Celgene Presents Data On CAR T Therapy, Revlimid & Pomalyst

Celgene Corporation (NASDAQ:CELG) presented data on its oncology drugs Revlimid, Pomalyst along with other experimental therapies in the presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Celgene announced encouraging updated six-month safety and efficacy data from the open-label, multicenter phase I study, TRANSCEND (NHL-001), on experimental CD19-directed CAR T cell therapy candidate, lisocabtagene maraleucel (liso-cel; JCAR017), in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) at the ASCO.

TRANSCEND is being conducted to determine the safety, pharmacokinetics and antitumor activity of liso-cel in adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.

Based on a cutoff date of May 4, 2018, 49% of patients remained in remission with 46% maintaining a complete response (CR) in this cohort (n=37). Durability of response beyond six months was evaluated across all dosing levels ranging from 5 x 107 to 1 x 108 CAR T cells, wherein 93% of patients in CR remained in CR at data cut-off. The data demonstrate the potential of the candidate in patients with DLBCL, who have relapsed or are refractory to prior treatments.

Concurrently, Celgene also announced additional results from the phase III randomized, open-label, international study, RELEVANCE at the ASCO. The study was conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC).

The study evaluated Revlimid plus Roche’s (OTC:RHHBY) Rituxan (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. Results 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 had earlier reported that the study did not achieve the primary endpoints of superior PFS and CR/CRu. The company now awaits results from the AUGMENT study, which is evaluating this important regimen in previously treated patients with indolent lymphomas.

Earlier, Celgene and partner bluebird bio, Inc. (NASDAQ:BLUE) announced encouraging updated results from the ongoing open-label phase I study, CRB-401 on bb2121, an experimental anti-B-cell maturation antigen (BCMA) CAR T cell therapy in 43 patients with late-stage relapsed/refractory multiple myeloma. The study is evaluating the preliminary safety and efficacy of bb2121 anti-BCMA CAR T cell therapy in patients with relapsed/refractory multiple myeloma.

Patients in the study were heavily pre-treated with a median of seven prior myeloma treatment regimens (min, max: 3,14) in the dose escalation cohort (n=21) and eight prior regimens (min, max: 3, 23) in the dose expansion cohort (n=22). The study results show that responses were dose-related and observed for both low and high BCMA expression levels. The median progression-free survival (PFS) estimate for patients in the dose-escalation phase, treated at active doses, was 11.8 months, while patients receiving 50 x 106 CAR+ T cells had a median PFS of 2.7 months.

We remind investors that bb2121 has been granted Breakthrough Therapy Designation in the United States and PRIME eligibility from the EMA. In addition, Celgene has also sponsored an open-label, single-arm, pivotal, phase II study (KarMMa), which is currently recruiting in North America and Europe, to evaluate bb2121 further in patients with relapsed and refractory multiple myeloma (NCT03361748).

Moreover, Celgene also presented positive data for a phase III randomized, open-label study, OPTIMISMM, on the experimental combination regimen of Pomalyst, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM), who had received at least one prior treatment including lenalidomide at the ASCO.

The trial evaluated the efficacy and safety of Pomalyst/Imnovid (pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone (Vd) in patients with early RRMM. The study data showed that the treatment with PVd resulted in significantly improved PFS and an earlier, deeper and more durable response in these patients compared to Vd treatment. The study met its primary endpoint.

Pomalyst in combination with dexamethasone is indicated for patients with multiple myeloma, who have received at least two prior therapies.

Celgene is desperately looking to revamp its portfolio, due to series of setbacks over the last few months.

Celgene’s stock has lost 23% in the last six months compared with the industry’s decline of 6.4%. Celgene suffered a setback when it received a Refusal to File letter from the FDA, regarding the New Drug Application (NDA) for ozanimod in relapsing multiple sclerosis (RMS). Moreover, the threat of generic competition is also looming large on Revlimid, which loses patent protection in 2022 forcing Celgene to look for acquisitions.

Celgene was on the look-out of new deals and acquisitions, given a lacklustre 2017 and the Juno acquisition was on the same track. Celgene announced a global collaboration with Prothena (NASDAQ:PRTA) in March 2018 to develop new therapies for a broad range of neurodegenerative diseases primarily focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, TDP-43 and an undisclosed target.

Zacks Rank

Celgene is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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