Tag Archives: Novartis

Yescarta and Kymriah Product Attributes; Early Results from Gracell’s GC502 Ph1 Study in r/r B-ALL; Legend’s LB1901 Ph1 Study Design in r/r TCL; AACR 2022 Analysis 3

AACR 2022 Analysis 3: Several clinical updates were presented by Gilead, Novartis, Gracell, and Legend. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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Kymriah Sales Continue to Decline; Could an Approval in FL Offset Kymriah’s Revenue Loss in DLBCL? Novartis’s Q4 2021 Earnings Call Summary

On Wednesday, February 2, Novartis held their Q4 2021 earnings call (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) quarterly sales decline and regulatory submission in Japan for r/r FL. Below, Celltelligence provides insights on Kymriah’s Q4 2021 revenue, while discussing if Kymriah’s upcoming approvals in r/r FL will be enough to offset declining sales.

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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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Abecma Approved in Japan; Can BMS Meet the Increased Manufacturing Demand? Novartis and Pack Health Explore Digital Coaching to Improve Quality of Life Outcomes Following CAR-T Treatment

On Thursday, January 20, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Abecma (BCMA CAR-T) for the treatment of ≥4L r/r MM. Moreover, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with Novartis and Ohio State University Comprehensive Cancer Center appearing as collaborators. Below, Celltelligence provides insights on Abecma’s potential market access in Japan, while commenting on how the current viral vector shortage could limit BMS’s ability to deliver Abecma in Japan.

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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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Allogene’s FDA Clinical Hold Lifted; JPM 2022 Day 1: BMS, Novartis, JNJ, and Gilead

On Monday, January 10, Allogene (press release) announced that the FDA has lifted the clinical hold on their AlloCAR-T programs. Moreover, on the first day of JPM 2022, Celltelligence covered presentations by BMS (press release / presentation), Novartis (presentation), JNJ (press release), 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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Kymriah Absent From December’s CHMP Highlights

On Friday, December 17, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, no updates from Kymriah’s Type II variation in r/r FL were observed. Below, Celltelligence provides updated likely EU approval timelines for Kymriah, Yescarta, Tecartus, Breyanzi, and Carvykti (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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Novartis May Apply Learnings from BELINDA’s Failure to YTB323 in 2L DLBCL; How Could Novartis Position Their Novel T-Charge Manufacturing Platform in 2L DLBCL and MM Settings? Yescarta’s ZUMA-12 Demonstrates an 89% ORR in 1L DLBCL; ASH 2021 Day 3

On the last day of ASH 2021, 6 clinical updates were presented by Novartis and Gilead (Kite). 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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Novartis’s T-Charge Platform Reduces CAR-T Manufacturing to 2 Days; Novartis’s R&D Day Summary

On Thursday, December 2, Novartis held their R&D day (press release / presentation) highlighting T-Charge, a next-generation CAR-T manufacturing platform that reduces manufacturing time to ~2 days. Moreover, management discussed two novel assets YTB323 (CD19 CAR-T) and PHE885 (BCMA CAR-T) manufactured using the T-Charge platform. Below, Celltelligence provides insights on how Novartis could leverage T-Charge’s rapid manufacturing and potentially lower COGS to position their novel assets within the already crowded DLBCL and MM settings.

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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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Novartis Receives Priority Review for Kymriah in R/R FL

On Wednesday, October 27, Novartis announced (press release) that the FDA has granted Kymriah (CD19 CAR-T) Priority Review in r/r FL. Below, Celltelligence provides insights on Kymriah’s anticipated US approval in ≥3L r/r FL.

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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’s Sales Continue to Decline; Novartis Files Kymriah for R/R FL in the US and EU; Why is Novartis Prioritizing YTB323 in 2L DLBCL? Novartis Q3 2021 Earnings Call Summary

On Tuesday, October 26, Novartis held their Q3 2021 earnings presentation (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) continued sales decline and the US + EU regulatory submissions for Kymriah in r/r FL. Of note, management announced that in 2022, they intend to initiate a registrational trial for YTB323 (next-gen CD19 CAR-T) in 2L r/r DLBCL. Below, Celltelligence provides insights on Kymriah’s Q3 2021 sales revenue, while discussing likely US and EU approval timelines for Kymriah in r/r FL. Finally, Celltelligence outlines why declining Kymriah revenue doesn’t matter for a committed Novartis.

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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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Is Competition from Breyanzi Responsible for a Decline in Kymriah’s Sales? Cilta-cel Remains on Track to Gain FDA Approval by EOY; Novartis and JNJ Q2 2021 Earnings Call Summaries

On Wednesday, July 21, Novartis held their Q2 2021 earnings presentation (press release / presentation) highlighting Kymriah’s sales decline. Of note, no major clinical or regulatory updates were reported. On the same day, JNJ presented their Q2 2021 financial results (press release  / presentation) highlighting the submission of cilta-cel’s (BCMA CAR-T) MAA to the EMA. Below, Celltelligence provides insights on how Breyanzi’s approval in the US could have negatively impacted Kymriah’s Q2 2021 sales while discussing cilta-cel’s potential US and EU regulatory timelines.

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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