Tag Archives: Legend

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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Carvykti’s Type II Variation Application Submitted to the EMA; Carvykti’s Submission to the FDA Planned; Could Carvykti be First Approved for ≥2L MM in Europe Ahead of the US?

On Thursday, May 25, Legend announced (press release) that a Type II Variation (T2V) application was submitted to the EMA for Carvykti’s (BCMA CAR-T) use in ≥2L MM patients. Below, Celltelligence provides insights on Carvykti’s regulatory timelines to gain a label extension for this setting in Europe, while discussing its to-date absent filing with the FDA.

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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 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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UPDATED: Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Requirements; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

UPDATED: On April 3, 2023, Celltelligence published a blast entitled “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”. Since then, Janssen reached out to Celltelligence to clarify that FDA’s safety “concern” is really more about meeting a “requirement” for re-filing the IND than anything else. The team has updated the April 3 blast to reflect the clarity provided by Janssen.

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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 +31% QoQ; Novartis to Manufacture Carvykti; JNJ Q1 2023 Earnings Call Summary

(Celltelligence is aware of the CARTITUDE-4 abstract leak and will have a thoughts-on analysis after the team returns from AACR.)

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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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Adaptimmune and GSK Agree to Terms for PRAME and NY-ESO Programs Transfer; Kristin Yarema to Serve as Poseida’s President for Cell Therapy; Mythili Koneru Appointed as Legend’s CMO

On Tuesday, April 11, Adaptimmune announced (press release) the terms of the agreement with GSK for transferring back PRAME and NY-ESO programs. On the same day, Poseida and Legend reported the appointments of Kristin Yarema as Poseida’s Cell Therapy President (press release) and Mythili Koneru as Legend’s CMO (press release). Below, Celltelligence provides insights on the transition of GSK’s PRAME and NY-ESO programs back to Adaptimmune, while discussing the potential benefits of the new appointments for Poseida and Legend.

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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’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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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 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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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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