Innate secures speedy resolution of FDA hold on lymphoma trials ahead of key regulatory talks

Innate secures speedy resolution of FDA hold on lymphoma trials ahead of key regulatory talks

Innate Pharma has begun the new year with a spring in its step, sharing news that the FDA has lifted the partial hold on lymphoma clinical trials that was imposed last year in response to the death of a patient.

In October, Innate revealed a fatal case of hemophagocytic lymphohistiocytosis (HLH), a severe systemic inflammatory syndrome, had prompted the FDA to impose a partial hold on studies of the anti-KIR3DL2 antibody lacutamab. The FDA asked Innate to adopt risk mitigation and management strategies to limit the risk of more patients suffering HLH.

As Innate discussed on calls with investors last year, an analysis of the case, which the biotech carried out with independent experts, suggested the death was related to aggressive disease progression, not the study drug. The work has led to the lifting of the partial clinical hold.

Resolving the hold within two months mitigated the impact of the regulatory action. The partial hold stopped Innate from recruiting new patients in studies but by then the biotech had already fully enrolled its cutaneous T-cell lymphoma (CTCL) phase 2 and the initial cohort of its peripheral T cell lymphoma phase 1.

Innate shared phase 2 data in Sézary syndrome, a type of CTCL, late last year. At the time, the biotech said it expected to have phase 2 data on patients with mycosis fungoides, another type of CTCL, by the end of the year and share the results in the near future. Talking to investors last month, Sonia Quaratino, chief medical officer at Innate, said the plan is to talk to the FDA once the mycosis fungoides data are in.

“Any accelerated approval must present a confirmatory trial, and we will discuss with the FDA around the study design, the patient population that is going to be part of the study design, whether it’s Sézary plus mucositis fungoides or Sézary alone and the comparator arm. This is something that we will be able to define only after we [have] had this interaction next year,” Quaratino said.

The choice of comparator arm is one key outstanding question. Innate’s phase 2 trial enrolled patients who had progressed after taking Kyowa Kirin’s Poteligeo and at least one other systemic therapy. On the Innate phase 2 data call last month, Jefferson Health’s Pierluigi Porcu, M.D., said “the complexity here is going to be the selection of a comparator that is going to be meaningful in [the] patient population.”

Shares in Innate rose 8.33% to 2.73 euros ($2.99) after the FDA lifted the hold Thursday.

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