Rezurock Is Approved in Graft vs. Host With More Transplant Agents in Pipeline

When patients receive an organ or tissue transplant, a critical part of their treatment involves therapies that are used to ensure neither their bodies nor the transplanted material rejects the new arrangement. While many first-line treatments given to this patient population are low-cost generics, experts say there is a robust pipeline of treatments in development, including a just-approved treatment for chronic graft vs. host disease (GVHD).

Generally speaking, “maintenance treatment for prevention of organ transplant rejection revolves around immunosuppressive therapy,” explains Arash Sadeghi, a clinical pharmacist at UnitedHealth Group’s OptumRx.

This includes drugs like calcineurin inhibitors (such as tacrolimus and cyclosporine), mTOR inhibitors (including sirolimus and everolimus), antimetabolic agents (e.g., mycophenolate and azathioprine), and glucocorticoids like prednisone, he tells AIS Health, a division of MMIT.

Mesfin Tegenu, R.Ph., president and CEO of RxParadigm, highlights polyclonal antibodies, which include thymoglobulin and atgam, and monoclonal antibodies (rituximab), as other available treatments.

“These agents are generally on formulary; however, there may be variations in tiering,” Tegenu tells AIS Health. “Additionally, formulary positioning for monoclonal and polyclonal antibodies [is] more closely monitored with prior authorizations and placement in [the] specialty tier.”

OptumRx, however, does not have clinical utilization management in place for anti-organ-rejection drugs, according to Sadeghi. Generally, such therapies are generic and inexpensive, he says, a point on which Tegenu agrees.

In addition, such drugs “are included in OptumRx’s Critical Drug Affordability Initiative, which targets critical medication classes for common conditions that do not have clinically appropriate lower cost alternatives and are considered life-sustaining, where lack of access or a short interruption in therapy has a significant clinical risk,” Sadeghi says.

That program limits members’ out-of-pocket costs for anti-organ-rejection therapies to $25 or less. Patients who have had a transplant may also need to take medications to prevent GVHD, which Sadeghi describes as “essentially the inverse of organ transplant rejection.”

With GVHD, he explains, “the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the host’s body. This is in contrast to organ transplant rejection where the recipient’s immune system attacks (rejects) the transplanted organ.”

And the drug pipeline for GVHD is beginning to get interesting. For acute GVHD, agents being studied include an anti-CD6 antibody that prevents T-cell activation and T-cell migration, called alpa-1 antitrypsin, and a double antibody conjugate that is an anti-CD3 and anti-CD7 agent, Tegenu says.

But perhaps most significantly, the FDA on July 16 approved Rezurock (belumosudil) for the treatment of patients 12 years and older who have chronic GVHD and for whom at least two prior systemic therapies have failed. Rezurock targets patients whose cases are more difficult to treat, and it appears to be safe and well tolerated, Tegenu says. There are roughly 14,000 patients with chronic GVHD in the U.S., and they often “cycle rapidly through multiple lines of immunosuppressive therapies” to treat their condition, according to a recent investor presentation from Kadmon Holdings, Inc., which manufactures the small-molecule drug.

Roughly 60% of chronic GVHD patients fail two or more lines of systemic therapy, meaning they could benefit from Rezurock — a first-in-class ROCK2 inhibitor and Kadmon’s first FDA-approved drug. Jakafi (ruxolitinib), which is manufactured by Incyte Corp., and Imbruvica (ibrutinib), produced by Johnson & Johnson and AbbVie Inc., also treat chronic GVHD. Analysts with Mizuho predict Rezurock will generate about $36 million for Kadmon in 2022, FiercePharma reported.

“Other agents in the chronic GVHD pipeline are itacitinib, a JAK1 inhibitor, and leflunomide,” Tegenu adds.

And for different transplant-associated complications, there are additional drugs being developed, notes Sadeghi.

“For instance, narsoplimab is in development for a complication that occurs after transplant called thrombotic microangiopathy,” he tells AIS Health.

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