Celgene Corporation’s study testing Revlimid on patients with previously untreated follicular lymphoma showed that treatment with a chemotherapy-free R2 regimen offered numerically similar efficacy results for the primary endpoints of progression free survival (PFS) and complete response or unconfirmed complete response (CR/CRu) at 120 weeks with a different safety profile than treatment with the conventional R-chemo standard.
Celgene pointed out in its press release a previous disclosure that the study, done in partnership with the Lymphoma Academic Research Organisation (LYSARC), did not achieve the primary endpoints of superior PFS and CR/CRu.
The study tested Revlimid plus rituximab (R2), followed by R2 maintenance, an investigational regimen, compared to the standard of care treatment of rituximab plus chemotherapy followed by rituximab maintenance in patients with previously untreated follicular lymphoma.
“These findings provide important insight into the efficacy and safety of a chemotherapy-free regimen in patients with previously untreated follicular lymphoma and represent an important step forward in understanding possible treatment options for these patients,” said Nathan Fowler, from the University of Texas MD Anderson Cancer Center.
Nadim Ahmed, President of Hematology and Oncology for Celgene believes the findings of the Relevance trial add further to the understanding of the R2 regimen in patients with follicular lymphoma. “We now look forward to the results of our Augument study, which is evaluating this important regimen in previously treated patients with indolent lymphomas. These studies support our ongoing efforts to develop a portfolio of novel treatments for lymphoma,” Ahmed has said.
Revlimid alone or in combination with rituximab is not approved for use in follicular lymphoma in any country, Celgene noted.
Updated results with liso-cel underscore potential for best-in-class CAR T profile for patients with poor prognosis for Relapsed or Refractory B-cell non-Hodgkin Lymphoma
In another press release, Celgene announced updated six-month safety and efficacy data from the Transcend study of lisocabtagene maraleucel (liso-cel), an investigational CD19-directed CAR T cell therapy, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL).
The principal investigator Jeremy Abramson said: “As liso-cel data mature, the durable response rates continue to demonstrate the potential of CAR T cell therapy in patients with DLBCL who have relapsed or are refractory to prior treatments. Added to the emerging side effect profile with liso-cel, this therapy has encouraging potential in diffuse large B-cell lymphoma.”
The update provided today was based on a cutoff date of May 4, 2018 and included data from 114 liso-cel treated and 102 safety evaluable patients, of which 51 patients were treated at the pivotal dose of 100 million cells. Abramson highlighted 37 patients who meet the criteria for the planned pivotal patient population in the study, and were treated with the pivotal cell dose.
“The updated efficacy and tolerability data for liso-cel continue to support a potential best-in-class CD19 CAR T profile,” said Nadim Ahmed. “With the TRANSCEND pivotal cohort now fully enrolled, we look forward to further progressing this critical program for poor-prognosis patients with relapsed or refractory aggressive NHL and investigating the clinical utility of liso-cel in earlier lines of therapy.”