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Innate drops monotherapy plans for lymphoma med lacutamab 2 months after FDA lifts hold

Just two months after the FDA lifted a clinical hold on trials of Innate Pharma’s lymphoma drug, the biotech has now dropped plans to pursue the anti-KIR3DL2 antibody as a monotherapy for a specific form of that cancer.

The French drug developer has been investigating the potential of lacutamab to treat both cutaneous T cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL). In October, Innate revealed a fatal case of hemophagocytic lymphohistiocytosis, a severe systemic inflammatory syndrome, in a patient in the phase 2 CTCL study that prompted the FDA to impose a partial hold on studies of lacutamab. 

After an analysis suggested the death was related to aggressive disease progression, not the study drug, the agency agreed to lift the hold in January.

But now it sounds like lacutamab’s PTCL program has run into problems. Despite “objective responses observed,” Innate has decided not to reopen the phase 1b trial evaluating lacutamab as a monotherapy for PTCL.

“The prespecified threshold for meaningful clinical activity was not reached,” the biotech explained in a full-year earnings report this morning.

It’s not the end of the road for lacutamab in PTCL, however. Innate said a phase 2 trial of the antibody in combination with the chemotherapy GEMOX—a combination of gemcitabine and oxaliplatin—is ongoing.

Preclinical data presented at last year’s American Society of Hematology conference showed a “synergistic effect between lacutamab and chemotherapy” that supported the “rationale for combination strategy in this clinical indication,” Innate added.

Innate shared phase 2 data for lacutamab in Sézary syndrome, a type of CTCL, at the same conference. The biotech expects to read out mid-stage data on patients with mycosis fungoides, another type of CTCL, later this year. Talking to investors in December 2023, Chief Medical Officer Sonia Quaratino said the plan is to talk to the FDA once the mycosis fungoides data are in.

The Marseille-based biotech entered 2024 with cash, equivalents and assets amounting to 102.3 million euros ($111.6 million). This should pave a cash runway to the end of 2025, said interim CEO Hervé Brailly, Ph.D., who also used his statement to highlight the company’s recent Big Pharma collaborations.

“We reported positive data with lacutamab in Sézary syndrome, began phase 1 testing of our proprietary, second-generation ANKET IPH6501 and secured further validation of our ANKET platform with Sanofi having licensed four ANKET candidates for hematologic malignancies and solid tumors,” Brailly said.

“The phase 3 trial for monalizumab in non-small lung cancer that is being led by AstraZeneca continues to advance,” the CEO added. “Looking ahead to 2024, we expect notable milestones including final results from the TELLOMAK phase 2 trial with lacutamab in mycosis fungoides, and progressing our first proprietary ADC program, IPH45, towards an IND filing.”

https://www.fiercebiotech.com/biotech/innate-drops-monotherapy-plans-lacutamab-type-lymphoma-2-months-after-fda-lifts-hold

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