Dr. Brugarolas on unmet needs in the renal cell carcinoma treatment paradigm

"While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations," says Michael P. Bailey.

“These findings provide a plausible mechanism for the enhanced clinical outcome with CBM588 now seen across 2 small, randomized trials,” write the authors.

This announcement comes on the heels of an FDA acceptance of an investigational new drug application for ADI-270 in June.

CBM588 could be exciting in cancer treatment because of its potential to enhance the efficacy of immune checkpoint inhibitor-based treatment, improve patient outcomes, and modulate the gut microbiota in beneficial ways,” says Sumanta Pal, MD.

"The addition of efficacy data from the KEYNOTE-B61 trial reinforces the important role of KEYTRUDA plus LENVIMA as a frontline treatment option for adult patients with advanced RCC regardless of histology," says Takashi Owa, PhD.

A phase 1 trial of ADI-270 in clear cell RCC is expected to launch in the second half of 2024.