KEY TAKEAWAYS
- The LUMINANCE phase III trial aimed to evaluate durvalumab combined with extended chemo in real-world SCLC patients for improved efficacy, including those with poorer performance status.
- Primary endpoints were rates of grade ≥3 AEs and imAEs. Secondary endpoints included ORR, DoR, PFS, and OS.
- The study confirmed D + EP as the first-line for advanced lung cancer, with safety and efficacy comparable to CASPIAN, even in patients receiving extended chemo-immunotherapy.
The CASPIAN study (NCT03043872) established durvalumab (D) in combination with etoposide and platinum (EP) as a global standard of care(SoC) for first-line treatment in extensive-stage small cell lung cancer (ES-SCLC) patients with WHO performance status (PS) 0–1. Typical of phase 3 registration studies, certain design aspects didn’t fully mirror real-world clinical practice.
For this study, researchers aimed to evaluate D combined with extended chemo (up to 6 cycles) in real-world SCLC patients for improved efficacy, including those with poorer performance status.
Treatment-naïve extensive-stage small cell lung cancer (ES-SCLC) patients with WHO performance status (PS) 0–2 were administered D at 1500 mg in combination with EP every 3 weeks for up to 6 cycles (determined by the investigator), followed by durvalumab every 4 weeks until disease progression.
Primary endpoints included the rates of grade ≥3 adverse events (AEs) and immune-mediated AEs (imAEs), while secondary endpoints comprised objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
About 152 patients from 32 sites across 5 countries were treated, with a median follow-up of 37.3 weeks, and 23.7% still received D. The median age was 64.0 years; 64.5% were male, and 99.3% were white. Patients received a median of 8.5 durvalumab doses; 63.8% received carboplatin, and 38.8% received cisplatin.
Grade ≥3 adverse events(AEs) occurred in 59.2% of patients; notable ones included neutropenia (26.3%), anemia (9.9%), and decreased neutrophil count (7.9%). Among those who received 1–4 or ≥5 cycles of EP*, grade ≥3 AEs occurred in 66.7% and 52.9%, respectively. Immune-mediated AEs occurred in 13.8% of patients, with hypothyroidism being the most common (6.6%).
The confirmed objective response rate was 65.8% (57.7–73.3), median progression-free survival was 6.2 months ( 5.3–6.5), and median overall survival(95% CI was 13.1 months (10.1–NE). Numerically improved outcomes were observed in patients who received ≥5 cycles of EP.
The study confirmed D + EP as the first-line for advanced lung cancer, with safety and efficacy comparable to CASPIAN, even in patients receiving extended chemo-immunotherapy.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/23
Clinical Trials: https://clinicaltrials.gov/study/NCT04774380
https://clinicaltrials.gov/study/NCT03043872
Reinmuth N. Primary results from the Phase 3b LUMINANCE study: First-line durvalumab plus platinum-etoposide for patients with extensive-stage small cell lung cancer (ES-SCLC). Presented at ESMO IO 2023. Abstract Session: LBA2.
