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A Phase 3 Study (TILVANCE-301) to Assess the Efficacy and Safety of Lifileucel, an Autologous Tumor-Infiltrating Lymphocyte Cell Therapy, in Combination with Pembrolizumab Compared with Pembrolizumab Alone in Patients with Untreated Unresectable or Metastatic Melanoma.

JOURNAL OF CLINICAL ONCOLOGY(2023)

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Abstract
TPS9607 Background: Most patients (pts) with advanced (unresectable or metastatic) melanoma receiving front-line immune checkpoint inhibitor (ICI) therapy progress within a year (Robert Lancet Oncol 2019; Larkin NEJM 2019; Tawbi NEJM 2022). Early-line therapies are needed to improve the rate of deep and durable responses and increase the proportion of pts with long-term benefit. Lifileucel demonstrated an ORR of 31.4% and median DOR not reached (median 36.5 mo follow-up) in pts with post-ICI advanced melanoma (Sarnaik SITC 2022). Earlier-line treatment with lifileucel plus pembrolizumab (pembro) in pts with ICI-naïve advanced melanoma demonstrated an ORR of 67%, including a CR rate of 25% (Iovance Press Release, April 5, 2022; O’Malley JITC 2021). TILVANCE-301 will evaluate the efficacy and safety of lifileucel plus pembro compared with pembro alone in pts with untreated advanced melanoma. Methods: TILVANCE-301 (NCT05727904) is a phase 3, multicenter, randomized, open-label, parallel group, treatment study that will randomize ~670 pts (1:1) to either Arm A: lifileucel plus pembro (study intervention includes tumor tissue resection, pembro, nonmyeloablative lymphodepletion [NMA-LD], lifileucel infusion, an abbreviated course of high-dose IL-2, and thereafter, continued pembro) or Arm B: pembro alone. Pts in Arm B who receive pembro and experience confirmed progressive disease verified by blinded independent review committee (BIRC) have the option to receive lifileucel as the immediate next line of treatment. Eligible adults have histologically confirmed advanced melanoma (Stage IIIC, IIID, or IV); ECOG PS of 0 or 1; estimated life expectancy > 6 mo; ≥1 resectable lesion ~1.5 cm in diameter postresection to generate lifileucel and ≥1 measurable lesion (RECIST v1.1); and adequate hematologic parameters and organ function. Neoadjuvant or adjuvant treatment including ICI meeting protocol-specified criteria may be allowed. Exclusion criteria include prior therapy for metastatic disease; symptomatic untreated brain metastases; organ allograft or prior cell transfer therapy; uveal/ocular melanoma; chronic systemic steroid therapy; active systemic infections; cardiovascular, respiratory, or immune system illnesses; primary/acquired immunodeficiency; or other primary malignancy in the last 3 y. The dual primary efficacy endpoints are BIRC-assessed (RECIST v1.1) ORR and PFS. Key secondary efficacy endpoint is OS. Additional secondary efficacy endpoints include BIRC-assessed CR rate, DOR, and EFS; investigator-assessed ORR, PFS, CR rate, DOR, EFS, and PFS2; and safety as characterized by severity and seriousness of TEAEs, and relationship to study drug. The study will enroll globally. Clinical trial information: NCT05727904 .
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Intratumor Heterogeneity,Tumor Regression,T Cell Therapy
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要点】:本研究是一项III期临床试验(TILVANCE-301),旨在评估自体肿瘤浸润淋巴细胞疗法(lifileucel)与派姆单抗(pembro)联合治疗对比单独使用派姆单抗在未治疗的高级黑色素瘤患者中的疗效和安全性。

方法】:研究采用多中心、随机、开放标签、平行组设计,将约670名患者以1:1的比例随机分配到A组(lifileucel加pembro)或B组(单独pembro)。A组的治疗包括肿瘤组织切除、pembro、非骨髓消融性淋巴耗竭(NMA-LD)、lifileucel输注、简短的高剂量IL-2治疗,之后继续使用pembro。

实验】:实验将评估盲标独立审查委员会(BIRC)根据RECIST v1.1标准评估的客观缓解率(ORR)和无进展生存期(PFS)作为双重主要疗效终点。次要疗效终点包括总生存期(OS)、BIRC评估的完全缓解率(CR)、缓解持续时间(DOR)、无事件生存期(EFS)等。研究将全球范围内招募患者。数据集名称未提及,但实验结果将基于NCT05727904临床试验的数据。