Abstract 170P
Background
The phase III CASPIAN study (NCT03043872) established D + EP as standard of care for 1L treatment (tx) of ES-SCLC; however, like most phase III registrational studies, the study population did not fully represent that found in real-world practice. The phase IIIb LUMINANCE study (NCT04774380) is evaluating D + up to 6 cycles of EP in pts with ES-SCLC, including those with WHO performance status (PS) 2. We report preliminary safety and efficacy results.
Methods
Pts from Europe and Turkey with tx-naïve ES-SCLC and WHO PS ≤2 received D 1500 mg + EP Q3W for 4–6 cycles (investigator's choice), followed by D Q4W until disease progression. Primary endpoints were the incidence of grade >3 AEs and of immune-mediated AEs (imAEs); secondary endpoints included ORR, PFS and OS.
Results
At the data cutoff (19 Aug 2022), median follow-up was 20.6 weeks; 51 pts had received tx and 70.6% of those were still receiving D. Median no. of D doses during the D + EP period was 5.0 (range 1–6); 47.1% of pts received 6 cycles of EP (table). Median age was 64.0 yrs, 58.8% of pts were male and 100% were white; 43.1%, 52.9% and 3.9% had WHO PS 0, 1 and 2, respectively. Grade >3 AEs occurred in 64.7% of pts (table); most common were neutropenia (37.3%), neutrophil count decreased (15.7%) and anaemia (9.8%). Grade >3 AEs occurred in 17/20 (85.0%) and 14/29 (48.3%) pts who received ≤4 or >4 cycles of EP, respectively (no. of EP cycles missing in 2 pts). imAEs occurred in 13.7% of pts; most common was hypothyroidism (5.9%). AEs leading to death occurred in 3 pts: 2 possibly related to EP and none to D. Confirmed ORR was 58.8% (table). PFS and OS will be assessed after longer follow-up.
Table: 170P| Total(N = 51) | |
|---|---|
| MEDIAN (RANGE) DOSES OF D DURING D + EP PERIOD | 5.0 (1–6) |
| EP CYCLES* | |
| Median (range) | 5.0 (1–6) |
| >4, n (%) | 43 (84.3) |
| >5, n (%) | 29 (56.9) |
| 6, n (%) | 24 (47.1) |
| ANY-CAUSE AE, n (%) | 48 (94.1) |
| Grade >3 | 33 (64.7) |
| Serious | 14 (27.5) |
| Immune-mediated | 7 (13.7) |
| Leading to death† | 3 (5.9) |
| CONFIRMED ORR, n (%) | 30 (58.8) |
| 95% CI | (44.2–72.4) |
| BEST OBJECTIVE RESPONSE, n (%) | |
| Partial response | 30 (58.8) |
| Stable disease for >6 wks | 13 (25.5) |
| Progressive disease | 4 (7.8) |
| Not evaluable | 4 (7.8) |
Based on etoposide exposure.
†Causes of death: acute kidney injury, pneumonia/cerebrovascular accident, pneumonia/sepsis.
Conclusions
Preliminary safety and efficacy findings from LUMINANCE, including pts receiving >4 cycles of induction chemo-IO, were consistent with those observed in CASPIAN. The most common grade >3 AEs were those typically associated with chemotherapy. The results further support the use of D+EP as 1L tx for pts with ES-SCLC.
Clinical trial identification
NCT04774380.
Editorial acknowledgement
Medical writing support for the development of the abstract, under the direction of the authors, was provided by Connor Keating of Ashfield MedComms (Manchester, UK) an Inizio company, and funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca PLC.
Funding
AstraZeneca.
Disclosure
N. Reinmuth: Financial Interests, Personal, Other, Honoraria: Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Eli Lilly, MSD, Merck, Pfizer, Symphogen, Takeda; Financial Interests, Personal, Other, Consulting: AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche, MSD, Merck, Pfizer.
F. de Marinis: Financial Interests, Personal, Other, Honoraria: AstraZeneca, BMS, Roche, Novartis, Janssen. S. Sadow: Financial Interests, Personal, Stocks/Shares: AstraZeneca; Financial Interests, Personal, Full or part-time Employment: AstraZeneca. K. Davey: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. M. Özgüroğlu: Financial Interests, Personal, Other, LUMINANCE Steering Committee Member: AstraZeneca. All other authors have declared no conflicts of interest.