Category Archives: Autologous

CARTITUDE-1 and CARTITUDE-2 Study Updates; Carvykti Demonstrates Durable Responses at 2-Year Follow-Up; Legend Reports Delayed Cases of Parkinsonism; ASCO 2022 Legend Investor Event

On Sunday, June 5, Legend held their ASCO 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 durable responses in comparison with Abecma (BMS’s BCMA CAR-T), while discussing whether parkinsonism could require a novel mitigation 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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Gilead (Kite) and 2seventy Bio Present Study Designs for their Next-Generation Assets Targeting Hematologic Malignancies; ASCO 2022 Analysis 3

ASCO 2022 Analysis 3: Gilead (Kite) and 2seventy bio reported study designs for their novel assets treating B cell malignancies. 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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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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Initial Data from Yescarta’s Ph2 ZUMA-14 Study for R/R LBCL in Combination with Rituximab; Updated Results for Tecartus in ALL and MCL; ASCO 2022 Analysis 2

ASCO 2022 Analysis 2: Gilead (Kite) reported updated clinical data in LBCL, MCL, and adult B-ALL. 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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The Race Continues in the 2L LBCL Setting; BMS and Gilead Provide Clinical Updates for Breyanzi and Yescarta; ASCO 2022 Analysis 1

ASCO 2022 Analysis 1: Gilead (Kite) and BMS presented clinical data updates in 2L LBCL. 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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Thoughts on Carvykti’s EC Conditional Marketing Authorization in ≥4L r/r MM

On Thursday, May 26, JNJ announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Carvykti (cilta-cel; BCMA CAR-T) in ≥4L r/r MM. Below, Celltelligence provides thoughts on Carvykti’s EC approval and its potential launch strategy within 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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Carvykti Meets Another Regulatory Milestone; LB1901’s FDA Clinical Hold Lifted; Legend Q1 2022 Earnings Summary

On Wednesday, June 1, Legend released their Q1 2022 results (press release) highlighting Carvykti’s (cilta-cel; BCMA CAR-T) recent European Commission (EC) conditional marketing authorization in ≥4L r/r MM. Additionally, management confirmed that the FDA lifted the clinical hold on LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on Carvykti’s EC approval, while discussing LB1901’s FDA clinical hold lift.

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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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Kymriah Receives FDA Approval for R/R FL After Two or More Lines of Systemic Therapy

Late on Friday, May 27, Novartis announced (press release) that the FDA granted accelerated approval for Kymriah (CD19 CAR-T) in ≥3L r/r FL. Kymriah is the second CAR-T to be approved by the FDA in r/r FL. Of note, Kymriah’s FDA approval was based on results from the Ph2 ELARA trial, with 86% and 68% of patients achieving an ORR and CR, respectively. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days (link to PI).

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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 Carvykti (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, May 26, JNJ announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Carvykti (cilta-cel; BCMA CAR-T) in ≥4L r/r MM. Of note, Carvykti’s EC approval was based on results from the Ph1b/2 CARTITUDE-1 trial. The Celltelligence team will be conducting a full thoughts-on analysis in the coming days.

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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Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from May’s CHMP Highlights

On Friday, May 20, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL and Tecartus (Gilead / Kite’s CD19 CAR-T) for r/r ALL were absent from May’s CHMP highlights. Below, the Celltelligence team provides updated EU timelines for Yescarta in 2L LBCL and Tecartus in r/r ALL.

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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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Gracell Q1 2022 Earnings Call

On Monday, May 16, Gracell held their Q1 2022 earnings call (press release / presentation).

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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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