Tag Archives: Liso-cel

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 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 December’s CHMP Agenda

On Monday, December 12, the CHMP agenda for December was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, December 16, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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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 November’s CHMP Agenda

On Monday, November 7, the CHMP agenda for November was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, November 11, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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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 Included in the NCCN Guidelines for the Treatment of 2L DLBCL

On Tuesday, July 12, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas were updated (NCCN Guidelines in B-Cell Lymphoma) to include Breyanzi’s (BMS’s CD19 CAR-T) treatment in 2L DLBCL. Of note, Breyanzi is now recommended as a 2L therapy for patients who have primary refractory disease or have relapsed within 12 months, as well as patients who are non-candidates for transplant. Below, Celltelligence provides insights on Breyanzi’s inclusion in the NCCN Guidelines, while discussing how Yescarta’s (Gilead / Kite’s CD19 CAR-T) NCCN recommendation.

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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’s FDA Approval in 2L LBCL

On Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL. Of note, Breyanzi’s approval in 2L LBCL is based on results from the Ph3 TRANSFORM study and Ph2 PILOT trial. Below, Celltelligence provides insights on how Breyanzi’s broad label in 2L LBCL compares with key competitor Yescarta (Gilead / Kite’s CD19 CAR-T), while discussing how BMS may position Breyanzi in the 2L setting.

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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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Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

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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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Ide-cel Reverts to Standard Assessment; Liso-cel’s Potential Scenarios for Approval; CHMP February Agenda and Highlights

On Friday, February 26, CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, regulatory updates for BMS’s liso-cel (CD19) and ide-cel (BCMA) CAR-T products were observed, including ide-cel’s start of standard review following its loss of accelerated assessment (AA) in December 2020. No updates for cilta-cel were provided. Below, Celltelligence provides insights on possible EC approval dates for liso-cel and ide-cel.

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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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BMS’s New US Cell Therapy Manufacturing Site; bluebird bio Quiet on Earnings; Former Kite Head of Development Joins Daiichi Sankyo

On Tuesday, February 23, BMS announced (press release) the construction of a new cell therapy manufacturing facility in Devens, Massachusetts. On the same day, bluebird bio released their Q4 and FY 2020 results (press release) without an investor call. Finally, Daiichi Sankyo announced (press release) Ken Takeshita, former Kite global head of development, will join the company as global head of R&D. Below, Celltelligence provides insights on BMS’s possible manufacturing footprint strategy, as well as thoughts on how Takeshita’s cell therapy experience could influence Daiichi Sankyo’s R&D strategy.

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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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Thoughts on Breyanzi’s (liso-cel) Label, Price, Manufacturing, and TAT Compared to Kymriah and Yescarta

On Friday, February 5, BMS announced (press release) that the FDA approved Breyanzi (lisocabtagene maraleucel) for the treatment of r/r LBCL after ≥2L systemic therapy, which is essentially ≥3L r/r DLBCL. The application was based on data from the Ph1 TRANSCEND NHL 001 trial. Below, Celltelligence provides insights on Breyanzi’s approval, the higher DLBCL list price vs. Kymriah and Yescarta, how BMS may position Breyanzi in the CD19 CAR-T setting, why supplying Breyanzi in vials is strategically important, and a look at the Breyanzi mobile app.

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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No Regulatory Updates for Liso-cel; Orva-cel Discontinued; BMS Q4 2020 Earnings Call Summary

On Thursday, February 4, BMS held their Q4 2020 results (press release / presentation). Management discussed liso-cel’s possible imminent approval and their strategy for rapid ATC onboarding. Of note, BMS’s humanized BCMA CAR-T orva-cel has been discontinued. Below, Celltelligence provides insights on BMS’s potential strategy for liso-cel and thoughts on orva-cel’s discontinuation.

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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