The DLBCL late-stage pipeline shrinks dramatically as three Phase III trials fall short.
By Rachael Lloyd, Analyst
4 August 2016
I am a disease analyst at Datamonitor Healthcare, specialising in oncology. I joined the team in September 2015 having p...
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The diffuse large B-cell lymphoma (DLBCL) late-stage pipeline has become significantly smaller after three Phase III clinical trials failed to produce efficacious results across a range of treatment settings. Roche’s Gazyva (obinutuzumab) failed to outperform Rituxan (rituximab) in the first-line setting and there still remains an unmet need for maintenance therapies now that Afinitor (everolimus; Novartis) and Revlimid (lenalidomide; Celgene) failed to show adequate survival benefits in this setting.
In July 2016, Roche announced that the pivotal Phase III GOYA trial (ClinicalTrials.gov identifier: NCT01287741) had failed to meet its primary endpoint, and Gazyva had not significantly improved progression-free survival when used in place of Rituxan alongside CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy in previously untreated CD20-positive DLBCL patients.
In June 2016, Novartis announced that Afinitor had failed to meet its primary endpoint in the Phase III PILLAR-2 trial (ClinicalTrials.gov identifier: NCT00790036) comparing Afinitor to placebo as a maintenance therapy for the treatment of Stage III/IV DLBCL patients in complete remission after Rituxan-based induction chemotherapy. Treatment with Afinitor failed to demonstrate a statistically significant increase in disease-free survival compared to placebo (78% versus 77%).
In July 2016, Celgene announced that it had suspended development of Revlimid as a single agent maintenance therapy for the treatment of patients responding to Rituxan-based induction chemotherapy. This decision was based on the results of the Phase III REMARC trial (ClinicalTrials.gov identifier: NCT01122472), which failed to reach its secondary endpoint and increase overall survival in comparison to placebo.
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