Relatlimab
LAG3 monoclonal antibody Relatlimab approved!
FDA Approves New Immunotherapy Combo for Metastatic Melanoma
- LAG3 monoclonal antibody Relatlimab approved!
MEDSCAPE DISCLOSURES March 18, 2022
The FDA tonight approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older, according to the drug's manufacturer, Bristol-Myers Squibb.
Approval was based on the company's RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (HR, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation vs 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the US market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets lymphocyte-activation gene 3 (LAG-3), a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a January 6 editorial in the New England Journal of Medicine.
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FDA批准新的免疫疗法组合治疗转移性黑色素瘤
- LAG3单克隆抗体Relatlimab获得批准!
2022年3月20日， 医境公司新闻
FDA昨晚批准了百时美施贵宝的一种免疫检查点抑制剂组合 nivolumab/ relatlimab-rmbw（Opdualag瑞拉立单抗），用于治疗成人和12岁或以上儿童不可切除或转移性黑色素瘤。批准的依据是该公司的RELATIVITY-047试验，该试验发现在355名随机分配到组合疗法的患者中，中位无病生存期（PFS）为10.1个月，而在359名单独接受nivolumab的患者中，中位无病生存期为4.6个月（HR，0.75；P=0.0055）。
百时美施贵宝公司在一份新闻稿中指出，在联合治疗组中，18.9%的患者报告了3/4级药物相关的不良事件，而NIVO单抗组只有9.7%；联合治疗组中14.6%的患者发生了导致停药的药物相关不良事件，而接受单一疗法的患者只有6.7%。
Relatlimab是该公司进入美国市场的第三个免疫检查点抑制剂，加上PD-1抑制剂nivolumab和CTLA-4阻断剂ipilimumab。Relatlimab的目标是淋巴细胞激活基因3（LAG-3），这是一种在激活的CD4+T细胞上发现的细胞表面受体。 Nivolumab加ipilimumab目前是治疗转移性或无法手术的黑色素瘤的标准疗法。