Abstract 1043P
Background
In Italy, Pembro and Pembro-CHT are indicated in first-line for advanced NSCLC. Apart from PD-L1, no other factors for selecting Pembro or Pembro-CHT are known. Our aim is to evaluate the impact of different clinical factors on outcomes of Pembro vs. Pembro-CHT.
Methods
We retrospectively collected data from 91 Pembro and 55 Pembro-CHT Pts, selected solely on the basis of PD-L1 expression as per Italian prescribing indications. We compared objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). We evaluated subgroups based on gender, performance status (ECOG-PS), measurable tumor burden (TB), number of metastatic sites (N#MTS), use of corticosteroids (CTS) or proton pump inhibitors (PPI). Since Pts progressing on Pembro can receive platinum-based CHT, we focused on OS to evaluate the global benefit of Pembro-CHT in first-line.
Results
Median follow up (FUP) was 10.6 months for Pembro and 5.9 months for Pembro-CHT. Outcomes, including OS for subgroups of interest, are reported in the table. No significant difference in PFS or OS was observed between Pembro and Pembro-CHT, with the exception of female Pts (15 of 18 of whom are currently alive in Pembro-CHT group). 88 Pembro Pts and 51 Pembro-CHT Pts were evaluable for ORR and DCR, the latter being higher with Pembro-CHT. Notably, 12 Pts (13.6%) in Pembro group experienced early death (ED) before the first response assessment, whereas no ED occurred with Pembro-CHT. Table: 1043P
| Pembro | Pembro-CHT | p | |
| PFS (months) | 5.7 | 5.4 | 0.40 |
| OS (months) | 14.4 | 12.5 | 0.99 |
| Males | 13.9 | 10.5 | 0.16 |
| Females | 14.6 | Not reached | 0.04 |
| High TB (≥62 mm) | 10.1 | 12.4 | 0.87 |
| Low TB (<62 mm) | 23.5 | 10.5 | 0.30 |
| N#MTS 1-2 | 23.3 | Not reached | 0.70 |
| N#MTS ≥ 3 | 7.7 | 9.5 | 0.56 |
| PS ECOG 0-1 | 22.6 | 13.9 | 0.61 |
| PS ECOG 2 | 2.7 | 1.5 | 0.20 |
| No CTS or ≤ 10mg/die | 22.8 | 13.9 | 0.35 |
| CTS > 10mg/die | 2.9 | Not reached | 0.08 |
| No PPI | 22.6 | 12.4 | 0.26 |
| PPI | 8.9 | 13.9 | 0.33 |
| ORR | 27.3% | 25.5% | 0.84 |
| DCR | 61.4% | 82.4% | 0.01 |
Conclusions
Pembro and Pembro-CHT achieved similar OS among most sub-groups apart from female Pts. Pembro-CHT had better DCR and might be associated with fewer rapid progression and ED. Longer FUP and enrichment of Pembro-CHT group will provide more robust data.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Italian Ministry of Health.
Disclosure
C. Dellepiane: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Roche, MSD. G. Rossi: Financial Interests, Personal, Invited Speaker: Roche, Novartis, Amgen, Janssen. C. Genova: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Roche, MSD, Takeda, Sanofi, Thermofisher; Financial Interests, Institutional, Research Grant: Italian Ministry of Health. All other authors have declared no conflicts of interest.