The FDA’s decision was based on a quality assessment of a new good manufacturing practice (GMP)-certified batch that was successfully manufactured for the lacutamab clinical development program.
The FDA has lifted the partial clinical hold placed on the TELLOMAK phase 2 clinical trial of lacutamab, according to Innate Pharma, the developer of the agent.
The FDA’s decision was based on a quality assessment of a new good manufacturing practice (GMP)-certified batch that was successfully manufactured for the lacutamab clinical development program, including the TELLOMAK trial. With this announcement, the company may now resume recruitment of new patients in the US with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least 2 prior systemic therapies.
“We are pleased that the FDA has approved the new clinical batch for the TELLOMAK trial, and we can resume enrollment of patients with Sézary syndrome and mycosis fungoides given the importance of novel and effective treatment options needed for these patient populations,” Pierre Dodion, MD, executive vice president and chief medical officer of Innate Pharma, said in a press release. “We’re confident in our ability to supply lacutamab in this important trial moving forward, and look forward to reactivating the trial globally as quickly as possible.”
The global, open-label, multi-cohort TELLOMAK trial is evaluating the efficacy and safety of lacutamab (IPH4102) in the US and Europe in patients with advanced T-cell lymphomas. The trial is anticipated to recruit up to 150 patients, with the agent being evaluated as both a single agent in approximately 60 patients with Sézary syndrome who have received at least 2 prior systemic therapies, including mogamulizumab (Poteligeo), and as a single agent in approximately 90 patients with MF who have received at least 2 systemic therapies.
In patients with MF, the study is designed to assess the benefit of lacutamab according to KIR3DL2 expression. For patients with MF there will be 2 cohorts, testing lacutamab in KIR3DL2 expressing and non-expressing patients. These cohorts will follow a Simon 2-stage design that will terminate if treatment is deemed to be futile.
The Sézary syndrome cohort of the study could facilitate the registration of lacutamab in this indication.
The primary end point of the trial is objective response rate. Key secondary end points include incidence of treatment emergent adverse events (AEs), quality of life (QoL), overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).
The company suggested that they anticipate sharing data from the TELLOMAK trial for MF in 2021 and Sézary syndrome in 2022.
TELLOMAK was previously placed on a partial hold by the FDA due to GMP deficiencies at Innate Pharma’s manufacturing subcontractor site that managed the fill and finish operations of the lacutamab clinical vials for the trial. In Europe, the national regulatory authorities in Spain, Italy, and Germany temporarily halted the trial, while the French and UK regulatory authorities agreed to resume trial recruitment in those respective countries earlier this year. The company indicated that they are currently consulting the regulatory authorities in Germany, Italy and Spain in order to resume the trial in these countries soon.
Lacutamab was previously granted orphan drug status in the EU and in the US for the treatment of cutaneous T-cell lymphoma (CTCL). In January 2019, the FDA granted fast track designation to the company for lacutamab for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least 2 prior systemic therapies.
Innate Pharma news release. U.S. Food and Drug Administration Lifts Partial Clinical Hold on Lacutamab Tellomak Trial in Advanced T-Cell Lymphoma. Published June 24, 2020. innate-pharma.com/en/news-events/press-releases/us-food-and-drug-administration-lifts-partial-clinical-hold-lacutamab-tellomak-trial-advanced-t-cell-lymphomas. Accessed June 24, 2020.