ESMO field direct hit KEYNOTE-B61 trial results announced: the efficacy and safety of the first-line treatment of non-transparent cell kidney cancer with pambolizumab combined with rumpatinib

At this annual meeting, the Phase II KEYNOTE-B61 study discussed the efficacy and safety of first-line pambolizumab + renvatinib in the treatment of patients with non-transparent cell kidney cancer (nccRCC), and the results were published in the oral report session of genitourinary tumors

Abstract number: 1448O

：Phase II KEYNOTE-B61 study of pembrolizumab (Pembro) + lenvatinib (Lenva) as first-line treatment for non-clear cell renal cell carcinoma (nccRCC)

Previous Phase III KEYNOTE-581 studies have shown that first-line pambolizumab + lenvatinib treatment regimen improves overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in patients with renal clear cell carcinoma (ccRCC) compared with sunitinib

Patients with measurable lesions defined by the RECIST V1.

Figure 1 Study design

Of the 147 patients treated, 87 (59.

Figure 2 Patient ORR and DCR analysis

The median DOR was not reached (range: 1.
4+-7.
2+ months), and at 6 months, the PFS rate was 72.
3% (95% CI 60.
7-81.
0) and the OS rate was 87.
8% (95% CI 78.
5-93.
2).

Figure 3 Patient median DOR analysis

Of all patients treated (N=147), 127 (86.
4%) had treatment-related adverse events (TRAEs) of any level, most commonly hypertension (n=71; 48.
3%), diarrhea (n=37; 25.
2%), and hypothyroidism (n=37; 25.
2%), and 51 (34.
7%) had grade 3-4 TRAEs, with no deaths from TRAEs
.

The results of this preliminary analysis show that the first-line pambolizumab + lenvatinib treatment regimen has good anti-tumor activity and safety
in nccRCC.

References:

Wang Mumu

Reviewed: LR

Execution: LR