Tag Archives: Breyanzi

You May Have Missed: New Breyanzi Ph3 Trial for R/R FL; Abecma Approved for 3L MM in the EU

In the past week, the Celltelligence team detected relevant news that was not discussed in individual blasts but worth highlighting. In this blast, Celltelligence will cover the following topics:

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi Receives FDA Accelerated Approval in ≥3L CLL/SLL

On Thursday, March 14, BMS announced (press release) that the FDA granted accelerated approval (AA) of Breyanzi (CD19 CAR-T) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) adult patients who have received at least 2 prior LoT including a BTK inhibitor and a BCL-2 inhibitor.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Abecma and Breyanzi Revenues Increase; BMS-986353 to be Evaluated in MS; BMS’s Q4 2023 Earnings Call Summary

On Friday, February 2, BMS held its Q4 2023 earnings call (press release / presentation) highlighting the increase in global sales of Abecma (BMS / 2seventy bio’s BCMA CAR-T) and Breyanzi (CD19 CAR-T) while reporting plans to evaluate its BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in multiple sclerosis (MS).

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi Regulatory Applications for R/R FL and R/R MCL Accepted in the US and Japan

On Tuesday, January 30, BMS announced (press release) that the Breyanzi (CD19 CAR-T) sBLAs for r/r FL and r/r MCL have been accepted by the FDA with projected PDUFA dates on May 23, 2024, and May 31, 2024, respectively. Additionally, the application for Breyanzi in r/r FL has also been validated in Japan.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi Demonstrates Excellent Efficacy in 2L HR FL; Galapagos’s Point-of-Care Manufactured GLPG5101 Shows a Promising Efficacy and Safety Profile; ASH 2023 Analysis 4

ASH 2023 Analysis 4: BMS and Galapagos presented updated clinical data about their cell therapies in lymphoma. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi Demonstrates Long Duration of Response in 2L Transplant Ineligible LBCL and Consistent RW Results Regardless of Comorbidities in R/R LBCL; Prior Bridging Therapy Does Not Impact Yescarta Efficacy or Safety in R/R LBCL; ASH 2023 Analysis 3

ASH 2023 Analysis 3: Gilead (Kite) and BMS presented real-world (RW) and clinical data updates in r/r LBCL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi sBLA for R/R CLL/SLL Receives FDA Priority Review

On Thursday, November 9, BMS announced (press release) FDA accepted the sBLA for the expansion of Breyanzi’s (CD19 CAR-T) label to include r/r chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The company confirmed that the FDA has granted Priority Review to the application and set a PDUFA date of March 14, 2024. Below, Celltelligence provides insights on the results of the Ph1/2 TRANSCEND CLL 004 trial supporting the application while discussing BMS’s strategy for the hypothetical use of Breyanzi in 2L CLL/SLL.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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BMS’s Cell Therapy Franchise Sales Decrease; KarMMa-9 Initiated; The FDA Clears BMS-986353’s IND in MS; First Patients in SLE Trial Dosed; BMS’s Q3 2023 Earnings Call Summary

On Thursday, October 26, BMS held its Q3 2023 earnings call (press release / presentation) disclosing a significant revenue decrease for Abecma (BCMA CAR-T) and a decline in Breyanzi (CD19 CAR-T) sales. Additionally, BMS confirmed the dosing of the first patient in the Ph1 trial evaluating BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in severe refractory systemic lupus erythematosus (SLE), while announcing IND clearance from the FDA to start a trial in multiple sclerosis (MS). Below, Celltelligence provides insights on the potential causes behind the Abecma and Breyanzi sales drops while discussing the initiation of the Ph3 KarMMa-9 trial in NDMM and BMS’s fast progress in the autoimmune disease space.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Abecma Sales Decrease While Breyanzi Revenue Keeps Growing; Plans to Start a BMS-986393 Registrational Trial; BMS Invests in Immatics; BMS’s Q2 2023 Earnings Call Summary

On Thursday, July 27, BMS held its Q2 2023 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales increase while reporting a revenue decrease for Abecma (BCMA CAR-T). Furthermore, the company underscored clinical and regulatory milestones of its cell therapy assets, disclosing a new potentially registrational trial for BMS-986393 (CC-95266; GPRC5D CAR-T). Finally, on Monday, July 24, Immatics announced a $35M equity investment from BMS (press release). Below, Celltelligence provides insights on how Abecma and Breyanzi sales compare to key competitors while discussing the main clinical milestones achieved by BMS’s marketed cell therapy assets in Q2 2023 and the company’s regulatory plans for its CAR-T programs.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Impressive Results for Breyanzi in ≥3L FL and ≥3L MCL; MB-106 Demonstrates Excellent Efficacy and Safety in R/R FL

On Saturday, June 17, BMS presented results from Breyanzi’s (CD19 CAR-T) Ph2 TRANSCEND FL trial in r/r FL patients and a primary analysis from the MCL cohort of the Ph1 TRANSCEND NHL 001 trial at ICML 2023. Moreover, Mustang Bio presented data from the FL cohort dosed with MB-106 (CD20 CAR-T) in the single-center Ph1/2 trial that led to the initiation of a registrational Ph1/2 trial for the treatment of r/r B-NHL or CLL in the same conference. Below, Celltelligence provides insights on how Breyanzi’s results compare to its key competitor CD19 CAR-Ts in ≥3L FL and ≥3L MCL, and discusses potential approval timelines for both indications in the US while analyzing which assets could rival MB-106 to become the first approved CD20 CAR-T.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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