Tag Archives: BCMA CAR-T

Thoughts on Carvykti’s Label, Price, Manufacturing, and TAT Compared to Abecma

On Monday, February 28, 2022, JNJ / Legend announced (JNJ press release / Legend press release) that the FDA approved Carvykti (cilta-cel; autologous BCMA CAR-T) for the treatment of r/r MM after ≥4 prior lines of therapy based on results from the Ph1b/2 CARTITUDE-1 trial. Below, Celltelligence provides insights on Carvykti’s reported higher manufacturing failure rate compared with Abecma, while discussing Carvykti’s potential messaging strategy.

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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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Carvykti Approved by FDA in R/R MM After Four Lines of Previous Therapy

Following JNJ’s press release, Celltelligence has updated Carvykti’s FDA approval for r/r MM patients having received at least 4 lines of prior therapy. 

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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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CARTITUDE-1 and CARTITUDE-2 Study Updates; Carvykti Improves Clinical Outcomes Compared to Real-World Clinical Practice in R/R MM; ASH 2021 Day 3 Legend Investor Event

On Monday, December 13, Legend held their investor event highlighting updated clinical results from Carvykti’s (BCMA CAR-T; cilta-cel) Ph1b/2 CARTITUDE-1 and Ph2 CARTITUDE-2 studies in r/r MM. Below, Celltelligence provides insights on Carvykti’s improved efficacy profile compared to real-world clinical practice (RWCP) in r/r MM, while discussing whether a GSI combination is necessary to improve a BCMA CAR-T’s efficacy.

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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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Will a KarMMa Data Cut Help Abecma’s Successor Products? Safety and Efficacy Updates From bb21217’s Ph1 CRB-402 Study; Carvykti’s CARTITUDE-1 Continues Demonstrating Positive Clinical Results; ASH 2021 Day 2 Part 1

On the second day of ASH 2021, 3 clinical updates were presented by BMS, 2seventy, and Legend. Below, Celltelligence provides insights and context for each presentation.

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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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Will Abecma Receive Approval in Japan by January 2022? Could JNJ / Legend’s Carvykti be Approved by September 2022?

On Monday, December 6, Japan’s Pharmaceutical Affairs and Food Sanitation Council (PAFSC) granted Abecma (BMS’s BCMA CAR-T) a positive opinion (press release, PharmaJapan, Dec 2021). Below, Celltelligence provides insights on Abecma’s potential approval and reimbursement timeline 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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JNJ / Legend Files Carvykti in Japan for R/R MM

On Monday, December 6, Legend announced (press release) that they have submitted Carvykti’s NDA (cilta-cel; BCMA CAR-T) to Japan’s Ministry of Health Labour and Welfare (MHLW) for the treatment of r/r MM. Below, Celltelligence provides insights on a likely approval timeline for Carvkyti 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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Novartis’s T-Charge Platform Reduces CAR-T Manufacturing to 2 Days; Novartis’s R&D Day Summary

On Thursday, December 2, Novartis held their R&D day (press release / presentation) highlighting T-Charge, a next-generation CAR-T manufacturing platform that reduces manufacturing time to ~2 days. Moreover, management discussed two novel assets YTB323 (CD19 CAR-T) and PHE885 (BCMA CAR-T) manufactured using the T-Charge platform. Below, Celltelligence provides insights on how Novartis could leverage T-Charge’s rapid manufacturing and potentially lower COGS to position their novel assets within the already crowded DLBCL and MM settings.

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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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The EC Grants Abecma (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, August 19, BMS announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Abecma (BCMA CAR-T) in ≥4L r/r MM. Below, Celltelligence provides insights on Abecma’s conditional approval in the EU while discussing how BMS’s manufacturing strategy could impact Abecma’s TATs in Europe.

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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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JNJ / Legend Announce a New EU Manufacturing Site in Belgium

On Tuesday, June 22, JNJ (press release) and Legend (press release / presentation) announced the establishment of a state-of-the-art manufacturing facility in Ghent, Belgium. Of note, the new manufacturing site could become a key pillar for JNJ / Legend’s global collaboration to develop and commercialize cilta-cel (BCMA CAR-T). Below, Celltelligence provides insights into JNJ / Legend’s potential manufacturing strategy in Europe and how this compares to key competitor BMS.

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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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JNJ / Legend Receive Priority Review for Cilta-cel in MM; Approval Before Thanksgiving?

On Wednesday, May 26, Legend announced (press release) that the FDA has granted cilta-cel (BCMA CAR-T) Priority Review in r/r MM, with a projected PDUFA date around November 29, 2021. Furthermore, management confirmed that updated results from the Ph1b/2 CARTITUDE-1 trial will be presented at ASCO 2021. Below, Celltelligence provides additional thoughts on cilta-cel’s anticipated US approval and its potential best-in-class efficacy profile, while discussing JNJ’s / Legend’s possible US ATC onboarding 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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