Bristol Myers Squibb nabs priority review tag for $3.15B arthritis drug Orencia to prevent transplant rejection

Bristol Myers Squibb just got some good news on its quest to transform aging arthritis med Orencia into a preventive therapy for transplant rejection.

The FDA has blessed abatacept—approved as Orencia in rheumatoid arthritis since 2005—with a priority review tag for approval to prevent moderate-to-severe acute graft-versus-host disease (aGvHD).

The drug is bound for a Dec. 23 decision date and, if it passes muster with the FDA, would be cleared for patients ages six and up receiving hematopoietic stem cell transplants from unrelated donors.

Stem cell transplants include infusions of donor T cells, which are used to attack cancer cells. In GvHD patients, though, donor T cells can take aim at healthy tissues and organs.

AGvHD crops up in 30% to 70% of transplant patients, based on donor type, transplant technique and other factors. BMS believes Orencia could help stymie transplant rejection by binding to and inhibiting proteins involved in co-stimulation—a signaling process that queues up T cells to attack.

Bristol Myers’ application included data from Orencia’s mid-stage ABA2 study, plus a registry trial based on real-world evidence. Orencia patients in ABA2 saw a “significant reduction” in severe aGvHD and related morbidity, while disease relapse rates remained level, BMS said. The real-world analysis yielded results “consistent” with those from ABA2, the company said.

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ABA2 broke patients down into two cohorts: the first group included blood cancer patients getting transplants from human leukocyte antigens (HLA) mismatched, unrelated donors. The second, placebo-controlled cohort was composed of blood cancer patients receiving transplants from HLA-matched, unrelated donors. An HLA mismatch increases the risk of transplant rejection, BMS noted.

Patients on Orencia got a 10 mg/kg dose at four points throughout the study period. All subjects were given a standard of care calcineurin inhibitor plus methotrexate.

Adding Orecnia to that standard transplant rejection regimen led to a “significantly higher aGvHD-free survival rate” versus registry controls in the drug’s single-arm, HLA-matched cohort. The Orencia-standard-of-care combo had a numerically higher rejection-free survival rate in the placebo-controlled, HLA-matched arm 180 days post-transplant.

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In arthritis, Orencia continues to pull its weight. The drug ginned up around $3.15 billion in 2020, Bristol said in its annual report. So far in 2021, Orencia has reeled in $758 million for the first three months of the year and $814 million in the second quarter, according to the company's earnings updates. 

Meanwhile, the drug was tapped by the National Institutes of Health last year for a phase 3 study to see whether it and another pair of immune modulator drugs could be repurposed to control immune overreactions in moderate-to-severe COVID-19 patients.

Back in the transplant rejection arena, the FDA in July approved Kadmon’s Rezurock to treat chronic graft-versus-host, putting the company on the path to launch its first-ever commercial product. Kadmon at the time said it aimed to make the drug available by the end of August. 

Meanwhile, the regulator recently delayed a decision on Incyte's Jakafi in steroid-refractory chronic GVHD to provide more time to review additional data. The Jak inhibitor is now up for a decision Sept. 22.