ICML 2017: 3-Year Follow-up Showed Fourfold Progression-Free Survival Benefit With Ibrutinib vs Temsirolimus at First Relapse in Mantle Cell Lymphoma

Key Points

  • Results demonstrated that the subset of patients treated with ibrutinib at first relapse after one prior line of therapy achieved a median progression-free survival of more than 2 years (25.4 months). This was fourfold longer than treatment with temsirolimus (6.2 months).
  • In the overall study patient population, which included patients who had received more than one prior line of therapy (median two prior therapies), median progression-free survival was also significantly increased in patients treated with ibrutinib vs temsirolimus (15.6 vs 6.2 months).
  • Ibrutinib tended to increase overall survival, with a median overall survival with ibrutinib of 30.3, compared with 23.5 months with temsirolimus.

Three-year follow-up data from the phase III RAY study in patients with relapsed or refractory mantle cell lymphoma were presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. These results demonstrated that the subset of patients treated with ibrutinib (Imbruvica) at first relapse after 1 prior line of therapy achieved a median progression-free survival of more than 2 years (25.4 months). This was fourfold longer than treatment with temsirolimus (Torisel; 6.2 months [hazard ratio [HR] = 0.40; 95% confidence interval [CI] = 0.25–0.64]). Data showed a median overall survival of 3.5 years with ibrutinib after 1 prior line of therapy (42.1 months with ibrutinib vs 27.0 months with temsirolimus [HR = 0.74; 95% CI = 0.43–1.30]).

More Findings

In the overall study patient population, which included patients who had received more than one prior line of therapy (median, two prior therapies), median progression-free survival was also significantly increased in patients treated with ibrutinib vs temsirolimus (15.6 vs 6.2 months [HR = 0.45; 95% CI = 0.35­–0.60; P < .0001]). In addition, ibrutinib tended to increase overall survival, with a median overall survival with ibrutinib of 30.3 vs 23.5 months with temsirolimus (HR = 0.74; 95% CI = 0.54–1.02; P = .0621).

“The data from this long-term follow-up further highlight the potential of ibrutinib for patients with mantle cell lymphoma, especially if used at first relapse,” said Simon Rule, MD, Professor of Clinical Haematology at Plymouth University, Peninsula Schools of Medicine & Dentistry.

Complete response was achieved in nearly a quarter (23.0%) of all patients who received ibrutinib. The complete response rate in patients who had received one line of therapy prior to ibrutinib (33.3%) was more than double that achieved in patients who had received more than one line of therapy prior to ibrutinib (15.9%). The duration of response in all patients who achieved a complete response with ibrutinib was almost 3 years (35.6 months).

Safety and Adverse Events

The safety profile was consistent with primary analysis and known safety data on ibrutinib. No new safety signals for ibrutinib were observed in the trial.

Overall frequencies of adverse events were similar or lower in the ibrutinib arm, even with longer treatment exposure. Nearly twice as many patients discontinued temsirolimus due to adverse events vs ibrutinib (31.7% vs 17.3%). In addition, exposure-adjusted rates of atrial fibrillation were similar between the two groups (0.392 vs 0.331 with ibrutinib and temsirolimus, respectively) and exposure-adjusted bleeding rates were lower with ibrutinib vs temsirolimus (2.880 vs 6.683). In the ibrutinib arm, grade ≥ 3 adverse events included thrombocytopenia, anemia, and neutropenia in 9.4%, 8.6%, and 12.9% of patients, respectively.

“We are encouraged by these long-term data which demonstrated the efficacy and safety of ibrutinib after one prior line of therapy in patients with previously treated mantle cell lymphoma. These data add to the growing body of evidence which shows that using ibrutinib earlier in the treatment pathway may have significant benefits for patients,” said Catherine Taylor, MD, Hematology Therapeutic Area Lead, Janssen Europe, Middle East, and Africa. “We are committed to addressing critical unmet need in B-cell malignancies such as mantle cell lymphoma, which has traditionally had poor outcomes, and are aiming to make this a more manageable disease for patients in the future.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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