Abstract 1327P
Background
There has been an only indirect comparison between pembrolizumab (ICI) and pembrolizumab plus chemotherapy in patients with non-small cell lung cancer (NSCLC) and high programmed death-ligand 1 (PD-L1) expression (tumor proportion score [TPS] ≥50%). We compared the efficacy and safety of these treatments.
Methods
We consecutively reviewed the efficacy and safety of the 1st line ICI-containing regimen between December 2017 and December 2019. We divided the patients into the ICI with chemotherapy group (the ICI-combo group) and the ICI monotherapy group (the ICI-mono group). Propensity score matching (PSM) was applied at a ratio of 1:1.
Results
Of 450 advanced NSCLC patients who underwent 1st line treatment, 130 with PD-L1 TPS ≥50% treated by an ICI-containing regimen. Forty-eight were classified as the ICI-mono group, 30 into the ICI-Combo group. The median follow-up months was 6.0 months (0.5-11.9) in the ICI-Combo group and 12.4 months (0.4-18.6) in the ICI-mono group. The backgrounds of patients, age and performance status (PS) were almost similar. An overall response rate (ORR) of the ICI-Combo group was relatively higher than that of the ICI-mono group (76.9% vs. 55.8%). The median progression-free survival (mPFS) in the ICI-Combo group was relatively longer in the ICI-mono group (10.5 months vs. 7.0 months; hazard ratio (HR), 0.44; 95% confidence interval (CI), 0.18 to 1.06). This trend was also observed under PSM, HR 0.40 (95% CI, 0.13 to 1.19). At the time of analysis, the median overall survival had not been reached. Frequency of all adverse events (AE) and immune-related serious adverse events (irAE) of Grade 3 or higher were similar in both groups. Table: 1327P
The characteristics, preliminary efficacy analysis, progression-free survival, and safety of two groups
| Characteristics | ICI-Combo (n = 30) | ICI-mono (n = 48) |
| Age, median (range), years | 63.0 (46-78) | 66.4 (59-87) |
| PS ≥2, n (%) | 4 (13.3) | 7 (14.6) |
| Response evaluation (Number of patients [%]) | ||
| Complete Response | 0 (0.0) | 2 (4.7) |
| Partial Response | 20 (76.9) | 22 (51.2) |
| Stable Disease | 5 (19.2) | 9 (20.9) |
| Progressive Disease | 1 (3.8) | 10 (23.3) |
| Not Evaluable | 4 | 5 |
| ORR (95% CI), % | 76.9 (56.4 to 91.0) | 55.8 (39.9 to 70.9) |
| mPFS (95% CI), months | 10.5 (9.2 to NR) | 7.6 (4.6 to 12.7) |
| AE ≥Grade3, n (%) | 17 (56.7) | 29 (60.4) |
| irAE ≥Grade3, n (%) | 3 (10.0) | 8 (16.7) |
Conclusions
Although overall survival result was immature, it was suggested that ICI-Combo might have better short-term outcomes than ICI-mono.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
H. Horinouchi: Honoraria (self), Research grant/Funding (institution): BMS; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self), Research grant/Funding (institution): Taiho; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): Genomic Health; Honoraria (self), Research grant/Funding (institution): Lilly; Honoraria (self), Research grant/Funding (institution): Ono. Y. Okuma: Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Chugai; Honoraria (self): Ono; Honoraria (self): Ily Lilly; Honoraria (self): Bristol-Myers Squibb. T. Yoshida: Research grant/Funding (institution): MSD; Research grant/Funding (institution): Ono Pharmaceutical; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Takeda; Speaker Bureau/Expert testimony: Chugai; Speaker Bureau/Expert testimony: Novartis; Research grant/Funding (institution): AbbVie. Y. Goto: Honoraria (self), Research grant/Funding (institution): Eli Lilly; Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Guardant Health; Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): Kyorin; Research grant/Funding (institution): Dai-ichi Sankyo; Honoraria (self): Illumina. N. Yamamoto: Advisory/Consultancy, Research grant/Funding (institution): Eisai; Advisory/Consultancy, Research grant/Funding (institution): Takeda; Advisory/Consultancy: Otsuka; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Advisory/Consultancy: Cimic; Advisory/Consultancy, Research grant/Funding (institution): Chugai; Speaker Bureau/Expert testimony, Research grant/Funding (institution): BMS; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Eli Lilly; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Ono; Speaker Bureau/Expert testimony: Chugai; Speaker Bureau/Expert testimony: Sysmex; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Taiho; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Kyowa-Hakko Kirin; Research grant/Funding (institution): Janssen Pharma; Research grant/Funding (institution): MSD; Research grant/Funding (institution): MERCK; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Sumitomo Dainippon. Y. Ohe: Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Honoraria (self), Research grant/Funding (institution): Taiho; Honoraria (self), Research grant/Funding (institution): Takeda; Honoraria (self), Research grant/Funding (institution): Nippon Kayaku; Honoraria (self), Research grant/Funding (institution): Kyorin; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Janssen; Honoraria (self): Pfizer; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Kyowa Hakko Kirin; Honoraria (self): Celtrion; Honoraria (self): Amgen. All other authors have declared no conflicts of interest.