Panel Discussion/References

Transcription

1 Follicular Lymphoma (FOLL) FOLL-B category designation for first-line therapy options for FL: Bendamustine + rituximab RCHOP RCVP Submission from Genentech to review the data related to obinutuzumab for previously untreated FL. FOLL-B inclusion of radioimmunotherapy (RIT) with ibritumomab tiuxetan as second-line and subsequent therapy option for FL. FOLL-B inclusion of fludarabine + rituximab as second-line and subsequent therapy option for FL. The results of the GALLIUM study (noted in the reference below) showed that obinutuzumab plus chemotherapy (bendamustine, CHOP or CVP) was associated with significantly longer progressionfree survival than rituximab used in combination with same chemotherapy regimens. However, response rates were not significantly different between the two groups and overall survival was similar in two groups. In addition, frequency of high-grade adverse events was higher with obinutuzumab than with rituximab. Therefore, the panel indicated that the data are not robust enough to designate obinutuzumab as superior to rituximab and the consensus was to list all chemoimmunotherapy regimens with category 2A recommendation. Marcus R, Davies A, Ando K, et al. Obinutuzumab for the first-line treatment of follicular lymphoma. N Engl J Med 2018;377: acknowledged that available data does support the inclusion of RIT with ibritumomab tiuxetan as a category 1 recommendation. However, the panel consensus was that it is an appropriate option for second-line and subsequent therapy with a category 2A recommendation. consensus was to remove fludarabine + rituximab as second-line and subsequent therapy option for FL due to limited clinical use inclusion of RFND (rituximab, fludarabine, mitoxantrone, dexamethasone) as second-line and subsequent therapy option for FL. consensus was to remove RFND as second-line and subsequent therapy option for FL due to limited clinical use

2 Marginal Zone Lymphoma (MZL) consider the inclusion of lenalidomide + rituximab as a first-line therapy option. was to include lenalidomide + rituximab as a first-line therapy option. This was added as a category 2B recommendation. Fowler NH, Davis RE, Rawal S, et al. Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial. Lancet Oncol 2014;15: Comment to consider the inclusion of ibritumomab tiuxetan as a first-line therapy option. Comment to reassess the inclusion of fludarabine + rituximab as a second-line treatment option for patients with MCL. reassess the inclusion of RFND (rituximab, fludarabine, mitoxantrone, dexamethasone) as a second-line treatment option for was to include ibritumomab tiuxetan as a first-line therapy option. This was added as a category 2B recommendation. Lossos IS, Fabregas JC, Koru-Sengul T, et al. Phase II study of (90)Y Ibritumomab tiuxetan in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma 2015;56: consensus was that fludarabine + rituximab should be removed as a second-line treatment option for MZL due to limited clinical use. consensus was that RFND should be removed as a second-line treatment option for MZL due to limited clinical use

3 Comment to consider the inclusion of RIT with ibritumomab tiuxetan as a second-line therapy option. was to include RIT with ibritumomab tiuxetan as a second-line therapy option. This was added as a category 2B recommendation. Vanazzi A, Grana C, Crosta C, et al. Efficacy of (9)(0)Yttriumibritumomab tiuxetan in relapsed/refractory extranodal marginalzone lymphoma. Hematol Oncol 2014;32: Mantle Cell Lymphoma (MANT) reassess the inclusion of the CALGB regimen as an induction regimen under the The panel discussion and consensus was that the CALGB regimen should be removed as an induction regimen under the aggressive treatment options due to limited clinical use reassess the inclusion of the sequential RCHOP/RICE regimen as an induction regimen under the aggressive treatment options for The panel discussion and consensus was that the sequential RCHOP/RICE regimen should be removed as an induction regimen under the aggressive treatment options due to limited clinical use

4 consider the inclusion of bendamustine and rituximab as an induction regimen under the Based on the noted references and discussion, the panel consensus was to include bendamustine and rituximab as an induction regimen under the aggressive treatment options. This was added as a category 2B recommendation. Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet 2013;381: Flinn IW, van der Jagt R, Kahl BS, et al. Open-label, randomized, noninferiority study of bendamustine rituximab or R-CHOP/R-CVP in first-line treatment of advanced indolent NHL or MCL: the BRIGHT study. Blood 2014;123: reassess the inclusion of cladribine + rituximab as an induction regimen under the less consider the inclusion of RBAC (rituximab, bendamustine, cytarabine) as an induction regimen under the less of novel treatment options, the panel consensus was that cladribine + rituximab should be removed as an induction regimen under the less aggressive treatment options due to limited clinical use. was to include RBAC as an induction regimen under the less aggressive treatment options. This was added as a category 2B recommendation. Visco C, Finotto S, Zambello R, et al. Combination of rituximab, bendamustine, and cytarabine for patients with mantle-cell non- Hodgkin lymphoma ineligible for intensive regimens or autologous transplantation. J Clin Oncol 2013;31: Comment to reassess the inclusion of FC (fludarabine, cyclophosphamide) ± rituximab as a second-line treatment option for of novel treatment options, the panel consensus was that FC ± rituximab should be removed as a second-line treatment option due to limited clinical use

5 Comment to reassess the inclusion of cladribine + rituximab as a second-line treatment option for reassess the inclusion of PCR (pentostatin, cyclophosphamide, rituximab) as a second-line treatment option for patients with MCL. Submission request from Pharmacyclics and Janssen Biotech, Inc to consider the available data on ibrutinib in of novel treatment options, the panel consensus was that cladribine + rituximab should be removed as a second-line treatment option due to limited clinical use. of novel treatment options, the panel consensus was that PCR should be removed as a second-line treatment option due to limited clinical use. Based on the data in the references noted in the submission, the panel consensus was for ibrutinib + rituximab to remain in the footnote for HyperCVAD and not to be included in the list of treatment regimens. The footnote reads, Rituximab + ibrutinib can be used as a pretreatment to limit the number of cycles of RHyperCVAD/rituximab maintenance. See Submission for references Diffuse Large B-Cell Lymphoma (BCEL) BCEL Submission request from Merck & Co., Inc. to consider adding pembrolizumab for the treatment of patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Based on the data in the references noted in the submission, the panel consensus supported the addition of pembrolizumab for the treatment of patients with relapsed/refractory primary mediastinal large B-cell lymphoma. This is a category 2A recommendation. See Submission for references

6 Submission request from Merck & Co., Inc. to recommend the addition of pembrolizumab as a systemic treatment option for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) solid tumors that has progressed following prior treatment and who have no satisfactory alternative treatment options or with colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Based on the data in the references noted in the submission, the panel consensus did not support the addition of these specific recommendations into the Guidelines. See Submission for references