Tag Archives: BMS

Promising Efficacy Data from BMS’s GPRC5D CAR-T in ≥4L MM; Abecma Demonstrates Superiority Vs SOC in ≥3L MM Across All High-Risk Subgroups; Preliminary Clinical Data from Innovent’s P329G-CAR-T in ≥4L MM; EHA 2023 Analysis 2

EHA 2023 Analysis 2: BMS / 2seventy bio and Innovent / Roche presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations, where the first topic also includes an evidence roundup of the PDUFA date for Janssen’s talquetamab. The following topics are covered:

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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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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 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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No Cell Therapy-Related Updates in May’s CHMP Agenda; Abecma Likely to Be Included in June’s Agenda

On Monday, May 22, the CHMP Agenda for May was released. Of note, Abecma’s (BMS’s BCMA CAR-T) Type II Variation (T2V) for ≥3L MM was absent from the agenda, and no other cell therapy-related updates were observed. Therefore, based on the agenda, no updates are expected on the CHMP highlights to be published on Friday, May 26.

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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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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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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 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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No Cell Therapy-Related Updates in April’s CHMP Agenda

On Monday, April 24, the CHMP Agenda for April was released. Of note, no cell therapy-related updates were observed. Recall that Abecma’s (BMS’s BCMA CAR-T) indication extension to ≥3L MM patients could potentially be included in May’s CHMP agenda (see previous insight).

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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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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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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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Topline Results from Abecma’s KarMMa-3 in ≥3L MM; BMS, Gilead (Kite), and Novartis Present Clinical Updates from Leading CAR-T Assets; EBMT – EHA CAR-T Meeting 2023 Analysis 2

EBMT – EHA CAR-T Meeting 2023 Analysis 2: BMS, Kite (Gilead), and Novartis presented clinical data and follow-up outcomes from their leading CAR-T therapies. 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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