BEMPEG Plus Nivolumab Shows First-Line Potential In Metastatic Melanoma

Author: By Lynda Williams, Senior medwireNews Reporter 

medwireNews: The addition of bempegaldesleukin (BEMPEG) to first-line nivolumab therapy is well tolerated and warrants further study in patients with metastatic melanoma, preliminary research suggests. 

The combination of the CD122-preferential interleukin-2 pathway agonist and the PD-1 inhibitor was investigated in a phase II trial of 41 patients with treatment-naïve stage III or IV melanoma.  

The participants were treated at 3-week intervals with BEMPEG 0.006 mg/kg plus nivolumab 360 mg for up to 2 years, the investigators write in the Journal of Clinical Oncology. 

The co-primary safety endpoint of treatment-related adverse events (TRAEs) was reported in 95.1% of patients, but just 17.1% experienced grade 3 or 4 events. These included two (4.9%) cases each of atrial fibrillation and acute kidney injury, and single (2.4%) cases of dizziness, dyspnoea, hypoxia, hyperglycaemia and hypernatremia. TRAEs led to discontinuation of treatment in 12.2% of patients. 

Adi Diab, from the University of Texas MD Anderson Cancer Center in Houston, USA, and co-workers say that the co-primary endpoint of objective response after a median 29.0 months of follow-up was 52.6% for the 38 patients assessed, with a complete response recorded in 34.2%. 

There was a median 78.5% reduction in target lesions from baseline, including complete clearance of lesions in 47.4%.  

Median progression-free survival (PFS) was 30.9 months; median overall survival has not been reached but 82.3% and 77.0% of the patients were alive after 1 and 2 years, respectively. 

“Although comparisons cannot be formally made across trials, our preliminary findings indicate that BEMPEG plus [nivolumab] has the potential to provide additional efficacy over PD-1 inhibition alone”, say the investigators, citing the CheckMate 067 trial’s objective response rate for nivolumab monotherapy of 44%, a median tumour reduction in tumour burden of 35% and a median PFS of 6.9 months.

“These data demonstrate encouraging safety and efficacy for this novel immunotherapy combination of BEMPEG plus [nivolumab] in first-line metastatic melanoma”, conclude Adi Diab and co-authors.

“They provide rationale for the ongoing phase III study in this same patient population (PIVOT IO 001; NCT03635983).” 

Reference 

Diab A, Tykodi SS, Daniels GA, et al. Bempegaldesleukin plus nivolumab in first-line metastatic melanoma. J Clin Oncol; Advance online publication 13 July 2021. DOI: 10.1200/JCO.21.00675