135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522

In the phase III KEYNOTE-522 study (NCT03036488), neoadjuvant (neoadj) pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) chemo followed by adjuvant (adj) pembro pbo in patients (pts) with early-stage TNBC showed a statistically significant improvement pCR (ypT0/Tis ypN0) and EFS (dual primary endpoints). We present PRO endpoint results from KEYNOTE-522. Pts previously untreated, nonmetastatic, centrally confirmed (stage T1c N1-2 or T2-4 N0-2 per AJCC) were randomized 2:1 to neoadj 200 mg Q3W pbo, both given 4 cycles of paclitaxel carboplatin then doxorubicin epirubicin cyclophosphamide. After surgery, pts received adj for up 9 cycles. PROs measured EORTC QLQ-30 QLQ-BR23 prespecified secondary objectives, EQ-5D VAS exploratory objectives. assessed during treatment phases analyzed who at least 1 completed ≥1 assessment within phases. Between-group differences LS mean change baseline latest time point ≥60%/80% completion/compliance using longitudinal model (no alpha assigned). A threshold 10 points has been published as meaningful change. analyses QLQ-C30 included 1145 (pembro chemo; n = 762; chemo, 383) 847 (n 539; 308). Completion/compliance rates wk 21 24 ≥80% groups. There no between group (Table).Table: 135MOBetween-group difference Wk (Neoadj) (Adj) endpoints all TNBCPrespecified ScaleaBetween-Group Difference (Pembro Pbo) Mean (95% CI)NeoadjbAdjcQLQ-C30- GHS/QoL−1.04 (−3.46, 1.38)−0.41 (−2.60, 1.77)- Emotional functioning−0.69 (−3.13, 1.75)−0.60 (−2.99, 1.79)- Physical functioning−2.85 (−5.11, −0.60)−1.57 (−3.36, 0.21)QLQ-BR23−0.13 (−1.92, 1.65)0.29 (−2.05, 2.63)EQ-5D VAS−1.61 (−3.87, 0.64)−0.59 (−2.40, 1.23)aPRO score range: 0–100.bQLQ-C30 383); 759; 382); 384).cQLQ-C30 308); 538; 306); 540; 310). Open table new tab aPRO 0–100. bQLQ-C30 384). cQLQ-C30 Neoadj did not have negative impact on HRQoL control untreated TNBC, reinforcing clinical benefit seen this regimen.