom und DLBCL.
Neue Daten zu einer subkutanen Formulierung von Lunsumio zeigen vielversprechende Ansprechraten mit geringeren Zytokinfreisetzungssyndromen. Die STARGLO-Studie zeigt vergleichbare Lebensqualitäts Ergebnisse zwischen den Behandlungsarmen. Weitere Präsentationen umfassen experimentelle Kombinationen von Polivy mit bispezifischen Antikörpern, die Potenzial für frühere Behandlungslinien zeigen.
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Basel, 05 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US. The data underscore Roche’s commitment to advance patient outcomes in lymphoma with long-term follow-up of its approved medicines Polivy® (polatuzumab vedotin), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab) as well as new investigational combination data.
Key presentations include:
- Five-year data from the phase III POLARIX study (abstract #469) reinforce the potential of Polivy in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions and for the first time show a positive trend in overall survival (OS) for people with first-line diffuse large B-cell lymphoma (DLBCL), an area that previously had little advancement in nearly two decades.1
- Extended follow-up data of up to four years from the pivotal GO29781 study of Lunsumio (abstract #4407) and NP30179 study of Columvi (abstract #865) show long-lasting remissions and immune system recovery after the end of treatment, supporting the use of fixed-duration bispecific antibodies for third line or later (3L+) follicular lymphoma (FL) and DLBCL respectively.2,3
- First presentation of data for a subcutaneous formulation of Lunsumio monotherapy from the pivotal phase II GO29781 study (abstract #1645) show high rates of deep and durable responses and low rates and severity of cytokine release syndrome in people with 3L+ FL.4 Subcutaneously administered Lunsumio could further improve the patient experience by combining shorter administration time with the existing benefits of a fixed-duration and outpatient therapy.
- New patient-reported outcomes data from the phase III STARGLO study (abstract #5132) indicate comparable health-related quality of life between treatment arms, despite higher median number of cycles received with the Columvi combination (11 versus 4).5 Together with the significant improvement in OS observed in the study, these data support the potential benefit for patients with second-line or later DLBCL.
- New and updated data from investigational study combinations of Polivy with bispecific antibodies Lunsumio and Columvi in relapsed or refractory DLBCL, including the phase Ib/II NP39488 (abstract #988) and phase II GO40516 (abstract #989) studies, add to the growing body of evidence demonstrating the potential of novel bispecific antibody/Polivy combinations in earlier treatment lines, and support their ongoing phase III development.6,7
Overview of key presentations featuring Roche medicines
| Medicine | Abstract title | Abstract number/presentation details |
| Polivy® (polatuzumab vedotin) | Five-Year Analysis of the POLARIX Study: Prolonged Follow-up Confirms Positive Impact of Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) on Outcomes | #469 oral presentation Session: 626. Aggressive Lymphomas: Clinical and Epidemiological: CARs, Bispecifics, and ADCs: Progress and Challenges in Aggressive B Cell Lymphoma Sunday 8 December 2024 9.30am PST |
| A Multicenter, Prospective, Observational Study of Pola-R-CHP in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (POLASTAR): A Preliminary Analysis | #4475 poster presentation Session: 626. Aggressive Lymphomas: Clinical and Epidemiological: Poster III Monday 9 December 2024 6pm-8pm PST | |
| Lunsumio® (mosunetuzumab) | A Randomized Phase II Study of Mosunetuzumab SC Plus Polatuzumab Vedotin Demonstrates Improved Outcomes Versus Rituximab Plus Polatuzumab Vedotin in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) | #989 oral presentation Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas Monday 9 December 2024 5.30pm PST |
| Subcutaneous Mosunetuzumab Leads to High Rates of Durable Responses, Low Rates of Cytokine Release Syndrome, and Non-Inferior Exposure Compared with Intravenous Administration in Patients with Relapsed/Refractory Follicular Lymphoma: Primary Analysis of a Pivotal Phase II Study | #1645 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I Saturday 7 December 2024 5.30pm-7.30pm PST | |
| Mosunetuzumab Continues to Demonstrate Clinically Meaningful Outcomes in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies Including Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase II Study | #4407 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III Monday 9 December 2024 6pm-8pm PST | |
| Mosunetuzumab Monotherapy Demonstrates Encouraging Activity and a Manageable Safety Profile in Patients with Heavily Pre-Treated Relapsed or Refractory Mantle Cell Lymphoma | #1646 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I Saturday 7 December 2024 5.30pm-7.30pm PST | |
| Fixed-Duration Subcutaneous Mosunetuzumab is Active and has a Manageable Safety Profile in Patients with Previously Untreated, Low-Tumor Burden Follicular Lymphoma: Updated Results from the Phase II MorningSun Study | #3008 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Sunday 8 December 2024 6pm-8pm PST | |
| Travel Burden and Travel Costs of Bispecific Antibodies in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma | #782 oral presentation Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: For a Better Tomorrow - Improving Access to Blood Cancer Treatments and Trials Monday 9 December 2024 10.45am PST | |
| Columvi® (glofitamab) | Fixed-duration Glofitamab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed or Refractory Large B-Cell Lymphoma: 3-year Follow-Up From a Pivotal Phase II Study | #865 oral presentation Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: New R-CHOP Combinations for Treatment Naïve DLBCL Sunday 8 December 2024 Midday PST |
| Glofitamab in Combination with Polatuzumab Vedotin Maintains Durable Responses and a Manageable Safety Profile in Patients with Heavily Pre-treated Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Including High-Grade B-Cell Lymphoma (HGBCL): Extended Follow-Up of a Phase Ib/II Study | #988 oral presentation Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas Monday 9 December 2024 5.15pm PST | |
