Hematology: new combination of treatments effective in patients with mantle cell lymphoma

The final results of the SHINE study, coordinated at the French level by Pr Steven Le Gouill, were presented at the ASCO 2022 congress.
ASCO Meeting 2022

From June 3 to 7 in Chicago (United States), the world cancer community will gather for the key American Society of Clinical Oncology (ASCO) Congress. Physicians from Institut Curie across all areas of oncology will be present in full forve over five days, to share their highly promising results to speed up the fight against cancer.

On June 3, 2022, the final results from the SHINE study were presented at ASCO, demonstrating the efficacy of targeted therapy (a Bruton tyrosine kinase inhibitor) combined with immunochemotherapy in first-line treatment of patients with mantle cell lymphoma. Professor Steven Le Gouill, hematologist and director of the Institut Curie Hospital Complex and member of the SHINE steering committee coordinated this study in France while he was head of the hematology department at Nantes University Hospital, in conjunction with LYSA, a clinical research network on lymphoma. The results are published at the same time in the New England Journal of Medicine.

Key Points

  • New combination of targeted therapy + immuno-chemotherapy
  • 523 patients aged 65 years or older with mantle cell lymphoma
  • International Phase 3 study
  • 50% improvement in the duration of progression-free survival in patients who received the combination of targeted therapy and immunochemotherapy
  • Towards a change in clinical practice at international level

The SHINE trial is the first international phase 3 trial to show a positive impact of the combination of a targeted therapy, ibrutinib, in first-line treatment of mantle cell lymphoma. Our results show a very clear benefit for patients and this new treatment option calls for a change in clinical practice internationally. The next stage is to move away from chemotherapy to offer a combination of targeted therapies including Ibrutinib. The international "Oasis" study conducted by the LYSA group, for which I am the principal investigator, raises this question, said Professor Steven Le Gouill, hematologist and director of the Institut Curie hospital group.

With nearly 200,000 people diagnosed every year worldwide, including about 600 in France, mantle cell lymphoma represents 2 to 10% of lymphomas (cancer of the lymphatic system). These are non-Hodgkin's lymphomas (NHL) that affect B cells in the immune system in a region of the lymph node called the “mantle zone”. These tumors are aggressive with frequent relapses. They affect men more than women, and more frequently those over the age of 65.

For some years now, new treatments and clinical trials could change the landscape for patients. This is the case for the SHINE study, which assessed the effectiveness of a targeted therapy (ibrutinib, a Bruton’s tyrosine kinase inhibitor) combined with immuno-chemotherapy in the first-line treatment.

The treatment improves progression-free survival by 50%

The SHINE study is an international, double-blind clinical trial involving 523 patients with mantle cell lymphoma aged 65 years or older. Patients were randomly allocated into two groups: one receiving a combination of targeted therapy and immunochemotherapy (261 patients) and the other receiving the immunochemotherapy alone (262 patients). The average age of the patients in this study was 71 years.

Results: average progression-free survival - the time between the start of treatment and disease progression - was 80.6 months with the targeted therapy/immunochemotherapy combination, compared to 52.9 months for those who received the immunochemotherapy alone; a 50% improvement in older patients with newly diagnosed mantle cell lymphoma. Moreover, the complete response rate was 65.5% in the targeted therapy group and 57.6% in the placebo group. Finally, there was no difference in overall survival between the treatment groups.

The SHINE study was funded by Janssen Pharmaceuticals NV and Pharmacyclics LLC, an AbbVie company.

References :

► Primary results from the double-blind, placebo-controlled, phase III SHINE study of ibrutinib in combination with bendamustine-rituximab (BR) and R maintenance as a first-line treatment for older patients with mantle cell lymphoma (MCL). Session « Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia » – Présentation orale ASCO  le 3 juin à 20h24 (heure française)

Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma. Michael L. Wang, M.D., (…) Steven Le Gouill, M.D., Ph.D., and Martin Dreyling, M.D. 3 juin 2022. New England Journal of Medicine. DOI: 10.1056/NEJMoa2201817

Learn more about Institut Curie's promising innovations and clinical advances presented at this year's ASCO: https://curie.fr/page/asco-2022-les-innovations-et-avancees-cliniques-tres-prometteuses-de-linstitut-curie

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