{"id":48728,"date":"2022-09-23T07:01:39","date_gmt":"2022-09-23T05:01:39","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/innate-pharma-presents-data-from-ongoing-phase-2-tellomak-trial-demonstrating-clinical-activity-of-lacutamab-in-advanced-mycosis-fungoides\/"},"modified":"2022-09-23T07:01:39","modified_gmt":"2022-09-23T05:01:39","slug":"innate-pharma-presents-data-from-ongoing-phase-2-tellomak-trial-demonstrating-clinical-activity-of-lacutamab-in-advanced-mycosis-fungoides","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/innate-pharma-presents-data-from-ongoing-phase-2-tellomak-trial-demonstrating-clinical-activity-of-lacutamab-in-advanced-mycosis-fungoides\/","title":{"rendered":"Innate Pharma Presents Data From Ongoing Phase 2 TELLOMAK Trial Demonstrating Clinical Activity of Lacutamab in Advanced Mycosis Fungoides"},"content":{"rendered":"
\n

\nPreliminary data set presented at EORTC CLTG annual meeting confirms clinical activity and favorable safety profile of lacutamab in patients with mycosis fungoides who express KIR3DL2 and who were previously treated with at least two lines of systemic therapy<\/i><\/b>\n<\/p>\n

MARSEILLE, France–(BUSINESS WIRE)–Regulatory News:\n<\/p>\n

<\/a><\/p>\n

\nInnate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (\u201cInnate<\/b>\u201d or the \u201cCompany<\/b>\u201d) today announced that lacutamab, an anti-KIR3DL2 antibody, demonstrated clinical responses in patients with mycosis fungoides (MF), in the ongoing Phase 2 TELLOMAK clinical trial.\n<\/p>\n

\nThe results will be shared in an oral presentation at the EORTC CLTG1<\/sup> Annual Meeting, taking place from 22-24 September 2022 in Madrid, Spain, presented by Pr. Martine Bagot, Head of the Dermatology Department, Saint Louis Hospital, Paris.\n<\/p>\n

\nAs of the March 4, 2022 data cutoff, patients in the KIR3DL2-expressing MF patients (cohort 2) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months. In the KIR3DL2 non-expressing cohort (cohort 3), patients received a median of 4.5 prior systemic therapies and had a median follow-up of 13.8 months.\n<\/p>\n

\nResults showed that lacutamab produced a global objective response rate (ORR) of 28.6% (95% confidence interval [CI], 13.8-50.0) in the KIR3DL2-expressing MF patients (n=21), including 2 complete responses and 4 partial responses. Results from the KIR3DL2 non-expressing cohort 3 are also presented.\n<\/p>\n

\n\u201cWe are pleased to see that lacutamab continues to show clinical activity in these heavily-pretreated patients with mycosis fungoides, confirming our hypothesis that lacutamab, a KIR3DL2 targeted agent, could provide benefit to patients with tumors expressing the target,\u201d <\/i>said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma<\/b>. \u201c We look forward to sharing final data from the TELLOMAK Phase 2 trial in both S\u00e9zary syndrome and mycosis fungoides in 2023 and progressing the two additional trials that are ongoing with lacutamab in Peripheral T cell lymphoma.\u201d<\/i>\n<\/p>\n

\n\u201cTreatment options are limited for patients with advanced stage mycosis fungoides, and cutaneous T-cell lymphomas,\u201d <\/i>said Pr. Martine Bagot, Head of the Dermatology Department, Saint Louis Hospital, Paris,<\/b> and investigator in the TELLOMAK study. \u201cThe clinical responses and favorable safety profile observed in the TELLOMAK Phase 2 study, along with the skin responses, make lacutamab a very exciting potential treatment option for the patients. We look forward to the final results of the TELLOMAK study.\u201d<\/i>\n<\/p>\n

\n<\/div>\n

\nSummary of Stage 1 results2<\/sup><\/b>,3<\/b><\/sup>:<\/b>\n<\/p>\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nCohort 2<\/b>\n<\/p>\n

\nKIR3DL2 expressing MF patients<\/b>\n<\/p>\n

\n(n=21)<\/b>\n<\/p>\n<\/td>\n

\n

\nCohort 3<\/b>\n<\/p>\n

\nKIR3DL2 non-expressing MF patients<\/b>\n<\/p>\n

\n(n=18)<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nN prior systemic therapies, median (range)\n<\/p>\n<\/td>\n

\n

\n4 (2-8)\n<\/p>\n<\/td>\n

\n

\n4.5 (2-15)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nGlobal ORR [95% CI]\n<\/p>\n<\/td>\n

\n

\n28.6% [13.8-50.0]\n<\/p>\n<\/td>\n

\n

\n11.1% [3.1-32.8]\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nSkin [95% CI]\n<\/p>\n<\/td>\n

\n

\n57.1% [36.5-75.5]\n<\/p>\n<\/td>\n

\n

\n16.7% [5.8-39.2]\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nBlood [95% CI]\n<\/p>\n<\/td>\n

\n

\n62.5% [30.6-86.3]\n<\/p>\n<\/td>\n

\n

\n25% [4.6-69.9]\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nLymph node [95% CI]\n<\/p>\n<\/td>\n

\n

\n7.7% [1.4-33.3]\n<\/p>\n<\/td>\n

\n

\n0%\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian PFS4<\/sup> [95% CI]\n<\/p>\n<\/td>\n

\n

\n12.0 mo [4.6-15.4]\n<\/p>\n<\/td>\n

\n

\n8.5 mo [4.1-NA]\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPFS at 12mo [95% CI]\n<\/p>\n<\/td>\n

\n

\n53.6% [29.4-72.8]\n<\/p>\n<\/td>\n

\n

\n39.6% [13.6-65.0]\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nIn line with previous observations, lacutamab demonstrated a favorable safety profile in MF also in the skin. Grade \u2265 3 Treatment-related (TR) Treatment-Emergent Adverse events (TEAEs) were observed in 2\/39 (5.1%) pts and 1\/39 (2.6%) patients discontinued study drug due to adverse events. Most common TR TEAEs were asthenia (N=5, 12.8%), arthralgia (N=4, 10.3%), and nausea (N=3, 7.7%).\n<\/p>\n

\nAbout Lacutamab:<\/b>\n<\/p>\n

\nLacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages.\n<\/p>\n

\nKIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, S\u00e9zary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.\n<\/p>\n

\n<\/div>\n

\nAbout TELLOMAK:<\/b>\n<\/p>\n

\nTELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with S\u00e9zary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:\n<\/p>\n