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Sagar S. Patel, MD, discusses data from trials evaluating agents in the Orca platform and where they fit into hematologic malignancy treatment paradigms.
Highly anticipated clinical trials and improvements in graft-vs-host disease (GVHD) management across several patient subgroups surround Orca products like Orca-T and Orca-Q for use in patients with hematologic malignancies, according to Sagar S. Patel, MD.
In an interview with OncLive®, Patel touched on evidence from trials evaluating Orca-T and Orca-Q, where Orca-T may fit into the hematologic malignancy treatment paradigm following its anticipated approval, plans for the future development of Orca-Q, and for which patient populations the platform may hold the most promise.
Patel first underscored role of the phase 2 SERENE-T trial (NCT07216443), which is currently undergoing enrollment and is evaluating Orca-T following reduced-intensity conditioning (RIC) or nonmyeloablative conditioning in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).1 Data from the trial will be crucial in determining how wide the net of Orca-T applications can be cast, Patel added.
Patel also highlighted data with Orca-Q in patients with high-risk hematologic malignancies from a
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Patel is an associate professor of internal medicine in the Division of Hematology & Hematologic Malignancies at the University of Utah Huntsman Cancer Institute in Salt Lake City.
Ongoing Developments for Orca-T and Orca-Q in Hematologic Malignancies
Patel: This is a natural evolution based on the success of the original Orca-T platforms, which were primarily focused on using a myeloablative regimen for myeloid diseases. We’ve seen such positive data to date across the various prospective studies with Orca-T, [such as] Precision-T. SERENE-T is a follow-up, multicenter, open-label study that will look at the use of this same [Orca-T] platform, but now in a reduced-intensity and non-myeloablative context.
[The SERENE-T outcomes are] going to be key for patients who are potentially older, where we’re often reaching for [a higher] level of intensity. This [trial is] restricted to patients with AML and MDS. This will be a nice way for us to continue to see the broader application expansion of this Orca platform.
If [Orca-T] becomes approved, it will be a big change [compared with] the typical menu of options we’ve had as allogeneic transplanters. The ability to use a single agent for GVHD prophylaxis and elicit upfront graft manipulation to significantly reduce rates of GVHD is attractive. Even though we’ve gotten better at managing GVHD, it's still a disease associated with significant morbidity and mortality. [Thus], efforts to prevent or reduce the incidence and severity of it are welcome. [The approval of Orca-T] will be attractive on a large scale.
The Orca-Q platform is used in the haploidentical setting. We are doing increasingly larger numbers of [haploidentical transplants] since not all of our patients have access to a matched-related or matched-unrelated donor. [In a phase 1 trial (NCT03802695)], the Orca-Q platform in the haploidentical donor setting yielded high engraftment rates and low incidences of severe, acute, and chronic GVHD. [These data] support the safety and efficacy of Orca-Q in reducing GVHD without the compromise of potential relapse. This early-phase study is well poised for subsequent follow-up in a larger prospective study for evaluation of the efficacy [of Orca-Q] compared with standards of care.
