336PPembrolizumab plus chemotherapy versus pembrolizumab monotherapy for PD-L1-positive advanced non-small cell lung cancer in the real world

Abstract Background Immune checkpoint inhibitor (ICI) plus Chemotherapy has now become the new standard treatment for non-small-cell lung cancer (NSCLC). However, little is known about comparison of ICI plus Chemotherapy and ICI monotherapy in the real world. Methods Patients with PD-L1-positive, advanced NSCLC treated with pembrolizumab plus chemotherapy (C group) or pembrolizumab monotherapy (M group) at Sendai Kousei Hospital between May 2015 to June 2019 were included in our study. C group received different treatments depending on histology: Patients with squamous NSCLC were received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]–paclitaxel plus pembrolizumab followed by pembrolizumab maintenance therapy. Patients with non-squamous NSCLC were received pemetrexed and a platinum-based drug plus pembrolizumab followed by pembrolizumab plus pemetrexed maintenance therapy. Two groups were evaluated with respect to adverse event (AE) profiles, objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS). Results The following were observed: patient background (C group/ M group) number of cases 13/ 38 cases, median age 64/ 73 years old, male 76.9/71.1 %, Performance Status 0 or 1/ 2/ ≧3 (13/ 0/ 0) / (36/ 2/ 0), median observation period 5.1/ 7.4 months, development of AEs 100/ 84.2 %, development of immune-rerated AEs (irAEs) 61.5/ 84.2 %, development of irAEs ≥ grade 3 7.7/ 21.1 %. There was no significant difference in the ORR (38.5/ 55.2 %; p = 0.199) and DCR (100/89.5 %; p = 0.561) between two groups. Three months PFS were 100 % in combination group and 76.3 % in monotherapy group. Median PFS wasn’t significant different between the two groups (5.9/ 9.2 months; p = 0.193). PFS within 3 months of treatment start of C group tended to be better than M group. Conclusions Median PFS wasn’t significantly different between the two groups, probably due to the short observation period. PFS within 3 months of treatment start of C group tended to be better than M group. C group had more AEs than M group. However, the frequency of severe irAEs in C group was similar to M group. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure S. Sugawara: Honoraria (self): Ono Pharmaceutical; Honoraria (self): Bristol-Myers Squib; Honoraria (self): MSD; Honoraria (self): AstraZeneca; Honoraria (self): Chugai Pharma; Honoraria (self): Nippon Boehringer Ingelheim; Honoraria (self): Pfizer; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Eli Lilly and Company; Honoraria (self): Novartis; Honoraria (self): Kyowa Hakko Kirin. Y. Toi: Honoraria (self): Ono Pharmaceutical; Honoraria (self): MSD; Honoraria (self): AstraZeneca. Y. Kawashima: Honoraria (self): Chugai Pharma. A. Nakamura: Honoraria (self): MSD; Honoraria (self): Chugai Pharma; Honoraria (self): AstraZeneca. S. Yamanda: Honoraria (self): Kyowa Hakko Kirin; Honoraria (self): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Taiho Pharmaceutical. Y. Kimura: Honoraria (self): Nippon Boehringer Ingelheim. All other authors have declared no conflicts of interest.