Akademik Veri Yönetim Sistemi
ESMO Congress , Berlin, Almanya, 17 - 21 Ekim 2025, ss.1469-1470, (Özet Bildiri)
Background: IMforte (NCT05091567) is the first Phase III study to demonstrate
statistically significant and clinically meaningful improvements in IRF-PFS (stratified
HR, 0.54; 95% CI: 0.43, 0.67) and OS (stratified HR, 0.73; 95% CI: 0.57, 0.95) with 1L
maintenance tx with lurbi + atezo vs atezo in ES-SCLC. Randomised patients (pts) had
CR/PR (88%) or SD (11%) to induction tx. The combination was generally well
tolerated, with manageable safety.
Methods: Eligible pts with ES-SCLC without PD after 1L induction tx with atezo,
carboplatin, and etoposide were randomised 1:1 to maintenance tx q3w with lurbi
3.2 mg/m2 + atezo 1200 mg or atezo until PD or unacceptable toxicity. We assessed
the patterns of RECIST-defined PD per IRF and evaluated the association of maintenance
baseline (BL) tumour burden with IRF-PFS and OS in randomised pts.
Results: Of 660 pts enrolled to receive induction tx, 483 were randomised to lurbi +
atezo (n=242) and atezo (n=241) maintenance tx. RECIST-defined PD per IRF was
seen in 143 pts (59%) in the lurbi + atezo arm and 183 pts (76%) in the atezo arm. Of
pts with PD, patterns of PD in the lurbi + atezo and atezo arms, respectively, were
target lesions (29% and 46%), non-target lesions (24% and 33%) and new lesions
(69% and 68%). Among pts with IRF-assessed measurable disease at the time of
randomisation, the median BL sum of diameters (SOD) was 44 mm. Pts were grouped
based on BL tumour burden (i.e., measurable disease with SOD <median vs
≥median, and non-measurable disease only) and IRF-PFS and OS analysed (Table).
OS IRF-PFS | ||||
Lurbi + atezo | Atezo | Lurbi + atezo | Atezo | |
Non-measurable disease only, n | 67 | 59 | 67 | 59 |
Median, mo | 16.4 | 12.2 | 7.3 | 2.8 |
Unstratified HR (95% CI) | 0.75 (0.44, 1.28) | 0.56 (0.36, 0.86) | ||
Measurable disease with baseline SOD <median, n | 89 | 86 | 89 | 86 |
Median, mo | 13.2 | 13.6 | 5.5 | 2.4 |
Unstratified HR (95% CI) | 0.96 (0.62, 1.47) | 0.58 (0.41, 0.82) | ||
Measurable disease with baseline SOD ≥median, n | 86 | 96 | 86 | 96 |
Median, mo | 11.7 | 8.6 | 4.2 | 1.6 |
Unstratified | 0.59 (0.40, 0.86) | 0.52 (0.37, 0.72) | ||
Conclusions: Proportionately fewer IRF-defined PD events were observed in target/
non-target lesions in the lurbi + atezo vs atezo arms. The addition of lurbi led to
greater OS improvement in pts with higher tumour burden among those with
measurable disease and to OS improvement in pts without measurable disease,
while IRF-PFS improvement was similar regardless of tumour burden