2seventy bio, Bristol Myers end late-stage Abecma study in multiple myeloma

2seventy bio and its partner Bristol Myers Squibb said Wednesday that they are discontinuing enrollment in the Phase 3 KarMMa-9 study investigating Abecma in patients with newly diagnosed multiple myeloma.

2seventy CEO Chip Baird wrote in a statement that the decision was made after a “rigorous review of the business case for the KarMMa-9 study” and that there’s been a “greatly improved” treatment landscape in the newly diagnosed setting.

Chip Baird

In a separate release, Bristol Myers added there were enrollment difficulties as there were fewer eligible patients for the study due to “the evolution of more intense and prolonged induction therapies.” The trial has been open for over a year in 18 countries but only 10% of the study population has been accrued so far, the company added. The trial had a target of 618 patients, according to ClinicalTrials.gov.

For its part, the trial discontinuation would help 2seventy break even next year.

“Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over $80 million in near-term expenditures and accelerate our path to breakeven in 2025,” Baird added.

2seventy and Bristol Myers were evaluating the CAR-T therapy in the trial alongside lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who had a suboptimal response to an autologous stem cell transplant.

The companies scored an expanded approval from the FDA for Abecma in April in the third-line setting, following its initial approval in fifth-line patients, despite concerns over a higher rate of death in early treatment among patients who took the drug compared to those who received standard regimens.

“Abecma continues to show encouraging signs of growth with an expanded label in the third line and a differentiated safety profile,” Baird added.

In its Tuesday announcement, 2seventy wrote that it expects 2024 third-quarter Abecma revenue growth in the US of around 30% from second-quarter revenue of $54 million.