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Primary results from IMpassion131, a double-blind placebo-controlled randomised phase III trial of first-line paclitaxel (PAC) ± atezolizumab (atezo) for unresectable locally advanced/metastatic triple-negative breast cancer (mTNBC)
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- impassion131 NCT03125902 esmo 2020
IMpassion131: Trial did not meet the primary end point of PFS and disappointed the oncology community
Abstract No : Abstract: #LBA15
Indication : Breast cancer
Intervention : Atezolizumab
Company : Roche
Technology : PD-1/PD-L1 inhibitor
Results:
Of 651 randomised patients, 45% had PD-L1+ mTNBC, 48% were taxane pretreated, 31% had de novo mTNBC and 27% liver metastases. Adding atezo to PAC did not improve PFS or OS in either the PD-L1+ or ITT populations (Table). PFS results in subgroups were consistent with primary results. PAC exposure was not compromised by the addition of atezo. 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.
Conclusion:
Atezo + PAC did not improve PFS or OS vs placebo + PAC. No new safety signals were seen. Potential reasons for the contrast with the benefit seen in IMpassion130 (atezo + nab-paclitaxel) need further exploration.
Executive Summary
Current standard of care (PD-L1 inh + Abraxane) remains unchallanged as Roche presents disappointing results from the failed trial. Unexpectantly no improvement seen in PFS or OS. Worse mortality though not significant reported. Benefit wasn't seen in any sub-group