Fri, 05/23/2025 - 07:00

2025年5月23日，星期五，07:00

Long term follow-up data from the TELLOMAK Phase 2 trial in Sézary syndrome (SS) and mycosis fungoides (MF) will be presented at the ASCO Annual Meeting 2025.

TELLOMAK 2期试验中关于塞扎里综合征（SS）和蕈样真菌病（MF）的长期随访数据将在2025年ASCO年会上公布。

Long-term follow-up data from TELLOMAK study confirms the meaningful clinical activity in heavily pretreated SS patients with a global overall response rate (ORR) of 42.9% and an impressive median duration of response of 25.6 months.

TELLOMAK研究的长期随访数据证实，在经过多线治疗的SS患者中具有显著的临床活性，全球总体缓解率（ORR）为42.9%，中位缓解持续时间长达25.6个月，令人印象深刻。

Data also confirms meaningful activity in heavily pretreated MF patients with a global ORR of 19.6% and confirms that the anti-tumor activity is observed in all patients (KIR3DL2 ≥1% or < 1% at baseline).

数据还证实了在经过多线治疗的MF患者中存在显著的活性，全球总体缓解率（ORR）为19.6%，并证实抗肿瘤活性在所有患者中均能观察到（基线时KIR3DL2 ≥1%或<1%）。

These compelling data, in a patient population with multiple prior systemic treatments strongly support the development of lacutamab for MF and SS.

这些在有多次既往系统治疗经历的患者群体中获得的令人信服的数据，强烈支持将Lacutamab用于MF和SS的开发。

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“

Innate Pharma SA（巴黎泛欧交易所代码：IPH；纳斯达克代码：IPHA）（“

Innate

先天的

” or the “

” 或 “

Company

公司

”) today announced the presentation of long-term follow-up data from the Phase 2 TELLOMAK clinical trial evaluating lacutamab, an anti-KIR3DL2 monoclonal antibody, in patients with Sézary syndrome (SS) and mycosis fungoides (MF), two rare and aggressive forms of cutaneous T-cell lymphoma (CTCL). The results will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, in Chicago, Illinois..

”)今天宣布了来自评估拉库单抗（一种抗KIR3DL2单克隆抗体）的二期TELLOMAK临床试验的长期随访数据，该试验针对塞扎里综合症（SS）和蕈样霉菌病（MF）患者，这两种疾病是罕见且侵袭性的皮肤T细胞淋巴瘤（CTCL）形式。结果将在2025年于伊利诺伊州芝加哥举行的美国临床肿瘤学会（ASCO）年会上展示。

Lacutamab was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Sézary syndrome, underscoring its potential to address critical needs in advanced CTCL.

Lacutamab最近被美国食品药品监督管理局（FDA）授予突破性疗法认定，用于治疗 Sézary 综合征，凸显了其在满足晚期CTCL关键需求方面的潜力。

As of October 17, 2024, data cut-off, lacutamab demonstrated compelling and sustained clinical activity in heavily pretreated patients, with a global ORR of 42.9% for SS and 19.6% for MF. With longer follow-up, we observed improved median duration of response of 25.6 months in SS and 13.8 months in MF, highlighting the durability of responses in these challenging indications.

截至2024年10月17日的数据截止，lacutamab在经过多线治疗的患者中显示出显著且持续的临床活性，SS的全球客观缓解率（ORR）为42.9%，MF为19.6%。随着更长的随访时间，我们观察到SS的中位缓解持续时间提升至25.6个月，MF为13.8个月，突显了在这两个具有挑战性的适应症中的持久缓解效果。

1

1

.

。

In addition, lacutamab was very well tolerated supporting the strong rationale for further investigations in combination beyond CTCL, especially in combination with other anti-lymphoma agents in peripheral T-cell lymphomas (PTCL).

此外，拉库单抗的耐受性非常好，这为进一步在CTCL之外的联合治疗研究提供了强有力的理由，特别是在外周T细胞淋巴瘤（PTCL）中与其他抗淋巴瘤药物联合使用。

“

“

Patients with advanced mycosis fungoides and Sézary syndrome often face a poor prognosis and limited treatment options after multiple prior lines of therapy,

晚期蕈样真菌病和塞扎里综合症患者在多轮前期治疗后，通常面临预后不良和治疗选择有限的情况，

” said

“说

Prof. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia and principal investigator of the TELLOMAK trial

Pierluigi Porcu教授，血液系统恶性肿瘤及造血干细胞移植科主任，西德尼·金梅尔癌症中心，杰斐逊健康（费城），TELLOMAK试验的首席研究员

. “

“

The durability and depth of responses observed with lacutamab in this study are highly promising and represent a significant advancement for this patient population

本研究中观察到的拉库单抗的反应持久性和深度非常令人鼓舞，代表了这一患者群体的重大进步。

.”

“。”

“

“

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. 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,.

