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How Celgene’s Gene Therapy Business Is Positioned

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JCAR017’s growth prospects

On March 6, Celgene (CELG) announced the completion of its acquisition of Juno Therapeutics, adding Juno’s CD-19 targeted CAR-T[1.chimeric antigen receptor T-cell] therapy, JCAR017 (lisocabtagene maraleucel), to Celgene’s portfolio. With its peak sales projected to be ~$3.0 billion, JCAR017 is expected to be a foundational therapy for non-Hodgkin lymphoma (or NHL). In December 2016, the FDA designated JCAR017 as a breakthrough therapy for NHL.

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Celgene has completed patient enrolment in TRANSCEND, a Phase 1/2 trial evaluating JCAR017 for treating diffuse large B-cell lymphoma. JCAR017’s Phase 2 TRANSCEND WORLD trial is also on track this year. The company expects to secure FDA approval for JCAR017 as a treatment for diffuse large B-cell lymphoma (or DLBCL) in 2019, and is preparing to commence its PILOT and TRANSFORM studies to evaluate JCAR017 as a second-line treatment for transplant non-eligible DLBCL and transplant-eligible DLBCL, respectively.

Celgene is also recruiting patients for its TRANSCEND-CLL trial, which will evaluate JCAR017 as a third-line treatment for chronic lymphocytic leukemia. This trial’s data is expected later this year. The diagram below shows how JCAR017 fits into Celgene’s overall NHL strategy.

bb2121’s growth trends

On June 1, Celgene announced positive results for CRB-401, a Phase 1 trial evaluating BCMA (B-cell maturation antigen) CAR-T therapy bb2121 for relapsed or refractory multiple myeloma (or R/R MM). The trial data has demonstrated a strong safety profile.

Celgene is enroling patients in KarMMa, a pivotal Phase 2 study evaluating bb2121 for R/R MM. The company also plans to commence a Phase 3 study evaluating bb2121 as a third-line treatment for multiple myeloma by the end of this year, and expects to secure FDA approval for bb2121 for R/R MM by 2020.

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