Tag Archives: Kymriah

Will Yescarta Receive a Positive CHMP Opinion for R/R FL This Week? No Mention of Tecartus or Cilta-cel in November’s CHMP Agenda

On Monday, November 8, the CHMP agenda for November was released. Of note, Yescarta’s (Gilead’s CD19 CAR-T) Type II variation for ≥4L r/r FL is listed as ‘For Adoption’, while no updates were observed for Tecartus (Gilead’s CD19 CAR-T) in r/r adult ALL and cilta-cel (JNJ / Legend’s BCMA CAR-T) in r/r MM. Below, Celltelligence provides likely EU approval timelines for Yescarta, Tecartus, and cilta-cel.

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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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No Cell Therapy Updates in October’s CHMP Highlights

On Friday, October 15, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in October’s CHMP Highlights. Recall that on Wednesday, October 13, 2021, the Celltelligence team prepared a full analysis on October’s CHMP agenda, discussing Breyanzi’s continued regulatory delay and in-depth scenarios for EC approvals of the following cell therapy products (see previous insight):

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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 Breyanzi’s Continuing EU Regulatory Delays; Will Kymriah Receive a Positive CHMP Opinion for R/R FL in December 2021? No Updates for Tecartus, Cilta-cel, and Yescarta in October’s CHMP Agenda

On Monday, October 11, the CHMP agenda for October was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘List of outstanding issues (LoOI)’ section, while Kymriah (Novartis’s CD19 CAR-T) has been listed under ‘Type II variations’ to include ≥3L r/r FL as a new indication. No updates were observed for Tecartus (Gilead’s CD19 CAR-T), cilta-cel (JNJ / Legend’s BCMA CAR-T), or Yescarta (Gilead’s CD19 CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi and Kymriah.

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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 Novartis’s Ph3 BELINDA Trial Failure; Will Novartis Continue Pursuing Kymriah in the 2L DLBCL Setting?

Recently, Novartis reported (press release) that their Ph3 BELINDA study evaluating Kymriah (CD19 CAR-T) in 2L NHL did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis’s trial design could have potentially contributed to BELINDA’s failure, while discussing alternative approaches that Novartis may take to stay in the 2L DLBCL 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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Novartis’s Ph3 BELINDA Trial Fails in 2L NHL; All Eyes on 2L Positive Data for Yescarta and Breyanzi

On Tuesday, August 24, Novartis announced (press release) an update on Kymriah’s (CD19 CAR-T) Ph3 BELINDA trial in 2L NHL. Of note, the BELINDA study did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis could use this opportunity to accelerate Kymriah’s indication in r/r FL, while prioritizing their more novel next-generation CAR-T 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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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.

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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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Yescarta More Cost-Effective Compared to Kymriah but With Higher CRS and NT Rates; Updated Results From Kymriah’s Ph1b PORTIA Trial; POC CD19 CAR-Ts Outperform OOS Kymriah; EHA 2021 Day 1

On the first day of EHA 2021, seven key clinical updates were presented from Novartis, Gilead, the Sheba Medical Center, and the Fred Hutchinson Cancer Center. 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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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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