When Relatlimab, a LAG3-inhibitor was combined with nivolumab, progression free survival was significantly improved when compared with nivolumab alone: N Engl J Med 2022; 386:24-34
The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting. Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)-blocking antibody, and if BRAF V600-positive, a BRAF inhibitor with or without an MEK inhibitor. The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%) Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.
On December 3, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection. Efficacy was evaluated in KEYNOTE-716 (NCT03553836), a multicenter, randomized (1:1), double-blind, placebo-controlled trial in patients with completely resected stage IIB or IIC melanoma.
FDA approved Tebentafusp for metastatic uveal melanoma. A randomized study showed Tebentafusp improved 1-yr survival to 73% compared with pembrilozumab or nivolumab (59%). www.nejm.org/doi/10.1056/NEJMoa2103485?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
www.nejm.org/doi/10.1056/NEJMoa2109970 Relatlimab (lymphocyte activation gene 3 inhibitor) and nivolumab combination doubled disease free survival rate when compared with nivolumab alone. However, overall survival data are not mature yet
In March 2022, FDA approved nivolumab and relatlimab combo as treatment of metastatic or unresectable melanoma. The efficacy is similar to nivolumab + ipilomumab combo, but adverse effects are less than ipilomumab.
When Relatlimab, a LAG3-inhibitor was combined with nivolumab, progression free survival was significantly improved when compared with nivolumab alone:
N Engl J Med 2022; 386:24-34
FDA approved this combination of Relatlimab and nivolumab in March 2022 (Opdualag)
The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.
Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)-blocking antibody, and if BRAF V600-positive, a BRAF inhibitor with or without an MEK inhibitor.
The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)
Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.
On December 3, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection.
Efficacy was evaluated in KEYNOTE-716 (NCT03553836), a multicenter, randomized (1:1), double-blind, placebo-controlled trial in patients with completely resected stage IIB or IIC melanoma.
FDA approved Tebentafusp for metastatic uveal melanoma. A randomized study showed Tebentafusp improved 1-yr survival to 73% compared with pembrilozumab or nivolumab (59%).
www.nejm.org/doi/10.1056/NEJMoa2103485?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
www.nejm.org/doi/10.1056/NEJMoa2109970
Relatlimab (lymphocyte activation gene 3 inhibitor) and nivolumab combination doubled disease free survival rate when compared with nivolumab alone.
However, overall survival data are not mature yet
In March 2022, FDA approved nivolumab and relatlimab combo as treatment of metastatic or unresectable melanoma.
The efficacy is similar to nivolumab + ipilomumab combo, but adverse effects are less than ipilomumab.