Real World Study Highlights Poor OS in Relapsed/Refractory MCL After BTK Inhibitor Failure

Real World Study Highlights Poor OS in Relapsed/Refractory MCL After BTK Inhibitor Failure

Real-world results from the retrospective SCHOLAR-2 study provided a benchmark for survival in patients with relapsed or recurrent refractory mantle cell lymphoma who received salvage therapy after failure of initial tyrosine kinase inhibitor therapy of Bruton.

Real-world data highlighted that patients with relapsed or refractory mantle cell lymphoma (MCL) in whom Bruton’s tyrosine kinase (BTK) inhibitors had failed experienced worse overall survival (OS), and provided a benchmark for survival among those who received salvage therapy after initial salvage therapy. treatment failure or discontinuation, according to the findings of the retrospective chart review of the SCHOLAR-2 trial.

Of the 240 patients included in the analysis, the median OS in the overall cohort after initiation of first BTK inhibitor therapy was 14.6 months (95% CI, 11.6-20.0). In addition, the median OS was 23.8 months (95% CI, 18.9-30.1) among 149 patients who received salvage therapy after initial BTK inhibitor use and 5.5 months (95% CI, 95%, 3.9-8.2) for 91 patients who received no further therapy. The 1-year OS estimates after BTK inhibitor use for patients who received follow-up therapy and those who did not, respectively, were 69.1% and 34.4%, and the 2-year OS estimates they were 50.0% and 17.2%.

The SCHOLAR-2 international observational study reviewed cases of patients aged 18 years and older with relapsed or refractory MCL whose disease progressed after initial BTK inhibitor therapy or who discontinued treatment due to intolerance between July 2012 and July 2018. Patients were enrolled at eligible treatment centers. had inpatient diagnostic and treatment facilities for B-cell lymphomas, belonged to a network of oncologists/hematologists treating patients with B-cell lymphomas, had been in business while treating patients for at least 24 months, and had records Clinicians available for review.

Among the 282 patients screened with relapsed or refractory MCL, 240 met the study eligibility criteria of having received prior BTK inhibitor therapy. Of these patients, 149 received salvage therapy and 91 received no further treatment after initial use of the BTK inhibitor.

The primary outcome of the study was OS. Secondary outcomes included patient demographics, disease characteristics, and treatment patterns among the patient population.

The median age of 226 patients at the time of initial diagnosis of MCL was 68 years (range, 39-92). The majority of patients were male (74.8%) and had stage IV disease (81.5%). In addition, the majority had an ECOG performance status of 0 or 1 (88.3%), bone marrow involvement (72.6%), and overexpression of t(11;14) or cyclin D1 (92.2%). In addition, 25.2% of the patients had blastoid morphology, 28.5% had the presence of B symptoms, 8.4% had bulky disease, 44.1% had splenic involvement, and 27.4% had disease. extranodal.

At the start of the first post-BTK inhibitor period among 149 patients, 35.2% had an ECOG performance status of 2 or higher, 37.0% had blastoid morphology, and 19.0% had bulky disease. Additionally, 70.3% of patients had stage IV disease and 45.0% had bone marrow involvement. Patients in this group received a median of 3 prior lines of treatment (range, 1-11). Overall, 2.7% of patients received 1 prior line of therapy, 34.9% received 2, 29.5% received 3, and 32.9% received 4 or more. Patients received BTK inhibitor therapy for a median of 7.1 months.

Most patients received treatment with at least 1 BTK inhibitor regimen (93.8%), although a smaller portion received 2 lines (5.8%) and 3 lines (0.4%). In addition, 1.7% of patients received their first BTK inhibitor in first line, 35.4% received it in second line, 28.3% in third line, 16.7% in fourth line, 12.1% in the fifth line and 5.8% in a subsequent line. Early BTK inhibitor regimens often included ibrutinib (Imbruvica) alone (87.1%) or in combination with other agents (10.4%). Additionally, 2.5% of patients received single-agent acalabrutinib (Calquence). A total of 37.9% of patients received no further treatment after BTK inhibitor therapy. Of the other 149 patients who received additional systemic antilymphoma therapy, 61.7% received 1 line of therapy, 16.8% received 2 lines of therapy, and 14.8% received 3 lines.

The most common first post-BTK inhibitor treatment was chemotherapy, which was administered to 52.3% of patients with or without antibodies; the most common chemotherapy agents included bendamustine (Treanda) and rituximab (Rituxan) in 15.8%, cytarabine-based regimens in 10.7%, or other agents in 14.8%. A total of 45.0% received targeted therapies with or without antibodies after their first BTK inhibitor, including lenalidomide (Revlimid)-containing regimens in 17.4% of patients, bortezomib-containing regimens in 8.7% and other targeted therapies in 12.8%. In addition, 2.7% of patients received radiotherapy as their first post-BTK inhibitor therapy.


Hess G, Dreyling M, Oberic L, et al. Real-world experience among patients with relapsed/refractory mantle cell lymphoma after Bruton’s tyrosine kinase inhibitor failure in Europe: the SCHOLAR-2 retrospective chart review study. Br J Haematol. Published online October 18, 2022. doi:10.1111/bjh.18519

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