PE-PE is a fantastic study, giving us randomized data on adding pembrolizumab to MDT in oligometastatic RCC!
Phase II, open-label, multicenter trial: 85 pts with prior nephrectomy and ≤3 mets within 5y of nephrectomy or previous metastasectomy, all amenable to surgery or SABR. Randomized 2:1 favoring pembro: MDT alone (n=29) vs pembro + MDT (n=56).
Pembro 400 mg q6w x9c (1y). First dose BEFORE MDT; registry specifies MDT on C1d21-42.
At MFU 17.5 mo, median RFS was 11→ 25.4 mo (HR 0.47, 95CI 0.24-0.92, p=0.024), MDT alone→ pembro + MDT. 35 RFS events, 16→ 19.
SABR 72→ 73%; surgery 28→ 23%. SABR dose/fx and per-site data weren't reported. I'd like to see those details along with local vs distant relapse.
Any AE 21→ 80%; G3 AEs 3→ 7%. The 21% control rate is with no study systemic therapy. Pembro-related AEs occurred in 59%, including G3 in 2 pts; no G4/5 pembro-related events were reported. Four pts stopped pembro for AEs.
Both groups received MDT, so the randomized question is what pembro adds. This doesn't establish the benefit of MDT itself or RT-ICI synergy. With 1 death/arm and no QoL results reported, an OS/QoL benefit remains unestablished.
I'd also like the prior systemic therapy history and the timing/burden at first metastatic presentation. The eligibility window alone doesn't tell us whether these pts were oligometastatic from the outset.
Congratulations to the investigators on this important work!
cslide.ctimeetingtech.com/es…
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