Tag Archives: Tecartus

GSK Explores Better Patient Selection Methods for Lete-cel; Could 2seventy bio Nominate Medigene’s PRAME TCR-T as Their Second Target? Adaptimmune Presents Preclinical Data from ADP-A2M4CD8; No Updated Preclinical Results from Carisma; Tecartus Absent from CHMP Highlights; ESMO 2021 Day 1&2

On the first two days of ESMO 2021, four key pre-clinical and clinical presentations from GSK, Medigene, Adaptimmune, and Carisma were presented. On Friday, September 17, the CHMP highlights for September were released. Of note, no updates from Tecartus’s Type II variation for r/r adult ALL were observed. Below, Celltelligence provides insights and context for each presentation, while providing likely EU approval timelines for Tecartus.

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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 Tecartus Receive a Positive CHMP Opinion for R/R Adult ALL This Week? Cilta-cel Remains on Track for a November 2021 Opinion; No Mention of Breyanzi or Yescarta in September’s CHMP Agenda

On Monday, September 13, the CHMP agenda for September was released. Of note, Tecartus’s (Gilead’s CD19 CAR-T) Type II Variation for r/r adult ALL is listed as ‘For Adoption’, while cilta-cel (JNJ / Legend’s BCMA CAR-T) appears under the ‘List of Questions (LoQ)’ section. No updates were observed for Breyanzi (BMS’s CD19 CAR-T) in DLBCL or Yescarta (Gilead’s CD19 CAR-T) in FL. Below, Celltelligence provides likely EU approval timelines for Tecartus and cilta-cel.

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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 Consolidates Their Position as Market Leader; Could Tecartus in R/R Adult ALL Receive A Positive CHMP Opinion By YE 2021? Gilead’s Q2 2021 Earnings Call Summary

On Thursday, July 29, Gilead held their Q2 2021 earnings call (press release / presentation) highlighting an increase in overall revenue for their cell therapy franchise, while discussing the benefits of a potential FDA approval for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Furthermore, management highlighted the submission of a Type II variation to the EMA for Tecartus (CD19 CAR-T) in r/r adult ALL. Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s and Tecartus’s expansion into new indications to consolidate their position as a cell therapy market leader, while discussing likely EU approval timelines for Tecartus.

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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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Yescarta Outperforms SoC in a Matched Analysis of ZUMA-5 in r/r FL; Tecartus’s Improved Safety Profile in the Ph1/2 ZUMA-4 Trial; Breyanzi’s Ph2 OUTREACH Trial Demonstrates the Feasibility of Outpatient Administration; Obe-cel Reports a Possible Best-in-Class Profile for Adult ALL; Mustang Bio’s MB-106 Reports a 93% ORR in NHL; EHA 2021 Day 3

On the last day of EHA 2021, five key clinical updates were presented from Gilead (Kite), BMS, Autolus, and Mustang Bio. Below, Celltelligence provides insights and context for each presentation.

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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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Comparison of Kymriah’s and Breyanzi’s Efficacy Profile; Gilead Presents Updated Results from Tecartus’s Ph1/2 ZUMA-3 (ALL) and Ph2 ZUMA-2 (MCL) Trials; ASCO 2021 Day 1

On the first day of ASCO 2021, four key clinical updates were presented from Novartis and Gilead. 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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New Gilead-Sponsored Post-Marketing Trial for Tecartus (ZUMA-2 Cohort 3) in R/R MCL

On Monday, May 10, a new post-marketing Tecartus Ph2 ZUMA-2 Cohort 3 trial in r/r MCL was observed on CT.gov. Below, Celltelligence provides insights on the study’s design and how Gilead could leverage this trial to gain a full FDA approval for Tecartus.

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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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GILD: Q1 2021 Earnings Call Summary; JNJ: Cilta-cel MAA Submitted

On Thursday, April 29, Gilead held their Q1 2021 earnings call (press release / presentation), highlighting the rapid recovery of their cell therapy sales revenue, while discontinuing several Yescarta and Tecartus programs. Furthermore, on Friday, April 30, JNJ announced (press release) cilta-cel’s (BCMA CAR-T) MAA submission to the EMA for r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s European expansion to recover and grow market share, while discussing cilta-cel’s potential EU approval timelines.

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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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Gilead Files Tecartus’s sBLA in Adult R/R ALL; AUTO1 Receives PRIME Designation by the EMA; JNJ / Legend Complete Cilta-cel’s Rolling BLA in the US; BMS Files Abecma in Japan for R/R MM; Precision’s New CEO Transition Plan

Ahead of AACR, a series of cell therapy-related news items have been observed:

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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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Yescarta’s Q4 2020 Sales Decline and Kymriah Takes a QoQ Sales Lead for the First Time; Gilead Q4 2020 Earnings Call Summary

On Thursday, February 4, Gilead (Kite) held their Q4 2020 earnings (press release / presentation). Management highlighted the overall increase in revenue for their cell therapy franchise. However, Yescarta’s WW QoQ sales decreased as a result of weak US sales. Below, Celltelligence provides insights on the potential causes for Yescarta’s reduced US revenue and how Gilead may recover market share in the short- to mid-term.

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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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NICE Recommends Tecartus in MCL; First Full Access Deal for Tecartus in Europe

On Tuesday, January 19, NICE announced (press release) that they have agreed to a managed access agreement with Gilead (Kite) for Tecartus (brexucabtagene autoleucel, formerly KTE-X19). Below, Celltelligence provides thoughts on Tecartus’s timely approval by NICE and which EU country could next approve Tecartus for reimbursement.

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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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