Abstract 60MO
Background
This study evaluated the real-world outcomes among patients (pts) with squamous (SQ) or non-squamous cell (NSQ) advanced non-small cell lung cancer (aNSCLC) receiving either first-line (1L) immuno-oncology (IO) monotherapy or IO in combination with chemotherapy (IO+CT).
Methods
Eligible pts (age ≥18 years) were identified from the Flatiron Health database (January 2011 - March 2022) with confirmed aNSCLC (Stage III−IV) who received either 1L IO monotherapy or IO+CT on or after January 1, 2016. Pts with EGFR/ALK tumor mutations and pts with unknown histology were excluded. Overall survival (OS) and real-world progression-free survival (rwPFS) were estimated using Kaplan-Meier methods for the IO monotherapy and IO+CT cohorts. Analyses were also conducted by histology and tumor programmed death ligand 1 (PD-L1) subgroups.
Results
A total of 11,445 pts were identified, among which 4,354 (38%) received IO monotherapy and 7,091 (62%) received IO+CT. Among pts receiving IO monotherapy, median OS was 14.2 and 11.1 months for NSQ and SQ aNSCLC, respectively. Among pts receiving IO+CT, median OS was 12.1 months (NSQ) and 10.5 months (SQ). Median rwPFS was 4.7 months for pts receiving IO monotherapy, and was 5.6 months for pts receiving IO+CT. The table reports the OS and rwPFS results by histology and PD-L1 subgroups. Median OS and rwPFS were lowest in the tumor PD-L1 <1% subgroup among pts treated with IO+CT regardless of histology as well as among SQ pts receiving IO monotherapy. Table: 60MO
Survival outcomes for patients with SQ and NSQ aNSCLC receiving IO or IO+CT
IO | IO+CT | |||||
NSQ + SQ (N=4,354) | NSQ (N=3,094) | SQ (N=1,260) | NSQ + SQ (N=7,091) | NSQ (N=5,518) | SQ (N=1,573) | |
Median follow-up (months) | 8.3 | 8.5 | 8.1 | 7.7 | 7.8 | 7.5 |
OS (median months and 36-month rate) | ||||||
Overall, regardless of PD-L1 | 13.126.6% | 14.229.8% | 11.118.7% | 11.722.1% | 12.123.4% | 10.517.3% |
PD-L1 <1% | 12.219.4% | 13.419.2% | 10.219.4% | 10.216.7% | 10.117.2% | 10.215.3% |
PD-L1 ≥1–49% | 11.017.8% | 11.020.3% | 11.114.4% | 12.421.6% | 13.223.7% | 10.312.6% |
PD-L1 50–100% | 14.429.3% | 15.732.3% | 11.620.7% | 16.930.9% | 17.931.8% | 14.626.6% |
Median rwPFS (months) | ||||||
Overall, regardless of PD-L1 | 4.7 | 4.8 | 4.3 | 5.6 | 5.5 | 6.0 |
PD-L1 <1% | 4.2 | 4.1 | 4.6 | 4.9 | 4.7 | 5.6 |
PD-L1 ≥1–49% | 3.5 | 3.4 | 3.6 | 5.8 | 5.7 | 6.1 |
PD-L1 50–100% | 5.3 | 5.4 | 4.9 | 7.5 | 7.8 | 6.5 |
Conclusions
The real-world survival estimates were generally lower than those reported in pivotal trials and it further affirms the unmet need among patients with aNSCLC, especially among those with low PD-L1 expression levels.
Legal entity responsible for the study
The authors.
Funding
Bristol Myers Squibb.
Disclosure
D.M. Waterhouse: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, AstraZeneca, Amgen, Janssen, EMD Serono, Merck; Financial Interests, Personal, Advisory Role: Jazz pharmaceuticals, Exelixis, Eisai, Pfizer, Mirati Therapeutics, Regeneron/Sanofi, Fresenius Kabi, Lilly, Sanofi, Astellas, Gilead. S. Ray: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. K.A. Betts: Financial Interests, Institutional, Other, Keith A. Betts is employee of Analysis Group Inc., which has received consultancy fees from BMS: Bristol Myers Squibb. Y. Yuan: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. L. Yin: Financial Interests, Institutional, Other, Lei Yin is employee of Analysis Group Inc., which has received consultancy fees from Bristol Myers Squibb: Bristol Myers Squibb. S. Gao: Financial Interests, Institutional, Other, Sophie Gao is employee of Analysis Group Inc., which has received consultancy fees from BMS: Bristol Myers Squibb. M. Sundar: Financial Interests, Institutional, Other, Manasvi Sundar is employee of Analysis Group Inc., which has received consultancy fees from Bristol Myers Squibb: Bristol Myers Squibb. D. Stenehjem: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Dracen Pharmaceuticals, Iterion Therapeutics, Molecular Templates, SonALAsense, Salarius Pharmaceuticals; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, AstraZeneca, Bayer, Novartis, Jazz Pharmaceuticals.
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