KEY TAKEAWAYS
- A randomized phase II trial is investigating the effectiveness of nivolumab with or without ipilimumab or relatlimab before surgery in patients with operable stage IIIB-IV melanoma.
- 30 cases entered two neoadjuvant boluses of nivolumab (480 mg) and relatlimab (160 mg) every four weeks, followed by surgery and adjuvant combination remedy.
- The trial’s primary endpoint, pathologic complete response (pCR) rate, was 57.
- The radiographic response rate using Response Evaluation Criteria in Solid Excrescences 1.1 was also 57.
- No grade 3- 4 vulnerable-affiliated adverse events were observed during the neoadjuvant period. In addition, the 1- and 2-time rush-free survival rate was significantly advanced in cases with a pathologic response (100 and 92) than those without (88 and 55).
The combination of Relatlimab and Nivolumab immunotherapy has been shown to give bettered progression-free survival compared to Nivolumab monotherapy in cases with advanced, unresectable melanoma. Therefore, researchers conducted a study to probe this authority’s efficacity in cases with resectable clinical stage III or oligometastatic stage IV carcinoma (NCT02519322). Actors entered two neoadjuvant boluses (Nivolumab 480 mg and Relatlimab 160 mg intravenously every four weeks) followed by surgery and ten boluses of adjuvant combination remedy.
The primary endpoint was the pathologic complete response (pCR) rate2. Results showed that the combination of Relatlimab and Nivolumab achieved a pCR rate of 57 and an overall pathologic response rate of 70 among the 30 cases that passed treatment. The radiographic response rate was also 57 according to Response Evaluation Criteria in Solid Excrescences 1.1. No grade 3- 4 vulnerable-affiliated adverse events were observed in the neoadjuvant setting.
The 1- and 2-time rush-free survival rate was 100 and 92 for cases with a pathologic response, compared to 88 and 55 for those who didn’t admit a pathologic response (P = 0.005). Increased vulnerable cell infiltration at birth, and a drop in M2 macrophages during treatment, were associated with pathologic response. Our findings demonstrate that neoadjuvant Relatlimab and Nivolumab induce a high pCR rate with satisfactory safety compared to other combination immunotherapy rules. When coupled with the results of the Reciprocity- 047 trial1, these data further validate the efficacity and safety of this new immunotherapy authority.
Source:https://pubmed.ncbi.nlm.nih.gov/36289334/
Clinical trial:https://clinicaltrials.gov/ct2/show/NCT02519322
Amaria, R.N., Postow, M., Burton, E.M., Tezlaff, M.T., Ross, M.I., Torres-Cabala, C., Glitza, I.C., Duan, F., Milton, D.R., Busam, K., Simpson, L., McQuade, J.L., Wong, M.K., Gershenwald, J.E., Lee, J.E., Goepfert, R.P., Keung, E.Z., Fisher, S.B., Betof-Warner, A., Shoushtari, A.N., Callahan M, Coit D, Bartlett E, Bello D, Momtaz P, Nicholas C, Gu A, Zhang X, Korivi B, Patnana M, Patel S, Diab A, Lucci A, Prieto V, Davies M, Allison J, Sharma P, Wargo J, Ariyan C, Tawbi H. (2022). Neoadjuvant relatlimab and nivolumab in resectable melanoma. Nature, 611(7934), pp.155–160. doi:https://doi.org/10.1038/s41586-022-05368-8.
