Category Archives: BCMA

Carvykti Sales Flatten while Preparing for Launch in 2L MM; JNJ’s Q1 2024 Earnings Call Summary

On Tuesday, April 16, JNJ held its Q1 2024 earnings call (press release / presentation) mentioning Carvykti’s (BCMA CAR-T) revenue remained approximately flat. Additionally, management remarked on Carvykti approval by the FDA and the CHMP positive opinion for the treatment of 2L MM patients. Below, Celltelligence provides insights on Carvykti’s underperforming revenue during this quarter while discussing its upcoming launch in 2L MM.

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Carvykti and Abecma Receive FDA Approval for Early Lines of MM

On Friday, April 5, JNJ (press release) and Legend (press release) announced that the FDA approved Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

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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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You May Have Missed: New Breyanzi Ph3 Trial for R/R FL; Abecma Approved for 3L MM in the EU

In the past week, the Celltelligence team detected relevant news that was not discussed in individual blasts but worth highlighting. In this blast, Celltelligence will cover the following topics:

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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 the FDA ODAC Recommending Carvykti and Abecma in Earlier Lines of MM

On Friday, March 15, JNJ (press release) and Legend (press release) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide.

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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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Caribou to Provide Updated Timeline for the Initiation of CB-010’s Trial in 2L LBCL in Q2 2024; First Patient Dosed in CB-012’s AmpLify Trial; Caribou Q4 and FY 2023 Earnings Summary

On Monday, March 11, Caribou released its Q4 and FY 2023 results (press release) highlighting that an updated timeline for the initiation of CB-010’s (allogeneic CD19 CAR-T) pivotal Ph3 trial in ≥2L LBCL is expected in Q2 2024 while noting that the first patient has been dosed in the Ph1 AMpLify trial evaluating CB-012 (allogeneic CLL-1 CAR-T) in ≥4L MM. Of note, the company has paused the development of CB-020 (allogeneic ROR-1 CAR-iNK) as part of a regular portfolio prioritization process.

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Poseida to Present Updated Clinical Results at AACR 2024; Legend Further Expands its Manufacturing Capacity; Poseida and Legend Q4 2023 Earnings Call Summary

On Thursday, March 7, Poseida released its Q4 and FY 2023 business updates (press release) highlighting clinical results from its lead asset P-BCMA-ALLO1’s (allogeneic BCMA CAR-T) Ph1 trial in r/r MM and an initial readout from its P-MUC1C-ALLO1’s Ph1 trial in advanced or metastatic solid tumors will be presented at AACR 2024.

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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 US Revenue Continues to Decrease; 2seventy Bio’s Q4 2023 Earnings Call

On Tuesday, March 5, 2seventy bio held its Q4 and FY 2023 earnings call (press release / webcast) acknowledging the decline in Abecma (BMS / 2seventy bio’s BCMA CAR-T) sales in the US. Below, Celltelligence provides insights on the reasons behind the Abecma revenue decrease, while commenting on the future opportunities for the BCMA CAR-T upon its potential approval in ≥3L MM.

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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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Arcellx / Gilead to Include BCMA-Relapsed Patients in Early Line MM Trials; Arcellx’s Q4 2023 Results Summary

On Thursday, February 28, Arcellx released its Q4 and FY 2023 results (press release) highlighting the recent expansion of the partnership agreement with Gilead (Kite). Moreover, as disclosed in a SEC filing, the companies are planning to include patients who have received prior BCMA-targeted treatments to support anito-cel’s label expansion into earlier MM lines while initiating additional clinical trials ex-US.

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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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CHMP Adopts Positive Opinion for Carvykti in ≥2L MM; February CHMP Highlights

On Friday, February 23, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM.

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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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Could Carvykti Receive a Positive Opinion in Q1 2024? February CHMP Agenda

On Monday, February 19, the CHMP agenda for February was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM.

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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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