Abstract 1531P
Background
IMpower133 Phase III study showed that the addition of ATZ to CB+ET in 1L ES-SCLC statistically and clinically improved overall survival (OS) and progression-free survival (PFS) compared to CB+ET alone. IMfirst evaluates the safety of ATZ+CB/CP+ET in an interventional RW clinical setting of ES-SCLC. An induction safety analysis was previously reported and here we present primary safety and efficacy results.
Methods
In contrast to IMpower133, eligible patients (pts) also included those with ECOG Performance status (PS) 2, asymptomatic untreated central nervous system (CNS) metastases, stable autoimmune diseases and HIV+. Consolidation radiotherapy (CRt) and up to 6 chemotherapy (C) cycles were allowed.
Results
155 pts were enrolled; 47% were ≥65 years old, 72% were male, 89% had ECOG PS 0-1 and 99% had smoking history. 17% of pts had baseline CNS metastases, 10% received prophylactic cranial irradiation, and 8% received CRt. 41% of pts received 5-6 cycles of C and 88% of pts received CB as induction C. 61% of pts met IMpower133 trial-like eligibility criteria. The median (m) number of cycles of ATZ received was 9 (range 1-35) and 86% of pts reached the maintenance phase. Grade (gr) 3-4 treatment-related (TR), serious (S) and immune-mediated (IM) adverse events (AEs) were 43 (27.8%), 15 (9.7%) and 3 (1.9%) respectively. One Gr 5 TRSAE (subileus) was reported. TRAEs led to discontinuation of ATZ, CB/CP or ET in 5.8%, 2.6% and 2.6% of pts, respectively. Median follow-up was 18.8 months (data cut-off: 19 January 2022). mOS was 10 mo (95% CI: 8.60, 11.93); OS at 12 and 18 mo was 42% and 25%. mOS for ECOG 0-1 pts was 10.9 mo and 9.3 mo for ECOG 2 pts, although differences were not statistically significant. mPFS was 6.2 mo (95% CI: 5.82, 6.41); PFS at 6 and 12 mo was 55% and 14%. Among pts treated beyond progression (19%), the m number of additional cycles of ATZ was 3 (range 1-18) and the mOS was 13.2 mo (95% CI: 8.0, NE).
Conclusions
The primary results of IMfirst confirm the safety profile of ATZ+C. Efficacy data was in line with previous reports and may help inform treatment decisions for pts generally excluded from pivotal trials.
Clinical trial identification
EudraCT 2019-002784-10.
Editorial acknowledgement
Medical writing assistance for this abstract was provided by Antoni Torres, PhD, of MSC consulting.
Legal entity responsible for the study
Roche Farma S.A.
Funding
Roche Farma S.A.
Disclosure
M.R. Garcia Campelo: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, PharmaMar, Bayer, AbbVie, GSK, Boehringer; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, PharmaMar, Bayer, AbbVie, GSK, Boehringer; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Boehringer. M. Domine Gomez: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Pfizer, AbbVie, Boehringer; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, Pfizer, Boehringer; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, BMS, AstraZeneca, Lilly, Pfizer, Boehringer. J. De Castro Carpeno: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Pfizer, PharmaMar, Boehringer, Takeda, Tesaro; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, AstraZeneca, Boehringer, Takeda; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Merck, BMS, AstraZeneca. A.L. Moreno Vega: Financial Interests, Other, Honoraria: Roche Farma S.A, AstraZeneca, PharmaMar; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Pfizer. S. Ponce Aix: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, Pfizer, PharmaMar, Bayer, Amgen, Boehringer, Takeda, Lilly. E. Arriola: Financial Interests, Other, Honoraria: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Boehringer, Takeda; Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Boehringer, Takeda; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Boehringer, Takeda; Financial Interests, Research Grant: Roche Farma S.A, BMS, Pfizer, Boehringer; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Boehringer. E. Carcereny Costa: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, Pfizer, Boehringer, Takeda; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, GSK, Takeda; Financial Interests, Other, Travel and accommodation: Roche Farma S.A. M. Majem Tarruella: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Amgen, Boehringer, Takeda; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, Bayer, Amgen, Boehringer; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Merck, Lilly. E. Esteban Gonzalez: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, AstraZeneca, Pfizer, Janssen, Ipsen, Boehringer, Takeda; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Bayer, Janssen, Ipsen, Takeda; Financial Interests, Research Grant: Roche Farma S.A, Merck, BMS, AstraZeneca, Lilly, Pfizer, Bayer, Janssen, Ipsen, Takeda. J. Fuentes Pradera: Financial Interests, Advisory Board: Roche Farma S.A, BMS, Pfizer, GSK. A.L.O. Ortega Granados: Financial Interests, Advisory Board: Roche Farma S.A, Merck, BMS, Boehringer; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, Boehringer; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Merck, BMS; Financial Interests, Other: AstraZeneca, Lilly, Pfizer, PharmaMar, Bayer, AbbVie, Amgen, Janssen, GSK, Ipsen, Takeda, Sanofi, Tesaro. M. Guillot Morales: Financial Interests, Other, Travel and accommodation: Roche Farma S.A, Merck, Sanofi; Financial Interests, Other: BMS, AstraZeneca, Lilly, Pfizer, PharmaMar, Bayer, AbbVie, Amgen, Janssen, GSK, Ipsen, Boehringer, Takeda, Tesaro. B. Massuti Sureda: Financial Interests, Advisory Board: Roche Farma S.A, Merck, AstraZeneca, Boehringer, Takeda; Financial Interests, Invited Speaker: Roche Farma S.A, Merck, BMS, Pfizer, Boehringer. L. Vila Martinez: Financial Interests, Other, Honoraria: Roche Farma S.A, Merck, BMS, AstraZeneca, Pfizer, Sanofi; Financial Interests, Advisory Board: Roche Farma S.A, AstraZeneca, Boehringer; Financial Interests, Other, Travel and accommodation: BMS, Lilly, Pfizer. A. Blasco Cordellat: Financial Interests, Invited Speaker: Roche Farma S.A, BMS, AstraZeneca, Pfizer, Takeda; Financial Interests, Research Grant: Roche Farma S.A, BMS, AstraZeneca, Pfizer, Bayer, Amgen, Janssen; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, BMS, Pfizer, Janssen; Financial Interests, Advisory Board: BMS, AstraZeneca, Amgen, Takeda. C.A. Fajardo: Financial Interests, Personal, Full or part-time Employment: Roche Farma S.A. L. Crama: Financial Interests, Full or part-time Employment: Roche Farma S.A. N. Lerones Laborda: Financial Interests, Full or part-time Employment: Roche Farma S.A. M. Cobo Dols: Financial Interests, Advisory Board: Roche Farma S.A, BMS, Pfizer, Boehringer; Financial Interests, Other, Travel and accommodation: Roche Farma S.A, BMS; Financial Interests, Other: Merck, Lilly, PharmaMar, Bayer, Abbie, Amgen, Janssen, GSK, Ipsen, Takeda, Sanofi, Tesaro. All other authors have declared no conflicts of interest.