pharmaphorum.com
Bristol-Myers Squibb is on course to move its BCMA-targeting CAR-T therapy further up the treatment pathway in multiple myeloma, after reporting that it met its objectives in a phase 3 trial.
2seventy bio-partnered Abecma (idecabtagene vicleucel) is already approved as a fourth-line or later therapy for the blood cancer, and the KarMMa-3 study is designed to support second or third-line treatment with the CAR-T.
BMS and 2Seventy have revealed that Abecma achieved an improvement compared to standard care on progression-free survival (PFS), and say they now plan to submit the trial data quickly to regulators in the hope of making the therapy available to earlier-stage myeloma patients.
Overall survival data isn't mature yet, and the full results of the study won't be divulged until later this year. Safety meanwhile was also encouraging and in line with earlier trials of Abecma, according to a company statement, alleviating concerns that earlier treatment with fitter T cells may translate to more toxicity.
https://twitter.com/bradloncar/status/1557421226359914502
Nevertheless, the readout keeps Abecma a step ahead of its nearest challenger – Johnson & Johnson and Legend Biotech's Carvykti (ciltacabtagene autoleucel) – which was approved by the FDA as a fourth-line or later option for multiple myeloma therapy earlier this year based on the CARTITUDE-1 data.
Despite reaching the market around a year after Abecma, Carvykti has strong data to back it up, and a number of analysts who think it could be a strong challenger to Abecma, with preliminary data from the CARTITUDE-2 trial showing food safety and efficacy as second-line therapy.
For its part, Abecma made $89 million in the second quarter, up 36% on the previous quarter with the increase driven by "expanded capacity and vector supply," according to BMS.
William Blair analyst Matt Phipps has estimated that there are around 3,000 multiple myeloma patients in the US who get fifth-line treatment per year.
That rises to 6,000 for fourth-line therapy and 12,000 to 13,000 for third-line, so the eligible patient population will increase dramatically if BMS can secure FDA approval.
"Results from the KarMMa-3 study clearly demonstrate the clinical benefit of using a CAR T cell therapy earlier in the multiple myeloma treatment paradigm," commented Anne Kerber, BMS' head of cell therapy development.
"These data reinforce our commitment to unlocking the full potential of cell therapy as we strive to build on the company's heritage of innovation in blood cancers and transform patients' lives through science."