Innate Pharma has claimed long-term data from a phase 2 study show its anti-KIR3DL2 antibody has a “sustained effect” against two types of lymphoma.
The French biotech has been evaluating lacutamab in the Tellomak trial of 63 patients with Sézary syndrome (SS), a rare form of the blood cancer, and 107 patients with mycosis fungoides (MF), the most common form of cutaneous T-cell lymphoma.
While the company has not spelled out whether the trial hit its primary endpoints, the biotech will use its presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting that starts in Chicago next week to unveil long-term follow-up data from the study it claimed demonstrate “compelling and sustained clinical activity in heavily pretreated patients.”
Specifically, data taken by Oct. 17 showed objective response rates (ORRs) of 42.9% and 19.6% for the SS and MF cohorts, respectively. The median follow-up time for these groups was 25.1 months and 22.1 months, according to abstracts published ahead of ASCO.
An earlier readout for the SS cohort at around 14 months had showed an ORR of 37.5% for the SS patients, while the readout from around 12 months for the MF patients showed an ORR of 16.8%.
The data published Friday morning also showed a median duration of response of 25.6 months for SS patients and 13.8 months for those with MF, Innate said.
The company’s May 23 release didn’t divulge rates of adverse events, only claiming that lacutamab was “very well tolerated.” This supports “the strong rationale for further investigations” for the drug as a combination treatment beyond cutaneous T-cell lymphoma, “especially in combination with other anti-lymphoma agents in peripheral T-cell lymphomas.”
“The long-term follow-up data from the TELLOMAK clinical study confirms lacutamab’s meaningful clinical benefit in Sézary syndrome and mycosis fungoides and were the basis of the FDA Breakthrough Therapy designation,” Innate Chief Medical Officer Sonia Quaratino, M.D., Ph.D., said in the release.
“We are encouraged by these results and are actively preparing a phase 3 trial in collaboration with health authorities to bring this promising therapy to patients as swiftly as possible,” Quaratino added.
The FDA put the Tellomak trial on hold back in 2023 after Innate revealed a fatal case of hemophagocytic lymphohistiocytosis, a severe systemic inflammatory syndrome, in a patient. After an analysis suggested the death was related to aggressive disease progression, not lacutamab, the agency agreed to lift the hold in January 2024.