TELLOMAK临床研究的长期随访数据证实了lacutamab在 Sézary综合征和蕈样霉菌病中的显著临床益处，这也是FDA突破性疗法认定的基础。我们对这些结果感到鼓舞，并正在与卫生当局积极合作准备第三阶段试验，以尽快将这种有前景的疗法带给患者。

” added

“已添加

Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma

Innate Pharma首席医学官Sonia Quaratino博士

.

。

1  Compared to results previously presented at

1  与之前展示的结果相比

ASH 2023

ASH 2023

and

和

ASCO 2024

ASCO 2024

.

。

Efficacy results in SS patients (Data cut-off: OCT 17, 2024)

SS患者中的疗效结果（数据截止：2024年10月17日）

Best Response

最佳回应

Global

全局

N=63

N=63

in Skin

皮肤

N=63

N=63

in Blood

血液中

N=63

N=63

in Lymph Nodes

在淋巴结中

N=52*

N=52*

CR (complete response), N (%)

CR（完全缓解），N（%）

6 (9.5)

6 (9.5)

9 (14.3)

9 （14.3）

21 (33.3)

21 (33.3)

9 (17.3)

9 (17.3)

PR (partial response), N (%)

部分缓解（PR），N (%)

21 (33.3)

21 (33.3)

24 (38.1)

24 (38.1)

11 (17.5)

11（17.5）

6 (11.5)

6 (11.5)

SD (stable disease), N (%)

SD（疾病稳定），N（%）

28 (44.4)

28 (44.4)

27 (42.9)

27 (42.9)

26 (41.3)

26 (41.3)

27 (51.9)

27 (51.9)

PD (progressive disease), N (%)

PD（疾病进展），N（%）

8 (12.7)

8（12.7）

3 (4.8)

3 (4.8)

5 (7.9)

5 (7.9)

6 (11.5)

6（11.5）

NE (not evaluable), N (%)

无法评估，N (%)

0

0

0

0

0

0

4 (7.7)

4 (7.7)

ORR, % [95% CI]

客观缓解率，% [95% 置信区间]

42.9

42.9

[31.4-55.1]

[31.4-55.1]

52.4

52.4

[40.3-64.2]

[40.3-64.2]

50.8

50.8

[38.8-62.7]

[38.8-62.7]

28.8

28.8

[18.3-42.3]

[18.3-42.3]

Time to response, months, median (range)

响应时间，月数，中位数（范围）

2.8 (1-10)

2.8（1-10）

DoR, months, median [95% CI]

持续缓解时间，月，中位数 [95% 置信区间]

25.6

25.6

[11.0 – NE]

[11.0 – NE]

PFS, months, median [95% CI]

PFS，月，中位数 [95% CI]

8.3

8.3

[5.1-18.7]

[5.1-18.7]

Efficacy results in MF patients (Data cut-off: OCT 17, 2024)

MF患者中的疗效结果（数据截止日期：2024年10月17日）

Best Response

最佳响应

All MF

所有 MF

N=107

N=107

KIR3DL2 ≥1%

KIR3DL2 ≥1%

N=48

N=48

KIR3DL2 <1%

KIR3DL2 <1%

N=59

N=59

CR (complete response), N (%)

完全缓解（CR），N（%）

3 (2.8)

3 (2.8)

3 (6.3)

3 (6.3)

0 (0.0)

0 (0.0)

PR (partial response), N (%)

部分缓解（PR），N（%）

18 (16.8)

18 (16.8)

7 (14.6)

7 （14.6）

11 (18.6)

11（18.6）

SD (stable disease), N (%)

疾病稳定（SD），N（%）

71 (66.4)

71（66.4）

30 (62.5)

30 (62.5)

41 (69.5)

41（69.5）

PD (progressive disease), N (%)

PD（疾病进展），N（%）

13 (12.1)

13 (12.1)

6 (12.5)

6 (12.5)

7 (11.9)

7 (11.9)

ORR (Objective Response Rate), % [95%CI] Olsen 2011

ORR（客观缓解率），% [95%CI] Olsen 2011

19.6 [13.2, 28.1]

19.6 [13.2, 28.1]

20.8 [11.7, 34.3]

20.8 [11.7, 34.3]

18.6 [10.7, 30.4]

18.6 [10.7, 30.4]

ORR, % [95%CI] Olsen 2022

ORR，% [95%CI] Olsen 2022

24.3 [17.2, 33.2]

24.3 [17.2, 33.2]

29.2 [18.2, 43.2]

29.2 [18.2, 43.2]

20.3 [12.0, 32.3]

20.3 [12.0, 32.3]

Time to response, months, median (range)

响应时间，月，中位数（范围）

2.8 (1-37)

2.8 (1-37)

1.0 (1-5)

1.0（1-5）

2.8 (1-37)

2.8 (1-37)

DoR, months, median [95% CI]

DoR，月，中位数 [95% CI]

