Bristol-Myers Squibb Company BMY announced that the TRANSCEND NHL 001 study on experimental candidate lisocabtagene maraleucel (liso-cel) was successful.
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following the malignant transformation of B cells.
The long-term follow-up data from the pivotal TRANSCEND NHL 001 study demonstrated that patients with relapsed/refractory large B-cell lymphomas experienced a high rate of durable responses with low incidence of severe cytokine release syndrome and neurologic events. The study met its primary and secondary endpoints.
Among the patients evaluable for efficacy (n=256), the overall response rate was 73%, with 53% of patients achieving a complete response. Responses were similar across all patient subgroups.
Moreover, responses with liso-cel were seen across patient groups, including high-risk patients such as those with refractory disease, older patients and those with high tumor burden. The data were presented during an oral session at the 2019 ASH Annual Meeting in Orlando, FL.
We note that TRANSCEND NHL 001 is an open-label, multicenter, pivotal phase I study to determine the safety, pharmacokinetics and antitumor activity of liso-cel in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B and mantle cell lymphoma.
Based on the positive results from the study, Bristol-Myers plans to submit a Biologics License Application to the FDA by the end of the year.
The candidate was added to Bristol-Myers’ portfolio with the acquisition of Celgene Corporation for $74 billion. Additionally, each shareholder will receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a one-time potential payment of $9.00 in cash upon the receipt of the FDA approval for ozanimod (by Dec 31, 2020), liso-cel (JCAR017) (by Dec 31, 2020) and bb2121 (by Mar 31, 2021), in their respective indications.
The successful development and commercialization of the candidate will strengthen and diversify Bristol-Myers’s oncology portfolio, given the fact that its lead immuno-oncology drug Opdivo is facing stiff competition from the likes of Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq.
Shares of Bristol-Myers have gained 15.4% so far this year, outperforming the industry’s growth of 7.2%.
Earlier, Bristol-Myers and partner Acceleron Pharma Inc. XLRN announced the FDA’s notification that Reblozyl (luspatercept-aamt) will not be reviewed at the Oncologic Drugs Advisory Committee (“ODAC”) meeting scheduled for Dec 18, 2019, following the late-cycle review meeting on Dec 4, 2019.
The agency has informed Bristol-Myers that the original Prescription Drug User Fee Act (PDUFA) or target action date of Apr 4, 2020, for its supplemental Biologics License Application for Reblozyl remains the same.
Bristol-Myers is seeking approval of Reblozyl, an erythroid maturation agent representing a new class of therapy, for the treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS), who have ring sideroblasts and require red blood cell (RBC) transfusions.
The FDA recently approved the drug for the treatment of anemia in adult patients with beta thalassemia, who require regular RBC transfusions.
Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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