Rutger’s Cancer Institute of New Jersey, New Brunswick, NJ
Peter D. Cole , Christine Mauz-Körholz , Maurizio Mascarin , Gérard Michel , Stacy Cooper , Auke Beishuizen , Kasey J. Leger , Loredana Amoroso , Salvatore Buffardi , Charlotte Rigaud , Markus Puhlmann , Stephen Francis , Mariana Sacchi , Richard A. Drachtman , Paul David Harker-Murray , Thierry Leblanc , Stephen Daw , Kara M. Kelly
Background: Outcomes for younger patients (pts) with R/R cHL are poor, particularly for those without complete metabolic response (CMR) before autologous transplant (auto-HCT). Nivolumab + BV has shown 67% CMR and a high 2-y PFS rate as first salvage in adults with R/R cHL. CheckMate 744 (NCT02927769) is an ongoing phase 2 study for CAYA with R/R cHL, evaluating a risk-stratified, response-adapted approach using nivolumab + BV and, for pts without CMR, BV + bendamustine. In the initial analysis of the standard-risk cohort (R2), the regimen was well tolerated with high CMR rates before consolidation with high-dose chemotherapy plus auto-HCT. We report data from the primary analysis. Methods: Pts were aged 5–30 y and had first-line treatment (tx) without auto-HCT. Risk stratification has been described previously (Harker-Murray, ASH 2018). Pts received 4 induction cycles of nivolumab + BV; pts without CMR by blinded independent central review (BICR) received BV + bendamustine intensification. Pts with CMR at any time could proceed to consolidation off study. Response was per Lugano 2014 criteria. Primary endpoint: CMR rate (Deauville ≤3) per BICR any time before consolidation. Results: At database lock, 44 pts were treated in R2 (median follow up: 20.9 mo); 43 received 4 induction cycles and 11 received intensification. Median age was 16 y (range 9–30); 24 (55%) pts had primary refractory cHL and 20 had relapsed cHL. CMR rates and ORR any time before consolidation and after induction are shown in Table. 1-y PFS rate by BICR was 91% (90% CI 77–96). During induction, 8 (18%) pts experienced grade (G) 3–4 tx-related adverse events (TRAEs); the most common any grade TRAEs were nausea and hypersensitivity (20% each). 1 TRAE led to discontinuation (G3 anaphylaxis). Most tx-related immune-mediated AEs were G1–2 (1 pt had 2 G3 infusion-related reactions). Conclusions: This risk-stratified, response-adapted approach offers a well-tolerated salvage strategy with high CMR rates and no new safety signals for CAYA with R/R cHL. Most pts avoided alkylator exposure prior to consolidation. Further follow up may confirm durability of disease control. Clinical trial information: NCT02927769.
BICR | INV | |
---|---|---|
Any time before consolidation | ||
n | 43 | 44 |
CMR, n (% [90% CI]) | 38 (88 [77–95]) | 39 (89 [78–95]) |
ORR, n (%) | 42 (98) | 43 (98) |
After 4 cycles nivolumab + BV induction | ||
n | 44 | 44 |
CMR, n (%) | 26 (59) | 29 (66) |
ORR, n (% [90% CI]) | 36 (82 [70–91]) | 39 (89 [78–95]) |
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Abstract Disclosures
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