13.8 [7.4, NE]

13.8 [7.4, 东北]

13.8 [4.6, NE]

13.8 [4.6，东北]

15.7 [5.1, NE]

15.7 [5.1, 东北]

PFS, months, median [95% CI]

无进展生存期，月，中位数 [95% 置信区间]

10.2 [8.0, 15.4]

10.2 [8.0, 15.4]

11.8 [5.6, 16.8]

11.8 [5.6, 16.8]

9.5 [6.5, 16.6]

9.5 [6.5, 16.6]

Abstract details:

摘要详情：

Abstract:

摘要：

2522

2522

Abstract Title: Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial

摘要标题：拉库单抗治疗复发性和难治性塞扎里综合征患者：TELLOMAK 2期试验的长期随访结果

Session Type: Poster Session

会议类型：海报会议

Session Title: Developmental Therapeutics—Immunotherapy

会议标题：发展治疗学——免疫疗法

Session Date and Time: Monday June 2, 2025 – 1:30 – 4:30 PM CDT

会议日期和时间：2025年6月2日星期一 – 下午1:30 – 4:30（中部夏令时）

Abstract:

摘要：

2523

2523

Abstract Title: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: Long-term follow-up and translational data from the TELLOMAK phase 2 trial

摘要标题：Lacutamab 治疗复发和/或难治性蕈样霉菌病患者：TELLOMAK 二期试验的长期随访和转化数据

Session Type: Poster Session

会议类型：海报会议

Session Title: Developmental Therapeutics—Immunotherapy

会议标题：发展治疗学——免疫疗法

Session Date and Time: Monday June 2, 2025 – 1:30 – 4:30 PM CDT

会议日期和时间：2025年6月2日星期一 – 下午1:30 – 4:30（中部夏令时间）

About Lacutamab

关于Lacutamab

Lacutamab 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 lymphoma of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages..

Lacutamab 是一种首创的抗 KIR3DL2 人源化诱导细胞毒性的抗体，目前正在进行临床试验，用于治疗皮肤 T 细胞淋巴瘤 (CTCL) 和外周 T 细胞淋巴瘤 (PTCL)，这两种均为罕见病。T 淋巴细胞的罕见皮肤淋巴瘤在晚期阶段预后较差，且有效和安全的治疗选择很少。

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. KIR3DL2 is expressed in up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL).

KIR3DL2是KIR家族的一种抑制性受体，在所有CTCL亚型中约65%的患者表达该受体，而在某些侵袭性CTCL亚型中，特别是塞扎里综合征，高达90%的患者表达该受体。在蕈样霉菌病和外周T细胞淋巴瘤（PTCL）患者中，KIR3DL2在多达50%的患者中表达。

It has a restricted expression on normal tissues..

它在正常组织上表达受限。

Lacutamab has been granted European Medicines Agency (EMA) PRIME designation, and the US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and the United States for the treatment of CTCL.

Lacutamab 获得了欧洲药品管理局 (EMA) 的优先药物 (PRIME) 认证，美国食品药品监督管理局 (FDA) 也授予其快速通道资格，用于治疗至少接受过两种前期全身治疗的复发或难治性 Sézary 综合征患者。Lacutamab 在欧盟和美国获得了治疗 CTCL 的孤儿药资格。

Lacutamab has received Breakthrough Therapy Designation from the FDA..

Lacutamab 已获得 FDA 的突破性疗法认定。

About TELLOMAK

关于TELLMAK

TELLOMAK (

特洛马克 (

NCT03902184

NCT03902184

) is a global, open-label, multi-cohort Phase 2 clinical trial in patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:

）是一项在美国和欧洲进行的针对塞扎里综合征和蕈样霉菌病（MF）患者的全球性、开放标签、多队列的2期临床试验。具体来说：

Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.

队列1：正在评估拉库单抗作为单一药物在约60名已接受至少两种先前全身性治疗（包括莫加利珠单抗）的塞扎里综合征患者中的效果。这项研究的塞扎里综合征队列可能有助于拉库单抗在此适应症中的注册。

Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design.

队列2：在基线时通过Simon两阶段设计确定，lacutamab作为单一药物正在KIR3DL2表达的MF患者中进行评估。

Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design.

队列3：在基线时确定为不表达KIR3DL2的MF患者中，lacutamab作为单药治疗进行评估，采用Simon两阶段设计。

All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic..

所有患者：正在评估拉库单抗作为单一药物在表达和不表达KIR3DL2的MF患者中的疗效，以探索KIR3DL2表达水平与治疗结果之间的相关性，利用正在开发的作为伴随诊断的福尔马林固定石蜡包埋（FFPE）检测方法。

The trial is fully enrolled. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.

该试验已全部招募完毕。试验的主要终点是客观的整体缓解率。关键的次要终点包括无进展生存期、缓解持续时间、总生存期、生活质量、药代动力学和免疫原性以及不良事件。

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