Tag Archives: CARTITUDE-5

CARTITUDE-6 to Start Recruiting Soon in the US; Legend’s Facility in Belgium Set to Start Clinical Trial Manufacturing; Legend’s Q3 2023 Earnings Call Summary

On Monday, November 20, Legend held its Q3 2023 earnings call (press release) highlighting that the Ph3 CARTITUDE-6 trial evaluating Carvykti (BCMA CAR-T) versus ASCT in NDMM will start recruitment soon in the US while noting that its new production plant in Ghent, Belgium will be ready for clinical trial manufacturing by YE 2023. Below, Celltelligence provides insights on JNJ / Legend strategies to increase Carvykti manufacturing capacity, while discussing a slowdown of Carvykti’s sales in Q4 2023 and the initiation of CARTITUDE-6 trial in the US.

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Carvykti’s sBLA in 2L MM Did Not Receive Priority Review; JNJ / Legend Continue To Improve Manufacturing Capacity; Updates on Solid Tumor Programs; Legend’s Q2 2023 Earnings Call Summary

On Tuesday, August 15, Legend held its Q2 2023 earnings call (press release) highlighting that the FDA set a PDUFA date for Carvykti’s (BCMA CAR-T) sBLA in ≥2L MM on April 5, 2024. Moreover, management listed measures that the company is taking to improve its manufacturing capacity and reported updates on its solid tumor programs. Below, Celltelligence provides insights on the FDA’s standard review of Carvykti’s sBLA while discussing future development for Carvykti and the company’s solid tumor programs.

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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 Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

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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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Legend Continues to Expand the CARTITUDE Program; Will Carvykti Receive Approval in Japan by September 2022? Legend Receives Official FDA Clinical Hold Letter for LB1901; Legend Q4 2021 Earnings Summary

On Friday, March 18, Legend released their Q4 2021 results (press release) highlighting Carvykti’s (cilta-cel; BCMA CAR-T) recent FDA approval in ≥5L r/r MM and several clinical program updates. Additionally, management confirmed that they received an official FDA clinical hold letter for LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on Legend’s LCM initiatives for Carvykti, while discussing LB1901’s FDA clinical hold.

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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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Cilta-cel to be Commercialized as Carvykti Upon FDA Approval; JNJ Highlights Innovative Manufacturing and Supply System for Carvykti; How Quickly Could Carvykti Move Into Earlier Lines? JNJ’s Business Review Event 2021

On Thursday, November 18, JNJ held their Pharmaceutical Business Review 2021 Event (website) revealing cilta-cel’s (BCMA CAR-T) brand name as Carvykti, while commenting on their manufacturing and supply strategy to ensure a strong launch for Carvykti. Additionally, management emphasized their plan to quickly advance Carvykti into earlier lines of treatment. Below, Celltelligence provides insights on how JNJ’s manufacturing strategy may ensure a successful launch for Carvykti, while comparing JNJ’s digital platform with key competitors Gilead (Kite) and BMS. Moreover, Celltelligence will comment on the potential challenges JNJ may encounter advancing Carvykti into earlier lines for MM.

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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