Miles: Honoraria (self), Advisory/Consultancy: Roche/Genentech Honoraria (self), Advisory/Consultancy: Eisai Honoraria (self), Advisory/Consultancy: Genomic Health. Legal entity responsible for the studyĭ.W. Jennifer Kelly (Medi-Kelsey Ltd), funded by F. Potential reasons for the contrast with the benefit seen in IMpassion130 (atezo + nab-paclitaxel) need further exploration. Table: LBA15Ītezo + PAC did not improve PFS or OS vs placebo + PAC. Grade 5 (2% placebo vs 2% atezo) and grade 3/4 AEs (43% vs 49%) were balanced between arms and the safety profile was consistent with known risks of each study drug. PAC exposure was not compromised by the addition of atezo. PFS results in subgroups were consistent with primary results. Adding atezo to PAC did not improve PFS or OS in either the PD-L1+ or ITT populations (Table). Of 651 randomised patients, 45% had PD-L1+ mTNBC, 48% were taxane pretreated, 31% had de novo mTNBC and 27% liver metastases. OS and overall response rate (ORR) were secondary endpoints. The primary endpoint was investigator-assessed PFS, tested hierarchically first in the PD-L1+ (IC ≥1%) population, then in the intent-to-treat (ITT) population. Stratification factors were tumour PD-L1 status (immune cell expression <1% vs ≥1% by VENTANA SP142 assay), prior taxane, liver metastases and geographic region. MethodsĮligible patients (no prior systemic therapy or ≥12 months since adjuvant chemotherapy) were randomised 2:1 to atezo 840 mg or placebo (d 1 & 15 q28d), both with PAC 90 mg/m 2 (d 1, 8 & 15 q28d) until disease progression or unacceptable toxicity. IMpassion131 (NCT03125902) evaluated atezo + PAC as first-line treatment for mTNBC. In the phase 3 IMpassion130 trial, combining atezo with first-line nab-paclitaxel for mTNBC showed significantly improved progression-free survival (PFS) and clinically meaningful overall survival (OS) benefit in patients with PD-L1+ mTNBC.
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