Tag Archives: CD19 CAR-T

Yescarta Reimbursement in Japan Matched to Kymriah’s Latest Price Adjustment; Will Breyanzi be Priced Similarly?

On Wednesday, April 21, Japan’s Ministry of Health, Labor, and Welfare (MHLW) listed Yescarta (Gilead) in the NHI’s reimbursement price list (press release, PharmaJapan, Apr 2021). Below, Celltelligence provides thoughts on Japan’s pricing for Yescarta and Kymriah and how this could impact Breyanzi’s (BMS) reimbursement discussions.

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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 Reports Innovative Biomarkers Associated with Clinical Outcomes in the Ph2 ZUMA-5 Trial; Carl June Explores Novel Approaches to Improve CAR-T Function; IL-2 Makes a Comeback with OrthoCARs; AACR 2021 Day 3

On the third day of AACR 2021 Week I, key clinical / preclinical updates were reported from Gilead (Kite) and Synthekine, while Carl June presented an overview of CAR-T engineering tools to improve efficacy and safety outcomes. 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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Breyanzi Approved in Japan; but What’s the Price?

On Monday, March 22, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Breyanzi (CD19 CAR-T) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), transformed low-grade NHL, and high-grade B-cell lymphoma (press release). Below, Celltelligence provides insights on Breyanzi’s market access in Japan, while commenting on Breyanzi’s potential pricing and manufacturing strategies compared to key competitors Kymriah (Novartis) and Yescarta (Gilead).

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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 Kymriah’s Approval in Singapore; Could Singapore Become a Hub for Cell Therapy Medical Tourism in Southeast Asia?

On Tuesday, March 9, Novartis received approval (press release, PR Newswire, Mar 2021) for Kymriah (CD19 CAR-T) in pediatric r/r ALL and adult r/r DLBCL by Singapore’s Health Sciences Authority (HSA). Of note, Kymriah is now the first commercially approved CAR-T therapy in the region. Below, Celltelligence provides insights on how Novartis could leverage Kymriah’s approval in Singapore to expand within the Asia-Pacific market, Singapore’s pivot towards cell therapy manufacturing, and how BMS and Gilead compare in the region.

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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 Receives Broader FL Label Than Breyanzi; MZL Not Granted in Yescarta’s ZUMA-5 Accelerated Approval

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated approvals and submissions following Gilead’s (Kite) announcement (see below for download).

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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 Academic CD19 CAR-T ARI-0001 Ph2 Trial in R/R ALL Posted

On Wednesday, March 3, a new ARI-0001 (autologous CD19 CAR-T) Ph2 trial (CART19-BE-02) was observed on CT.gov for the treatment of adult r/r ALL. Below, Celltelligence provides details for this trial and how ARI-0001’s point-of-care (PoC) model could potentially be replicated in other countries if proven successful.

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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’s Median Time to CRS Improved by Prophylactic Corticosteroid Use; Thoughts on Frank Neumann Joining Kite as Worldwide Head of Clinical Development

On Wednesday, February 10, Gilead (Kite) announced (press release / abstract) updated results from cohort 6 of the Ph1/2 ZUMA-1 trial. The analysis showed that prophylactic use of corticosteroids has the potential to delay Yescarta’s CRS onset. Additionally, Gilead announced (press release) that Frank Neumann has joined Kite as Senior Vice President and Global Head of Clinical Development. Below, Celltelligence provides insights on how Yescarta’s improved safety profile could bring CRS onset parity with Breyanzi and if Kite’s recent senior management appointments could suggest a reprioritization towards solid tumors.

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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 First Commercial Manufacturing Facility Approved in Australia; Novartis Increases Manufacturing Footprint to Six Global Centers

On Friday, February 12, Novartis announced (press release) that the Peter MacCallum Cancer Center in Melbourne has been approved by the Therapeutic Goods Administration (TGA) to commercially manufacture Kymriah. Below, Celltelligence provides thoughts on the impact of Novartis’s manufacturing footprint strategy and anticipated manufacturing approval in China.

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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 Breyanzi’s (liso-cel) Label, Price, Manufacturing, and TAT Compared to Kymriah and Yescarta

On Friday, February 5, BMS announced (press release) that the FDA approved Breyanzi (lisocabtagene maraleucel) for the treatment of r/r LBCL after ≥2L systemic therapy, which is essentially ≥3L r/r DLBCL. The application was based on data from the Ph1 TRANSCEND NHL 001 trial. Below, Celltelligence provides insights on Breyanzi’s approval, the higher DLBCL list price vs. Kymriah and Yescarta, how BMS may position Breyanzi in the CD19 CAR-T setting, why supplying Breyanzi in vials is strategically important, and a look at the Breyanzi mobile app.

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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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