Abstract 44P
Background
The randomized, double-blind phase II PERLA trial was the first global head-to-head comparison of 2 programmed death (PD)-1 inhibitors in NSCLC and showed similar efficacy for Dos + CT and Pem + CT with no new safety signals identified. Here, we report overall response rate (ORR) by pt and disease characteristics.
Methods
PERLA evaluated efficacy of Dos + CT and Pem + CT as first-line treatment for pts with metastatic non-squamous NSCLC, no targetable oncogenic drivers, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1. Pts, stratified by PD-L1 and smoking status, were randomized 1:1 to Dos 500 mg or Pem 200 mg every 3 weeks (Q3W) for ≤35 cycles, both combined with ≤35 cycles of 500 mg/m2 pemetrexed and ≤4 cycles of platinum-based chemotherapy (area under curve5 mg/mL/min carboplatin or 75 mg/m2 cisplatin) Q3W. Disease assessments were at Week (W) 6 and 12, then every 9Ws until W48, then every 12Ws. ORR by pt and disease characteristics were exploratory analyses; point estimates and 95% Clopper–Pearson confidence intervals (CIs) were assessed.
Results
ORR by pt and disease characteristic subgroups are shown in the table. ORR was similar across subgroups and numerically favoured Dos + CT in all but those with ECOG PS 0, in which it was 46% for both treatment groups. ORR remained the same within Dos + CT regardless of age or ECOG PS (46%); however, ORR was lower in patients treated with Pem + CT who had ECOG PS 1 as opposed to 0.
Table: 44PORR by pt/disease characteristics
| ORR,* % (95% CI), n/N | Dos + CT (N = 121) | Pem + CT (N = 122) |
|---|---|---|
| Age | - | - |
| <65 years | 46 (33.7–59.0), 30/65 | 35 (22.9–48.9), 20/57 |
| ≥65 years | 46 (33.0–60.3), 26/56 | 38 (26.7–51.4), 25/65 |
| Sex | - | - |
| Female | 42 (25.5–59.2), 15/36 | 33 (20.0–49.0), 15/45 |
| Male | 48 (37.3–59.3), 41/85 | 39 (28.0–50.8), 30/77 |
| ECOG PS | - | - |
| 0 | 46 (29.5–63.1), 17/37 | 46 (31.8–60.7), 23/50 |
| 1 | 46 (35.5–57.6), 39/84 | 31 (20.2–42.5), 22/72 |
| Brain metastasis | - | - |
| Yes | 50 (28.2–71.8), 11/22 | 27 (7.8–55.1), 4/15 |
| No | 45 (35.4–55.8), 45/99 | 38 (29.1–48.2), 41/107 |
| Platinum-based chemotherapy | - | - |
| Cisplatin | 41 (20.7–63.6), 9/22 | 36 (12.8–64.9), 5/14 |
| Carboplatin | 47 (37.3–57.8), 47/99 | 37 (27.9–46.9), 40/108 |
by blinded independent central review per RECIST v1.1.
Conclusions
ORR was similar between treatments and subgroups. In addition to the similar efficacy between treatments and tolerable safety profile, reported previously for PERLA, these results support further investigation of Dos in combination with other therapies.
Clinical trial identification
NCT04581824.
Editorial acknowledgement
Editorial support was provided by Eva Kane, PhD, of Fishawack Health, and funded by GSK.
Legal entity responsible for the study
GSK.
Funding
This study was funded by GSK (213403).
Disclosure
A.L.O. Ortega Granados: Financial Interests, Personal, Full or part-time Employment: Servicio Andaluz de Salud; Financial Interests, Personal, Advisory Board: Roche, Bristol Myers Squibb, Merck Sharp Dohme. S.M. Lim: Financial Interests, Personal, Research Grant: Yuhan, Janssen; Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, Eli Lilly, Takeda, J Ints Bio, BMS; Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, GSK, Roche, Hengrui, BridgeBio Therapeutics, Oscotec, Daiichi Sankyo. M. Schenker: Financial Interests, Personal and Institutional, Funding, Funding for clinical trial activities.: GSK, BMS, MSD, Roche, AstraZeneca, Merck Serono, Astellas, Amgen, Bayer, BeiGene, Clovis, Gilead, Eli Lilly, Pfizer, Novartis, Sanofi, PharmaMar, AbbVie, Regeneron, Mylan, Samsung Pharmaceuticals, Bioven, Eisai, Five Prime, Daiichi Sankyo. F. de Marinis: Financial Interests, Personal, Speaker's Bureau: Merck, GSK, Roche, Bristol Myers Squibb, AstraZeneca, Novartis; Financial Interests, Personal, Advisory Board: Merck, GSK, Roche, Bristol Myers Squibb, AstraZeneca, Novartis. J.M. Puig: Financial Interests, Institutional, Principal Investigator: CER San Juan, centro polivalente de asistencia e Investigación clinica. D.H. Lee: Financial Interests, Personal, Other, Personal fees: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, CJ Healthcare, Eli Lilly, ChongKeunDang, Janssen, Merck, MSD, Mundipharma, Novartis, Ono, Pfizer, Roche, ST Cube, AbbVie, Takeda, Menarini, BC Pharma, Yuhan; Non-Financial Interests, Personal, Other: Takeda, Blueprint Medicine. E. Arriola: Financial Interests, Personal, Advisory Role: BMS, Roche, MSD, Pfizer, Eli Lilly, AstraZeneca, Boehringer Ingelheim, Takeda; Financial Interests, Personal, Invited Speaker: BMS, Roche, MSD, Pfizer, Eli Lilly, AstraZeneca, Boehringer Ingelheim, Takeda; Financial Interests, Personal, Research Grant: Roche, Pfizer; Financial Interests, Institutional, Funding: BMS, Roche, Pfizer; Financial Interests, Personal, Other, Travel and educational expenses: BMS, MSD, Roche, Eli Lilly; Financial Interests, Personal, Ownership Interest: TrialingHealth S.L. J. Fuentes Pradera: Financial Interests, Personal and Institutional, Principal Investigator: Roche, MSD, AstraZeneca, Pfizer; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Sanofi, Takeda. Z. Szijgyarto: Financial Interests, Institutional, Full or part-time Employment: GSK; Financial Interests, Institutional, Stocks/Shares: GSK. L. Cho: Financial Interests, Institutional, Full or part-time Employment: GSK; Financial Interests, Institutional, Stocks/Shares: GSK. J.S. Ahn: Financial Interests, Personal, Invited Speaker: Roche Korea, Menarini Korea, Pfizer, Boehringer Ingelheim, Kyowa Kirin, Amgen Korea, Yuhan, AstraZeneca Korea, Bayer Korea, Takeda Phar, Novartis Korea, Hanmi, BC World; Financial Interests, Personal, Advisory Role: Immuneoncia, Pharmbio Korea, Yooyoung, Vifor Pharma, Bixink. All other authors have declared no conflicts of interest.