Tag Archives: CARTITUDE-4

Carvykti’s sBLA Application Submitted to the FDA after Outperforming the SOC on CARTITUDE-4 Trial in ≥2L MM; Longer-term Follow-up Data for CARTITUDE-1 and LEGEND-2 Trials; ASCO 2023 Analysis 4

ASCO 2023 Analysis 4: JNJ and Legend presented results for Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2-4L MM, which are the base of its sBLA submission to the FDA, announced by Legend on June 6, 2023 (press release). Additionally, 3-year and 5-year follow-up analyses for Carvykti’s Ph1b/2 CARTITUDE-1 and LEGEND-2 trials in ≥4L MM, respectively, were presented during ASCO 2023. Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC and the timeline of its potential FDA approval while discussing its curative potential for a wide range of MM patients.

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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 to Present Multiple Updates at ASCO and EHA 2023; Legend to Use Raised Funding for Carvykti’s Development; Legend’s Q1 2023 Earnings Summary

On Thursday, May 18, Legend reported its Q1 2023 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) upcoming clinical presentations at ASCO and EHA 2023, and its WW revenue during this period. Below, Celltelligence provides insights on CARTITUDE-4 data to be presented in the upcoming conferences and Carvykti’s future development.

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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 CARTITUDE-4’s EHA Abstract Being Prematurely Posted; Carvykti Demonstrates an Impressive Efficacy Profile in 2-4L MM

On Tuesday, April 18, Carvykti’s (JNJ / Legend’s BCMA CAR-T) topline results of its Ph3 CARTITUDE-4 trial were reported after its abstract was unintentionally posted on EHA’s website. The results suggest a superior efficacy profile of Carvykti over SOC therapy (news, Endpoints News, Apr 2023). Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC while discussing its potential to become the new SOC therapy in the 2L MM 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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Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Concerns; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

On Thursday, March 30, Legend reported its H2 and FY 2022 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) positive topline results from the Ph3 CARTITUDE-4 trial in 2-4L MM, as well as intentions to first proceed with the Ph3 CARTITUDE-6 trial for NDMM in ex-US countries after FDA safety concerns. Below, Celltelligence provides insights on Carvykti’s anticipated evaluation in NDMM as well as its potential FDA approval in 2-4L MM, while discussing Legend’s presence in the SCLC space.

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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 Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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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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Carvykti’s CARTITUDE-4 Met its Primary Endpoint in r/r MM

On Friday, January 27, Legend Biotech announced (press release) that Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM met its primary endpoint (PFS), demonstrating a statistically significant improvement compared to the SOC (PVd or DPd). The Celltelligence team will be conducting an in-depth analysis in the coming days.

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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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JPM 2023 Analysis Day 1: BMS, Novartis, JNJ, and Gilead

On the first day of JPM 2023, Celltelligence covered presentations by BMS (presentation), Novartis (presentation), JNJ (webcast), and Gilead (presentation). Below, Celltelligence provides insights and context for each presentation. 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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Carvykti’s Revenue Increases to $55M; JNJ Expects Franchise to Generate $5B by 2025; Will Carvykti be Approved in 2L MM by Q3 2023? JNJ Q3 2022 Earnings Call Summary

On Tuesday, October 18, JNJ held their Q3 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) potential to generate $5B by 2025. Additionally, management confirmed that a data readout from Carvykti’s Ph3 CARTITUDE-4 trial in 2-4L MM is expected by YE 2022. On the same day, Legend disclosed (SEC filing, Oct 2022) that Carvykti’s preliminary WW sales for Q3 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s revenue increase, while discussing potential US regulatory timelines for Carvykti in 2L MM.

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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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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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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.

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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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