| Glofitamab in Combination with Rituximab plus Ifosfamide, Carboplatin, and Etoposide shows Favorable Efficacy and Manageable Safety in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, Eligible for Stem Cell Transplant or Chimeric Antigen Receptor T-cell Therapy: Results from a Phase Ib Study | #987 oral presentation Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas Monday 9 December 2024 5pm PST | |
| Primary Results of Patient-Reported Outcomes in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated with Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) Versus Rituximab plus GemOx (R-GemOx) from the Phase III STARGLO Study | #5132 poster presentation Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III Monday 9 December 2024 6pm-8pm PST | |
| Glofitamab Induces High Response Rates and Durable Remissions in Patients (Pts) with Heavily Pretreated Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL), including those with a Poor Prognosis: Subgroup Results from a Phase I/II Study | #1631 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I Saturday 7 December 2024 5.30pm-7.30pm PST | |
| A Healthcare Utilization Model Comparing Time Toxicity Between Glofitamab and Epcoritamab Treatment Regimens | #3647 poster presentation Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster II Sunday 8 December 2024 6pm-8pm PST | |
| Englumafusp alfa | Englumafusp alfa (CD19-4-1BBL) combined with glofitamab is safe and efficacious in patients with r/r B-NHL: extended follow up analysis of the dose-escalation part of Phase 1 trial BP41072 | #990 oral presentation Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas Monday 9 December 2024 5.45pm PST |
| Cevostamab | Cevostamab in Patients with Heavily Pretreated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I Study Demonstrate Clinically Meaningful Activity and Manageable Safety and Inform the Doses and Regimen for Combination Studies | #1021 oral presentation Session: 654. Multiple Myeloma: Pharmacologic Therapies: Into the Future: New Drugs and Combinations in Multiple Myeloma Monday 9 December 2024 4.30pm PST |
| Venclexta®/Venclyxto® (venetoclax)* | CRISTALLO: Results from a Phase III Trial of Venetoclax–Obinutuzumab versus Fludarabine, Cyclophosphamide and Rituximab or Bendamustine–Rituximab in Patients with Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutations | #3237 poster presentation Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Sunday 8 December 2024 6pm-8pm PST |
| P-CD19CD20-ALLO1 (in collaboration with Poseida Therapeutics) | P-CD19CD20-ALLO1: Potent Fully Allogeneic CAR-T Therapy Targeting CD19 and CD20 with Superior Efficacy Over Single-Target Products | #4805 poster presentation Session: 702. CAR-T Cell Therapies: Basic and Translational: Poster III Monday 9 December 2024 6pm-8pm PST |
| P-BCMA-ALLO1 (in collaboration with Poseida Therapeutics) | A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM): Results from Optimized Lymphodepletion Cohort | #4828 poster presentation Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III Monday 9 December 2024 6pm-8pm PST |
| Hemlibra® (emicizumab) | Bleed Patterns in Infants, From Birth to 12 Months of Age, with Hemophilia A Treated with Emicizumab: Exploratory Analysis of the HAVEN 7 Study | #1214 poster presentation Session: 322. Hemophilia A and B: Clinical and Epidemiological: Poster I Saturday 7 December 2024 5.30pm-7.30pm PST |
| Real-World Experience With Emicizumab for Hemophilia A From the Physician Perspective Based on Survey Data | #5078 poster presentation Session: 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster III Monday 9 December 2024 6pm-8pm PST | |
| PiaSky® (crovalimab) | Phase III Randomized COMMODORE 2 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Naive to Complement Inhibition | #2687 poster presentation Session: 508. Bone Marrow Failure: Acquired: Poster II Sunday 8 December 2024 6pm-8pm PST |
| Phase III COMMODORE 1 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Switched from Ravulizumab | #4078 poster presentation Session: 508. Bone Marrow Failure: Acquired: Poster III Monday 9 December 2024 6pm-8pm PST |
*Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.
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] Salles G, et al. Five-Year Analysis of the POLARIX Study: Prolonged Follow-up Confirms Positive Impact of Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) on Outcomes. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #469.
[2] Shadman M, et al. Mosunetuzumab Continues to Demonstrate Clinically Meaningful Outcomes in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies Including Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase II Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #4407.
[3] Dickinson M, et al. Fixed-duration Glofitamab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed or Refractory Large B-Cell Lymphoma: 3-year Follow-Up From a Pivotal Phase II Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #865.
[4] Bartlett N, et al. Subcutaneous Mosunetuzumab Leads to High Rates of Durable Responses, Low Rates of Cytokine Release Syndrome, and Non-Inferior Exposure Compared with Intravenous Administration in Patients with Relapsed/Refractory Follicular Lymphoma: Primary Analysis of a Pivotal Phase II Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #1645.
[5] Gregory G, et al. Primary Results of Patient-Reported Outcomes in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated with Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) Versus Rituximab plus GemOx (R-GemOx) from the Phase III STARGLO Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #5132.
[6] Hutchings M, et al. Glofitamab in Combination with Polatuzumab Vedotin Maintains Durable Responses and a Manageable Safety Profile in Patients with Heavily Pre-treated Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Including High-Grade B-Cell Lymphoma (HGBCL): Extended Follow-Up of a Phase Ib/II Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #988.
[7] Chavez J, et al. A Randomized Phase II Study of Mosunetuzumab SC Plus Polatuzumab Vedotin Demonstrates Improved Outcomes Versus Rituximab Plus Polatuzumab Vedotin in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL). Presented at: ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #989.
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FAQ
What are the key findings from Roche's POLARIX study for DLBCL treatment (RHHBY)?
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