Tag Archives: Breyanzi

Analysis of Breyanzi in CLL/SLL Demonstrates Long Survival in Patients Achieving CR; Yescarta Reduces Risk of Death in 2L LBCL; Tecartus’s RW Study Shows Improved Results when Compared with ZUMA-2; ASCO 2023 Analysis 5

ASCO 2023 Analysis 5: BMS and Gilead (Kite) presented clinical outcomes from their autologous CD19 CAR-Ts in hematological malignancies. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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The EC Grants Breyanzi Marketing Authorization in 2L LBCL

On Wednesday, May 3, BMS announced (press release) that the European Commission (EC) has granted Breyanzi (CD19 CAR-T) approval for the treatment of ≥2L LBCL patients that have relapsed within 12 months or that are refractory to 1L chemoimmunotherapy. Below, Celltelligence provides insights on Breyanzi’s approval in the EU, while comparing it with its key competitor Yescarta (Gilead’s CD19 CAR-T).

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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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Thoughts on Breyanzi Positive Results in R/R FL and MCL

On Monday, May 1, BMS announced (press release) positive topline results from Breyanzi’s (CD19 CAR-T) Ph2 TRANSCEND FL trial for patients with ≥3L FL and from its pivotal Ph1 TRANSCEND NHL 001 for ≥3L MCL. Below, Celltelligence provides insights on how Breyanzi compares to its key competitor CD19 CAR-Ts, Novartis’s Kymriah and Gilead’s Yescarta for ≥3L FL, and Gilead’s Tecartus for ≥3L MCL, while discussing its potential approval timelines for both indications in the US.

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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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Abecma and Breyanzi Sales Accelerate; Initiation of CAR-T Program in Immunology; Vector Manufacturing Facility Acquisition; Leadership Transition Plan; BMS’s Q1 2023 Earnings Call Summary

On Thursday, April 27, BMS held its Q1 2023 earnings call (press release / presentation) highlighting significant revenue increase from both Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Importantly, BMS disclosed its intention to initiate a Ph1 trial evaluating CD19 NEX-T CAR-T in severe refractory systemic lupus erythematosus (SLE). Additionally, on Wednesday, April 26, BMS announced that Giovanni Caforio, CEO and Chairman of the Board will retire on November 1, 2023 (press release). Finally, on the same day, BMS reported the acquisition of Novartis’s in-house viral vector production facility at Libertyville, Illinois, US (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 assets and its intention to enter the autoimmune field.

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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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CHMP Adopts Positive Opinion for Breyanzi in 2L LBCL; When Could Abecma Receive a CHMP Positive Opinion for ≥3L MM? March CHMP Highlights

On Friday, March 31, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Breyanzi (BMS’s CD19 CAR-T) in 2L LBCL. Below, Celltelligence provides insights on the March CHMP meeting with updated EU timelines for Breyanzi’s approval and Abecma’s (BMS’s BCMA CAR-T) regulatory pathway to gain an indication in ≥3L MM.

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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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Could Breyanzi Receive a CHMP Positive Opinion This Week? Abecma Starts EMA Assessment in ≥3L MM; March’s CHMP Agenda

On Monday, March 27, the CHMP agenda for March was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed for the third time under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section in 2L DLBCL Transplant Intended (TI) patients. Additionally, Abecma (BMS’s BCMA CAR-T) was also listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for ≥3L MM patients.

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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 Absent from February’s CHMP Highlights

On Friday, February 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights implying that it has received a second RSI for its assessment in 2L LBCL. Below, Celltelligence provides updated EU approval timelines for Breyanzi.

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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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Type II Variation for Breyanzi Listed in February’s CHMP Agenda

On Monday, February 20, the CHMP agenda for February was released. For the second time, Breyanzi (BMS’s CD19 CAR-T) was listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section in 2L DLBCL Transplant Intended (TI) patients.

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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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Increased Sales for Abecma and Breyanzi; BMS to Ramp Up Manufacturing Capacity in 2023; No Clinical or Regulatory Updates; BMS Q4 2022 Earnings Call Summary

On Thursday, February 2, BMS held its Q4 and FY 2022 earnings call (press release / presentation) highlighting significant revenue increases for both Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Additionally, management commented on BMS’s strategy to ramp up cell therapy manufacturing production in 2023. Below, Celltelligence provides insights on how Breyanzi and Abecma revenues compare with key competitors Kymriah (Novartis’s CD19 CAR-T), Yescarta (Gilead / Kite’s CD19 CAR-T), and Carvykti (JNJ / Legend’s BCMA CAR-T), while discussing the impact that BMS’s manufacturing strategy could have in its cell therapy franchise’s revenue during 2023.

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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 Meets Primary Endpoint in Pivotal Trial for R/R CLL

On Thursday, January 26, BMS announced (press release) that Breyanzi (CD19 CAR-T) has met its primary endpoint (CR) in the Ph1/2 TRANSCEND CLL 004 trial for patients with ≥3L CLL / SLL. Below, Celltelligence provides insights on Breyanzi’s market opportunity for CLL, while discussing potential approval timelines in the US.

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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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