FDA PDUFA DATE 12/16/23 For IND + Poster presentation Tomorrow at ASH Conference!
$2seventy bio (TSVT.US)$ SELECTED ABECMA DATA TO BE PRESENTED AT ASH
Oral Presentation: Idecabtagene Vicleucel (ide-cel) Versus Standard Regimens in Patients (pts) with Triple-Class Exposed (TCE) Relapsed and Refractory Multiple Myeloma (RRMM): Updated Analysis from KarMMa-3
Presenter: Paula Rodriguez-Otero
Date & Time: Monday, December 11, 4:45pm PT
In the final progression-free survival (PFS) analysis from the Phase 3 KarMMa-3 study in patients with RRMM who received 2-4 prior regimens, significantly longer PFS was maintained with ide-cel versus standard regimens. In pts who received ide-cel (n = 225) or a standard regimen (n = 126), median PFS (95% CI) was 15.7 (12.5–18.9) vs 4.4 (3.4–5.8) months, respectively. The ide-cel safety profile was consistent with previous reports, with no parkinsonism or Guillain–Barré syndrome reported. Ide-cel continued to demonstrate durable, clinically meaningful improvements in pt-reported outcomes, including symptoms, functioning, and quality of life (QOL) vs standard regimens. Interim overall survival (OS) will be included in the presentation.
Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron, anticipated by end of 2023.
•Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023.![]()
Oral Presentation: Idecabtagene Vicleucel (ide-cel) Versus Standard Regimens in Patients (pts) with Triple-Class Exposed (TCE) Relapsed and Refractory Multiple Myeloma (RRMM): Updated Analysis from KarMMa-3
Presenter: Paula Rodriguez-Otero
Date & Time: Monday, December 11, 4:45pm PT
In the final progression-free survival (PFS) analysis from the Phase 3 KarMMa-3 study in patients with RRMM who received 2-4 prior regimens, significantly longer PFS was maintained with ide-cel versus standard regimens. In pts who received ide-cel (n = 225) or a standard regimen (n = 126), median PFS (95% CI) was 15.7 (12.5–18.9) vs 4.4 (3.4–5.8) months, respectively. The ide-cel safety profile was consistent with previous reports, with no parkinsonism or Guillain–Barré syndrome reported. Ide-cel continued to demonstrate durable, clinically meaningful improvements in pt-reported outcomes, including symptoms, functioning, and quality of life (QOL) vs standard regimens. Interim overall survival (OS) will be included in the presentation.
Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron, anticipated by end of 2023.
•Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023.
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Jaguar8 : This is interesting tomorrow AH. But I’ll enter before haha
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